• PeriOPerative OUTcome Platform Study – “POP-OUT”

Aim:
Regarding the objectives of the first study within the platform entitled: Association of intraoperative Hemodynamic characteristics with postoperative Complications and Mortality (HeCoMo):  Hypothesis: The hemodynamic characteristics like amounts of intravenously administered fluids, vasopressors, or inotropes are associated with increased postoperative complication rates and severity
as well as postoperative mortality.
– Primary: Short-term postoperative complications according to the Clavien-Dindo classification greater or equal to IIIb
– Secondary: Postoperative mortality (in-hospital, 3-months, one-year).

FOR MORE INFORMATION, PLEASE CONTACT Aarne Feldheiser a.feldheiser@kem-med.com  Dept. of Anaesthesiology, Intensive Care Medicine & Pain Therapy, Evang. Kliniken Essen-Mitte, Huyssens-Stiftung/Knappschaft, 45136 Essen, Germany.

• Cerebrovascular Investigation Related to Circulatory parameters Using Longitudinal Assessments on Transcranial Doppler based Evaluation in Mechanical Circulatory Support. Circulate MCS study

Aim:
Primary Aim: To characterize the relationship between all Transcranial Doppler(TCD)-derived cerebral blood flow(CBF) parameters ( mean blood flow velocity, pulsatility index and autoregulation index) with different systemic flow patterns in Mechanical Circulatory Support(MCS) (type of device, degree of support, native cardiac output, vasopressor/inotrope use, pulsatile vs non- pulsatile, different flow volumes, varied peak flow rates, resistance of systemic circuit measured with pulsatility Index) and develop reference ranges adjusted to age, gender, race, comorbidities & extracranial carotid values.
Secondary aim: To identify the association of individual TCD-derived parameters adjusted for MCS settings, age, gender, race, co-morbidities with adverse neurological events in critically ill patients receiving MCS

FOR MORE INFORMATION, PLEASE CONTACT AArti Sarwal 3160 Allerton Lake Drive, Winston Salem, NC (USA) aartisarwal@gmail.com +1(573) 823-5878

• Core outcome set of daily monitoring of gastrointestinal function in critically ill patients. The COSMOGI Study

Aim:
The purpose of this study is to reach consensus on:
(1) the core outcome measures that should be reported daily in trials assessing
gastrointestinal function or nutrition in critically ill patients.
(2) the definitions of these outcomes.

FOR MORE INFORMATION, PLEASE visit https://cosmogi.site/ and CONTACT:

Kaspar Bachmann, Department of Anaesthesiology and Intensive Care
University of Tartu, Tartu, Estonia kaspar.felix.bachmann@ut.ee

Bethan Jenkins, University Hospital Southampton NHS Trust
Southampton General Hospital Bethan.jenkins@uhs.nhs.uk

• Prospective, multicenter study to validate the GastroIntestinal Dysfunction Score (GIDS) and describe prevalence, outcomes, and management of phosphate disorders in intensive care patients (the GUTPHOS study).

Observational, prospective, multicentre trial. This study does not include any intervention, routine practice in participating sites is observed.

Objectives

Aim 1: To validate the Gastrointestinal Dysfunction Score in predicting mortality and duration of ICU dependency and duration of PN dependency among consecutive adult patients admitted to participating ICUs worldwide.
Aim 2: To identify the prevalence, management practices, and outcomes of Pi abnormalities during the first week of ICU admission in consecutive adult patients admitted to ICUs worldwide.

Recruitment of sites and target population

We aim for 20 ICUs to include adult patients (≥18 y) admitted to ICU during recruitment period. Exclusion criteria: restrictions of care at ICU admission; admitted for treatment as organ donors; continuous chronic home ventilation for neuromuscular disease; declined participation or informed consent; or readmission to ICU during the study period.

Funding: This project received the 2023 ESICM Fresenius Kabi Clinical Nutrition Award.

