CLINICAL TRIALS IN INTENSIVE CARE
TUESDAY SEPTEMBER 26TH
#LIVES2017
Twitter Chair: Matthew J. Rowland, Oxford, United Kingdom
The newest clinical trials are in the spotlight of this featured session led by ICM Editor-in-Chief Elie Azoulay (Paris, France) and Lui Forni (Surrey, United Kingdom). Results from a wide range of topical trials will be presented for the first time and many will be followed with publications in key medical journals. Don’t miss this session that will surely serve as a catalyst for discussion during and long after…
Watch LIVE in Vienna or ONLINE HERE!
Featured presentations:
Reconnection to mechanical ventilation for one hour after a successful spontaneous breathing trial reduces reintubation in critically ill patients: A multicentre randomised controlled trial?
In general, all of us need rest after a muscular effort. Moreover, studies about protocolised vs non-protocolised weaning show that a protocolised weaning significantly reduced the total duration of ventilation being the current clinical practice. In some countries, patients are reconnected to the ventilator after the effort of spontaneously breathing until a physician decides extubation. In some studies, investigators reconnected patients to the ventilator for a period after successful spontaneous breathing trials to determine whether minute ventilation recovery was a predictor of extubation outcome. All these studies inadvertently enabled patients to rest for a while before extubation.
However, the effects of resting by itself after the effort of a spontaneous breathing trial has never been purposely studied, so the objective of our study was to evaluate whether reconnection to mechanical ventilation for one hour after the effort of a successful SBT could reduce reintubation in critically ill patients. We performed a prospective, randomised, multicentre trial in 17 mixed medical-surgical ICU around Spain. Patients under mechanical ventilation more than 12 hours were screened daily and followed prospectively (while undergoing serial SBTs) until they successfully completed an SBT. When patients fulfilled criteria for planned extubation after a successful SBT, they were randomly allocated to direct extubation as usual clinical practice (Control group) or reconnected to the ventilator for a one-hour rest before extubation (Rest group). The primary endpoint was reintubation within 48h.
~ Maria del Mar Fernandez
Randomised, multi-centre trial of lateral-trendelenburg versus semi-recumbent body position for the prevention of ventilator-associated pneumonia
The Gravity-VAP trial is the largest randomised trial ever conducted to test the efficacy of body position in the prevention of ventilator-associated pneumonia. This trial was designed to compare the lateral-Trendelenburg position with the semi-recumbent position in patients expected to be intubated and mechanically ventilated for periods longer than 48 hours.
The study was conducted in collaboration with some of the most prestigious European research centers and in 2011 it was endorsed by the European Society of Intensive Care Medicine
~ Gianluigi Li Bassi
Early goal-directed nutrition versus standard of care in adult intensive care patients: The single-centre, randomised, outcome assessor-blinded EAT-ICU trial
The objective of the randomised EAT-ICU trial was to assess the effects of individualised energy and protein nutrition optimised by indirect calorimetry and 24-hour urinary urea excretion (nitrogen balance) on physical quality of life at 6 months in acutely admitted, adult ICU patients. We hypothesised that the early goal-directed nutrition (EGDN) would improve physical quality of life at 6-months compared to standard nutrition care in patients admitted to the ICU.
~ Matilde Jo Allingstrup (presented by Anders Perner)
Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome
Recent experimental animal models with acute respiratory distress syndrome (ARDS) have shown that the more physiology-driven airway pressure release ventilation (APRV) methodologies may significantly improve alveolar recruitment and gas exchange, increased homogeneity, and attenuate lung injury, without circulatory depression. Nonetheless, data on ARDS are limited and usually derived from small clinical trials in which variable outdated APRV settings have been used, consequently, the findings of these studies are controversial. As such APRV remains an unproven therapy for patients with ARDS. We hypothesised that in patients with ARDS, early application of the updated APRV methodology would better improve oxygenation and respiratory system compliance and reduce the duration of mechanical ventilation compared to conventional low tidal volume lung protective ventilation (LTV).
A total of 138 patients with ARDS who received mechanical ventilation for < 48 hours between May 2015 to October 2016 while in ICU were enrolled in the study. Patients were randomly assigned to receive APRV (n = 71) or LTV (n=67). The updated APRV settings were: high airway pressure (Phigh) set at the last plateau airway pressure (Pplat, set at a maximum of 30 cmH2O) and low airway pressure (Plow) set at 5 cmH2O; the release phase (Tlow) setting adjusted to terminate the peak expiratory flow rate to ≥ 50%; release frequency of 10-14 cycles/min; initially spontaneous respiratory level was targeted as spontaneous minute ventilation, approximately 30% total minute ventilation. The settings for LTV were: target tidal volume of 6mL/PBW, Pplat not exceeding 30cmH2O, and PEEP guided by the PEEP-FiO2 combination table according to ARDSnet protocol. The primary outcome was the ventilator-free days from enrollment to day 28. The secondary endpoints included oxygenation, Pplat, respiratory system compliance and patient outcomes.
~ Yan Kang
Biomarker-based strategy for early discontinuation of empirical antifungal treatment in critically ill patients: A randomised controlled trial
The use of a biomarker-based strategy is helpful for early discontinuation of empirical antifungal treatment in critically ill patients with suspected invasive candida infection, with no negative impact on outcome.
~ Saad Nseir
What impact will these trials have on practice at the bedside?
Beyond the cutting-edge results, what do these trials mean? We’ve invited commentators to bring their expertise to discuss the implications of the research presented. If you have comments and questions for speaker or commentator, bring them to this top session or forward them on social media #LIVES2017. Find the full list of clinical trial presentations and commentators here:
Reconnection to mechanical ventilation for one hour after a successful spontaneous breathing trial reduces reintubation in critically ill patients: A multicentre randomised controlled trial?
Speaker: Maria del Mar Fernandez, Barcelona, Spain
Commentator: Jordi Mancebo Cortes, Montreal, Canada
Randomised, multi-centre trial of lateral-trendelenburg versus semi-recumbent body position for the prevention of ventilator-associated pneumonia
Speaker: Gianluigi Li Bassi, Barcelona, Spain
Commentator: Ignacio Martin-Loeches, Dublin, Ireland
Early goal-directed nutrition versus standard of care in adult intensive care patients: The single-centre, randomised, outcome assessor-blinded EAT-ICU trial
Speaker: Matilde Jo Allingstrup, Copenhagen, Denmark
Commentator: Jean-Charles Preiser, Brussels, Belgium
Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome
Speaker: Yan Kang, Chengdu, China
Commentator: Samir Jaber, Montpellier, France
Terminal weaning or immediate extubation for withdrawing mechanical ventilation in critically ill patients (the ARREVE Observational Study)
Speaker: Jean Reignier, Nantes, France
Commentator: J. Randall Curtis, Seattle, United States
Biomarker-based strategy for early discontinuation of empirical antifungal treatment in critically ill patients: A randomised controlled trial
Speaker: Saad Nseir, Lille, France
Commentator: George Dimopoulos, Athens, Greece
Pooled analysis of higher vs lower blood pressure targets for vasopressors
Speaker: François Lamontagne, Sherbrooke, Canada
Commentator: Jan Bakker, Rotterdam, Netherlands
Join this exciting clinical trials session LIVE in Vienna…
Thematic Session ~ CLINICAL TRIALS IN INTENSIVE CARE
26.09.2017, 16:00 – 17:59, room VIENNA
Or watch LIVE ONLINE HERE!
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