FOR MORE INFORMATION, PLEASE CONTACT:

Arthur van Zanten, Gelderse Vallei Hospital, Ede, The Netherlands zantena@zgv.nl
Annika Reintam Blaser,  University of Tartu Hospital, Tartu, Estonia annika.reintam.blaser@ut.ee

• Use of Non-Invasive Methods for Intracranial Pressue (ICP) Monitoring in Traumatic Brain Injury when invasive ICP is not available (in Low and Middle Income Countries). The MINIMAL Study

Use of Non-Invasive Methods for Intracranial Pressure (ICP) Monitoring in Traumatic Brain Injury when invasive ICP is not available (in Low income countries). The Minimal TBI study.

Aim:
To develop a consensus and clinical guidance for clinicians who face TBI patients when invasive ICP is not available and using non invasive ICP tools such as transcranial doppler, automated pupillometer and ultrasonographic assessment of optic nerve sheath diameter.

Panel

The panel will be composed by 19 physicians (neurointensivist and neurosurgeons) from high income countries with high experience on management of TBI with invasive and non invasive tools, and 20 physicians ( neurointensivist and neurosurgeons) from low income countries who manage every day TBI patients without invasive ICP from all over the world.

Expected results:
We expect to obtain a number of statements which will be able to guide clinicians in the use of non invasive methods to estimate ICP to treat TBI patients, together with clinical assessment and neuroimaging. We hope that especially in low income countries, this will improve the level of care and the treatment of these patients. The literature search will also offer the possibility to assess the presence of literature and knowledge gaps, which can guide for the development of large multicenter studies on this topic.

Members of the Steering Committee:

Chiara Robba,University of Genoa,Italy
Andres Rubiano, Neuroscience Institute, INUB-MEDITECH Research Group, El Bosque University, Bogotá, Colombia
Fabio Taccone, Erasme University, Bruxelles, Belgium
Geert Meyfroidt, Leuven University,Leuven, Belgium

FOR MORE INFORMATION, PLEASE CONTACT:

Chiara Robba,University of Genoa, Chair of the ESICM NIC Section kiarobba@gmail.com

• A European Survey on MIgRAnts in the Intensive Care Unit – The AMIRA Study

A prospective observational study in 100 ICUs from 10 European countries. A 1 week survey performed 4 times over a 1-year period.

Study population:
Non-national patients residing in the recruiting center country will be defined as migrants. Non-migrants will be considered as belonging to the general population.
Among migrants, sub-groups will be defined a priori:
– Documented migrants: regularly living according to the country’s laws concerning immigration
– Asylum seekers: patients than have filled in an asylum demand
– Refugees: patients that benefit from a refugee status
– Undocumented migrants: patients living irregularly in the country
– Undocumented migrants, asylum seekers and refugees (UMASR) will be compared to documented migrants and to general population (control groups).

Methods and Analysis:

Design: multicentric prospective observationnal study.
Participating Centers: 100 European ICUs in the 10 European countries where immigration was the most important in 2019 (Germany, France, Spain, Greece, United-Kingdom, Italy, Belgium, Sweden, Netherlands, Finland).
Study periods: 4 time one week period (1 week / season at predetermined dates) over 1 year.
Study groups: UMASR, documented migrants and general population.
Non-national patients residing in the recruiting center country will be defined as migrants. Non-migrants will be considered as belonging to the general population. Documented migrants and UMASR will be analyzed separately. Patients will be classified according to their affiliation to the national healthcare system and administrative informations recorded at hospital admission.
Timing:
This study Starting date: 2023
Study Duration: 12 months (it can be extended on request)

Expected result:
This endorsed study will describe the characteristics of UMASR admitted to the ICU (demography, economic and social context, comorbidities, reason for admission, need for invasive support during ICU stay), their outcomes (ICU and hospital survival) compared to general population and documented migrants. To have an insight into the practices related to communication with the patients and his relatives considering language barrier and cultural/religious differences and to end of life process.

FOR MORE INFORMATION, PLEASE CONTACT:

Sami HRAIECH Medical ICU, APHM, Marseille France, Aix Marseille University
Elie AZOULAY, Medical ICU, APHP, France, Paris University

sami.hraiech [ @ ] ap-hm.fr; elie.azoulay [ @ ] ap-hp.fr

• ReLatIonship BEtween implementation of evidence-based and suppoRtive ICU cAre and ouTcomes of patIents with acute respiratOry distress syndrome – The ICU LIBERATION Study

Aim: This study aims to investigate the epidemiology and treatments given to the patients and evaluate the implementation of evidence-based ICU care and its association with the outcomes of patients with ARDS admitted to the ICU. The contents of mechanical ventilation settings, respiratory conditions, and evidence-based ICU care, such as analgesia, sedation, rehabilitation, and nutrition, given to the patients will be collected on a daily basis to perform a robust statistical analysis.

Methods and Analysis: This study will be a prospective observational study, with case enrollment beginning after Ethics Committee approval during the patient enrollment period. Up to 10 patients who meet the inclusion and exclusion criteria will be enrolled in the central online database. Upon admission to the ICU of patients who meet the selection criteria, the principal investigator or collaborator at each collaborating institution will assess their suitability for the study.

Timing:
This study Starting date: June 2023
Study Duration: 60 months (it can be extended on request)
Patient enrollment period: June 2023 to May 2024 (12 months)

Expected result:
This ESICM-endorsed study will reveal the epidemiological outcomes and PICS related-outcomes of ARDS on a large scale. Furthermore, this registry will demonstrate how ICU-ventilated patients with ARDS receive the treatments and evidence-based ICU care during their ICU stay on a daily basis in detail.

FOR MORE INFORMATION, PLEASE CONTACT:

Check for more details on the study webpage here

or contact the research office at liberation-office@googlegroups.com

To take part in the project, please register here

  1. CRF
  2. Protocol
  3. Study explanation sheet
  4. Consent form
  5. Data sharing – authorship secondary analysis
  6. Application form for secondary analysis
  7. Confidentiality Agreement
  8. Ethical approvalAmendment 1Amendment 2

Stefan Schaller, Deputy Clinical Director, Department of Anesthesiology and Operative Intensive Care Medicine (CVK, CCM), Charité – Universitätsmedizin Berlin, Germany at Stefan.schaller [ @ ] charite.de

• Use and management of non-invasive methods to assess intracranial pressure in Traumatic brain injured patients in Low & Middle Income Countries (+ in High Income Countries when there are contraindications to invasive methods): a consensus and clinical recommendation  (USEFUL)

Aim of the consensus: to establish the role and use of non invasive methods for the estimation and management of intracranial pressure, in a context where invasive methods are not available, in particular in low-middle income countries. The consensus will provide a number of recommendations regarding the use of different methods (pupillometer, Transcranial Doppler,optic nerve sheath diameter, Computed Tomography), and a decisional practical algorithm.

Methods and Analysis: Systematic review with GRADING of literature, and Delphi process for the votation of the recommendations.

A panel including 29 experts from all over the world, considering gender diversity and representation of low/ high income countries representatives will be created. An expert methodologist (Nancy Carney) will supervise the literature search, GRADING and the steps of the Delphi process..

Expected result:
The group expects to clarify the importance and role of non-invasive methods assessing intracranial pressure and to provide to clinicians a number of recommendations and practical suggestions for the clinical management of traumatic brain injured patients in a context where invasive ICP is not available.

FOR MORE INFORMATION, PLEASE CONTACT:

Chiara Robba (Italy) at kiarobba [ @ ] gmail.com and Andres Rubiano (Colombia) at rubianoam [ @ ] outlook.com

• Long-term impAct in inTEnsive caRe survivors oF CORonavirus disease 19  (AFTERCOR)

The long-term impact of COVID-19 on neurological, pulmonary, kidney, hepatic dysfunction and health-related quality of life is unknown. We hypothesize that COVID-19 patients, admitted to the ICU, will have various degrees of organ dysfunction up to 2 years post-ICU discharge, which will result in an impaired quality of life.
Primary objective: to assess the long-term impact of COVID-19 on pulmonary, hepatic, cardiac and kidney impairment and recovery, up to 2 years, in survivors discharged from the ICU.
Secondary objective: to assess long-term cognitive, neuropsychiatric and mental health impairments as well as health-related quality of life.

Study Design:
This is an international multi-centre, prospective study of patients who have been infected by SARS-CoV-2, developed symptomatic COVID-19 and were admitted to an ICU because of this disease and its complications. Patients will be studied from time of hospital discharge up to 24 months. Information will be collected on demographics, co-existing illnesses before ICU admission, severity of illness during ICU admission and post-ICU quality of life and organ dysfunction/recovery.

Study population and eligibility:
Enrolment goal is 500 patients who survived COVID-19 infection and were discharged from an ICU.
Inclusion Criteria: a) laboratory-confirmed COVID-19 infection by real-time PCR, b) written informed consent from the patient at the time of discharge from the ICU or hospital, c) age ≥18 years, d) discharge from an ICU
Exclusion Criteria: a) patients unable to complete long-term follow-up, due to logistical problems, b) patient paralyzed before being admitted to hospital for COVID-19, c) history of pulmonary resection d) previous pulmonary transplant, e) documented advanced neurologic disorder for which the patient is presumably unable to carry out 6-min walk test, f) documented psychiatric disease for which the patient is unable to carry out the interviews.

Enrolment and participating sites: Study enrolment began on January 1st 2021. Currently, 14 centres in 11 countries (Italy, Spain, Ireland, United States, Australia, South Africa, Argentina, Brazil, Colombia, Singapore, Japan) are participating whilst more sites are being recruited. Co-enrolment in other studies is possible as long as these are observational only.

FOR MORE INFORMATION, PLEASE CONTACT:

Karin Wildi, University of Queensland, Level 3 | Clinical Sciences Building
Chermside Brisbane, Qld 4032, Australia. k.wildi [ @ ] uq.edu.au

Leaders: Karin Wildi, Gianluigi Li Bassi, John Fraser (University of Queensland, Brisbane QLD Australia); Adrian Barnett (Queensland University of Technology, Brisbane QLD, Australia).

Members of the Steering Committee:

1. Prof Heidi Dalton, Inova Fairfax Hospital, Falls Church, VA, USA
2. Dr Jacky Suen, University of Queensland, Brisbane, Australia
3. Prof Antoni Torres, MD, PhD; Hospital Clinic, Barcelona, Spain
4. Prof Carol Hodgson, PhD FACP BAppSc(PT) MPhil PGDip(Cardio), Monash University, Melbourne, Australia
5. Prof John Laffey, MD, Galway University Hospital, Ireland
6. Prof Carlos Luna, MD, PhD, Buenos Aires, Argentina
7. Dr Mauro Panigada, MD, Policlinico of Milan, Milan, Italy
8. Dr Hergen Buscher, FCICM, EDIC, DEAA, Department of Intensive Care Medicine, St Vincent’s Hospital, Sydney, Australia

Download the Protocol (version of 23 April 2021)

• Prone positioning for invasively ventilated patients with COVID-19: an interactive, web-based, multicenter, observational registry (PROVENT)

PRIMARY and SECONDARY OBJECTIVES:

The primary objective of this study is to define potential clusters of critically ill patients – treated with PP – that are homogeneous in terms of both clinical and treatment characteristics.

The Secondary objectives of this study are:
1) To assess the association between cluster membership and positive short-term outcome (i.e. an improvement in respiratory parameters)
2) To assess the association between cluster membership and positive long-term outcomes, defined here as 28days ventilator free days and patient survival at ICU discharge
3) To describe oxygenation, assessed by PaO2/FiO2 ratio, before and after each PP manoeuvre
4) To describe the clinical circumstances under which clinicians opt for PP
5) To describe PP utilization rates in intensive care units in Italy
6) To describe PP in terms of treatment duration in intensive care units in Italy
7) To describe PP in terms of treatment timing in intensive care units in Italy
8) To investigate the impact of time of prone position ventilation on PaO2/FiO2 ratios after each PP cycle and on days free form ventilation
9) To investigate the impact of PP on renal outcome

DESIGN and POPULATION:

This is an international, multicenter, non-profit, retrospective and prospective observational cohort study. The study is non interventional. Study duration is one year.  We anticipate to finalise the study in May 2022.

Inclusion Criteria and exclusion criteria can be found in the protocol hereunder.

STUDY START DATE
The project is currently recruiting.

FOR MORE INFORMATION, PLEASE CONTACT THE PI:

Silvia De Rosa, Anesthesia and Critical Care Unit, San Bortolo Hospital, Vicenza, Italy, derosa.silvia [ @ ] ymail.com or  ricerca [ @ ] siaarti.it

The Steering Committee members are: Paolo Navalesi, Giorgio Fullin, Dario Gregori, Mario Peta, Daniele Poole, Fabio Toffoletto, Giacomo Bellani, Giuseppe Foti, Francesco Papaccio, Tommaso Pettenuzzo, Emanuele Rezoagli, Nicolò Sella.

Download the Protocol (version of June 2021)

• Development of a core measurement set for studies of interventions to enable communication in adults requiring an artificial airway with or without mechanical support 

Communication with an artificial airway – a Core Outcome Set (COS)

PRIMARY and SECONDARY OBJECTIVES:

We aim to develop international key stakeholder consensus on a COS for studies of interventions designed to enable communication in adults requiring an artificial airway with or without mechanical ventilator support irrespective of care location.

Our specific objectives are to:

  1. Characterise selection and definition of outcomes and measures used in existing studies of interventions designed to enable communication in adults requiring an artificial airway with or without mechanical ventilatorsupport;
  2. Identify outcomes of importance to end usersof communication aids (patients and family); and
  3. Obtain consensus on a COS for future studies of interventions designed to enable communication in adults requiring an artificial airway with or without mechanical ventilator support.
  4. Develop set of measurement tools to measure COS.

DESIGN and POPULATION:

To achieve our objectives we will use methods outlined in the COMET handbook and those endorsed by the COMET initiative.

To achieve our objectives we will use methods outlined in the COMET handbook and those endorsed by the COMET initiative:

Phase 1: Patient/Family Interviews
Phase 2: Delphi Consensus Building Exercise
Phase 3: Consensus Meeting conducted online via Zoom
Phase 4: Instruments to Measure Outcomes

Inclusion Criteria

  1. Adults with, or had an artificial airway within the last 3 years, and/or communication partners of an individual with an artificial airway;
  2. Able to understand, read, and communicate inEnglish;
  3. Access to a telephone and the internet; and
  4. Consent to participate.
  5. Clinician/researcher criteria for participation in the Delphi for listing:
    • Patients, communication partners, and patient user/support group representatives;
    • Expert clinicians (physicians, nurses, speech pathologists, and other allied health professionals); and
    • Researchers in communication aids.
  • Exclusion Criteria
    1. Currently admitted to an acute care hospital setting.

STUDY START DATE
The project is currently recruiting.

FOR MORE INFORMATION, PLEASE CONTACT THE Co-PIs:

Prof. Louise Rose, RN, PhD – ESCIM member.Professor of Critical Care Nursing, Florence Nightingale Faculty of Nursing, Midwifery, and Palliative Care.King’s College London,London, UK.

Dr Amy Freeman-Sanderson PhD, CPSP. Graduate School of Health, University of Technology, Sydney, NSW, Australia.Royal Prince Alfred Hospital, Sydney, NSW, Australia .Critical Care Division, The George Institute for Global Health, Sydney, NSW, Australia .Senior lecturer Speech Pathology.University of Technology Sydney.

Downloads:  Plain Language Summary COS, ETH21-5966 Recruitment emails, ETH21-5966 PIS Phase2 Delphi Clinicians Approved

• Core Outcome Measures for Clinical Effectiveness Trials of Nutritional and Metabolic Interventions in Critical Illness 

An international Modified Delphi Consensus Study (CONCISE) 

PRIMARY OBJECTIVE:

To undertake a modified Delphi consensus process, selecting a core set of patient function outcome measures that should be reported in clinical effectiveness trials of nutritional and metabolic interventions in the critically ill population.

DESIGN and POPULATION:

Modified Delphi methodology to reach consensus on a core set of outcome measures

  • Inclusion criteria:
  • Adults over 18 years of age who are critically ill
  • Intervention: Any nutritional or metabolic intervention delivered during critical illness including enteral and parenteral nutrition
  • Context for use: Primarily for adoption in all research trials and clinical studies evaluating nutritional and metabolic interventions in in critical illness

STUDY START DATE and REGISTRATION:
The project aims to start in 2021

We wish to involve medical professionals from >50__ICUs and _100__patients.

Register your ICU here

Duration: 3 months per round, to a maximum of 9 months (it can be extended on request)

MORE INFORMATION and CONTACT:

Zudin Puthucheary, M.D., Ph.D.,Critical Care and Perioperative Medicine Research Group, Queen Mary University London, London, UK

Members of the Steering Committee:

Michael Hiesmayr, Kenneth Christopher, Jan Gunst, Michael Casaer, Marcel Van De Poll, Rob Van gassel, Jean-Charles Presier, Aileen Hill, Angelique Deman, Kursat Gundogan, Annika Reintam-Blaser, Anne-Francoise Frousseau, Carol Hodgson, Lee-Anne Chapple, Linda Denehey, Melina Castro, Pierre Singer, Carla Sevin, Zheng Yii

Download the protocol  here (version  of 15 March 2021)

• SKin and soft tissue necrotizing INfections in the Intensive Care Unit: a prospective multi-national cohort study

SKin and soft tissue necrotizing INfections in the Intensive Care Unit: a prospective multi-national cohort study 

PRIMARY OBJECTIVE:

To assess hospital (e., ICU and hospital mortality) and medium-term (day-90 and day-180 mortality, functional outcomes and health-related quality of life scores) outcomes.

SECONDARY OBJECTIVES:

To report the clinical presentation and microbiological epidemiology of NSTI and identify independent prognostic factors of mortality and altered quality of life.

DESIGN and POPULATION:

Multinational prospective non-interventional cohort study

  • Inclusion criteria:
  • Age > 18 years
  • Non-opposition to participate in the study
  • Patient with surgically-confirmed NSTI (i.e., macroscopic appearance of tissue during surgery revealing swollen, dull gray tissues with a thin, brownish exudate with or without necrosis)
  • Exclusion criteria: none

STUDY START DATE and REGISTRATION:
The project aims to start in 2021
We wish to involve medical professionals from > 100 ICUs and include 1033 patients
Register your ICU here

MORE INFORMATION and CONTACT:

Nicolas de Prost, M.D., Ph.D., Medical Intensive Care Unit, Hôpital Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France and Groupe de Recherche Clinique CARMAS, Université Paris Est Créteil, Créteil, France nicolas.de-prost@aphp.fr 

Members of the Steering Committee:

Olivier Chosidow, M.D., Ph.D., Department of Dermatology, Hôpital Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France. Olivier.chosidow@aphp.fr

Christian Eckmann, M.D., Ph.D., Department of General, Visceral and Thoracic Surgery, Klinikum Hannoversch-Muenden, Center for Research in Surgicasl Infections, Academic Hospital of Goettingen University, Hannoversch-Muenden, Germany. chr.eckmann@gmx.de

Martin Bruun Madsen, M.D., Ph.D., Department of Anaesthesiology and Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. martin.bruun.madsen.01@regionh.dk

Tomas Urbina, M.D., Medical Intensive Care Unit, Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris, Paris, France. tomas.urbina@aphp.fr

Jan de Waele, M.D., Ph.D., Department of Critical Care Medicine / Surgical Intensive Care Unit, Ghent University Hospital, Gent, Belgium. Jan.DeWaele@UGent.be

We are looking for National Coordinators (NC): Please contact Nicolas De Prost

Download the protocol  here

PRone positioN in patients with spontanEous ventiLation and acute hypoxemic respIratory FailurE (PRONELIFE)

PRIMARY OBJECTIVE:

The primary endpoint is a composite of tracheal intubation and all-cause mortality in the first 14 days after enrolment.

SECONDARY OBJECTIVES:

  • Mortality at day 14
  • Intubation among survivors at day 24
  • Effects on oxygenation defined by the SpO2
  • Days under the oxygen support device
  • Time to tracheal intubation
  • Related complications. The following will be considered complications associated to the prone position:

o Oxygen desaturations (SpO2 <90%)
o Episodes of hemodynamic instability (BPsys < 90mmHg or BPsys drop > 10mmHg if BPsys < 90 before the maneuver)
o Need of orotracheal intubation
o Cardiac arrest
o Displacement of the non-invasive respiratory support device
o Removal of central venous line, if documented
o Displacement of an arterial line, if documented
o Displacement of a urinary catheter, if documented

  • Respiratory rate
  • Dyspnea defined according to the Borg dyspnea scale (APPENDIX v)
  • Duration of invasive mechanical ventilation in those patients who required intubation
  • Ventilation-free days (VFD) at 28 days from ICU admission, defined as the number of days alive and free from IMV during the first 28 days from start of IMV
  • ICU-free days and hospital-free days at day 90
  • Mortality at day 28 and day 90

 

Design

Pragmatic, investigator–initiated, international, multicenter, parallel randomized clinical two–arm trial on acute hypoxemic respiratory failure patients with a respiratory rate of more than 25 breaths per minute, SpO2 < 94% and FiO2 of at least 40% or more by either Venturi facemask, HFNC or NIV/CPAP and, absence of decompensated respiratory acidosis.

Population

We intend to recruit acute hypoxemic respiratory failure patients with a respiratory rate of more than 25 breaths per minute, SpO2 < 94% and FiO2 of at least 40% or more by either Venturi facemask, HFNC, or NIV/CPAP and, absence of decompensated respiratory acidosis during two years. Currently, we expect about 35 centers to participate in the trial.

Demographic data and clinical characteristics on screened patients, regardless of enrolment criteria match, will be recorded (registry). We will randomize 650 patients admitted to the participating centers’ intensive care units and expect each participating center to randomize at least 25 patients who meet all inclusion criteria.

Study Timeline

The total trial duration will be 48 months. The total recruitment period will last for 2 years with a follow-up of 3 months, based on a recruitment rate of 75% for each center. There will be 3 months at the end for final data analysis, reporting and trial close down..

Study start date and Registration

The project aims to start in 2021.
We wish to involve medical professionals from 40 ICUs and 650 patients.

Principal Investigator – Contact

Luis Fernando Morales-Quinteros
Hospital Universitari de Sant Pau, Barcelona, Spain
Institut d’Investigació i Innovació Parc Taulí, Sabadell, Spain luchomq2077@gmail.com

Steering Committee

Luis Morales-Quinteros, Marcus J Schultz, Ary Serpa-Neto, Massimo Antonelli, Domenico L. Grieco, Oriol Roca, Nicole Juffermans, Lluis Blanch, Candelaria de Haro, Diego de Mendoza, Marta Camprubi-Rimblas, Antonio

Download the final protocol here (update 6 Sept.2021). Details on the primary and secondary outcomes here.

• Corona Virus disease (COVID19) in Very Elderly Intensive care Patients (VIPs): COVIP study

The COVID-19 pandemic is threatining numerous countries worldwide. Preliminary reports of critically ill COVID-19 patients in Wuhan (China) and Italy reported a high risk of death in patients with multimorbidity. Also, very old patients with SARS-CoV-2 infections suffered from high mortality rates (1). It is, however, unclear if age alone is an independent risk factor, or if co-morbid conditions and frailty trigger the adverse outcome. During the pandemic, treating and triaging elderly COVID-19 may challenge our health care systems.

COVIP study is a European multicenter study of outcomes and prognostic factors in coronavirus disease (COVID-19) in very old intensive care patients. This international, multicenter study group (VIP-network) will conduct a prospective, observational study to examine the relationship between age, co-morbidities, pretreatment frailty and outcomes in a group of elderly patients receiving critical care for COVID-19.

The coronavirus SARS-CoV-2 is currently affecting thousands of patients across many countries and there is an urgent need to investigate patient characteristics and outcome trajectories.

The VIP network which has previously (2016-2019) conducted the most extensive prospective studies (VIP1VIP2) on elderly ICU patients, is immediately deploying this study of elderly COVID19 patients.

The results will be essential to understand which factors can predict mortality in elderly COVID-19 patients to help to detect these patients early. Furthermore, this study will also be a knowledge base necessary to guide triage decisions in the future.

Register your ICU:

Click  to register your ICU here

Documents:
More information:

Please check the following website: https://vipstudy.org/

(1) Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, et al. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020.

• Multicenter ObserVational Study on PracticE of VeNTilation In Brain Injured PAtIeNts: VENTIBRAIN

 

Rationale :

Several experimental and clinical studies have shown how brain injury can cause secondary lung injury. Lung injury could be due either to mechanical ventilation- often necessary in brain injured patients- or to inflammatory response that follows primary acute brain injury. The concept of ‘Protective lung ventilation’ has shown to reduce morbidity and mortality of intensive care unit (ICU) patients with acute respiratory distress syndrome (ARDS) but seems also to have a beneficial effect on patients with healthy lungs and in the perioperative settings. However, these recommendations often come into conflict with the management of patients affected by acute brain injury, in which permissive hypercapnia and increased intrathoracic pressure as consequence of protective ventilation strategies can be dangerous.

Objective :

This observational study aims to determine the ventilation practice of consecutive intubated and ventilated neuro-ICU patients in the first week from admission in intensive care units.

1. Primary objective is to determine ventilation settings of intubated and mechanically ventilated neurocritically ill patients admitted to the ICU.
2. Secondary objectives are:

    • The association of ventilator settings and targets with outcome in the whole population
    • The differences in ventilator settings among different countries
    • To assess the incidence of pulmonary complications (including pneumonia, ARDS, neurogenic pulmonary edema) in this cohort of patients.
    • To assess the ventilator settings applied when intracranial pressure is raised (>20 mmHg).

Study design:

This is an international multi–center prospective observational study.

Study population:

This study will include all consecutive brain injured patients (traumatic brain injury (TBI) or cerebrovascular) intubated and ventilated in ICU and observed for a 7–day period.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Seen the observational design of the study, there is no patient burden. Collection of data from ICU and hospital charts and/or (electronic) medical records systems is of no risk to patients.

Ethical committee:

Documents for applying to the Ethical committee will be provided in few months.

Please check IRB/ethical committee approval process locally.

Participation and contact: 

If you are interested, please contact Dr Chiara Robba or ventibrain@gmail.com

Core Steering Committee: 

Chiara Robba (Principal Investigator)
Paolo Pelosi
Giuseppe Citerio
Fabio Taccone

Extended Steering Committee :

Robert Stevens
Geert Meyfroidt
Mauro Oddo
Rafael Badenes (NC Spain)
Valentina Della Torre (NC UK)
Reymund Helbock
Jose’ Suarez
Nino Stocchetti
Marcelo Abreu
Marcus Schultz
Ary Serpa Neto
Raphael Cinotti (NC France)
Louis Blanch
Giacomo Bellani
Karim Asehnoune
Luigi Camporota
Christian Putensen
John Laffey