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01-12-2020 | Acute Respiratory Distress-Syndrome | Study protocol

Model-based PEEP titration versus standard practice in mechanical ventilation: a randomised controlled trial

Authors: Kyeong Tae Kim, Sophie Morton, Sarah Howe, Yeong Shiong Chiew, Jennifer L. Knopp, Paul Docherty, Christopher Pretty, Thomas Desaive, Balazs Benyo, Akos Szlavecz, Knut Moeller, Geoffrey M. Shaw, J. Geoffrey Chase

Published in: Trials | Issue 1/2020

Abstract

Background

Positive end-expiratory pressure (PEEP) at minimum respiratory elastance during mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS) may improve patient care and outcome. The Clinical utilisation of respiratory elastance (CURE) trial is a two-arm, randomised controlled trial (RCT) investigating the performance of PEEP selected at an objective, model-based minimal respiratory system elastance in patients with ARDS.

Methods and design

The CURE RCT compares two groups of patients requiring invasive MV with a partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio ≤ 200; one criterion of the Berlin consensus definition of moderate (≤ 200) or severe (≤ 100) ARDS. All patients are ventilated using pressure controlled (bi-level) ventilation with tidal volume = 6–8 ml/kg. Patients randomised to the control group will have PEEP selected per standard practice (SPV). Patients randomised to the intervention will have PEEP selected based on a minimal elastance using a model-based computerised method. The CURE RCT is a single-centre trial in the intensive care unit (ICU) of Christchurch hospital, New Zealand, with a target sample size of 320 patients over a maximum of 3 years. The primary outcome is the area under the curve (AUC) ratio of arterial blood oxygenation to the fraction of inspired oxygen over time. Secondary outcomes include length of time of MV, ventilator-free days (VFD) up to 28 days, ICU and hospital length of stay, AUC of oxygen saturation (SpO₂)/FiO₂ during MV, number of desaturation events (SpO₂ < 88%), changes in respiratory mechanics and chest x-ray index scores, rescue therapies (prone positioning, nitric oxide use, extracorporeal membrane oxygenation) and hospital and 90-day mortality.

Discussion

The CURE RCT is the first trial comparing significant clinical outcomes in patients with ARDS in whom PEEP is selected at minimum elastance using an objective model-based method able to quantify and consider both inter-patient and intra-patient variability. CURE aims to demonstrate the hypothesized benefit of patient-specific PEEP and attest to the significance of real-time monitoring and decision-support for MV in the critical care environment.

Trial registration

Australian New Zealand Clinical Trial Registry, ACTRN12614001069640. Registered on 22 September 2014.

(https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366838&isReview=true) The CURE RCT clinical protocol and data usage has been granted by the New Zealand South Regional Ethics Committee (Reference number: 14/STH/132).

Available only for authorised users

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Title: Model-based PEEP titration versus standard practice in mechanical ventilation: a randomised controlled trial
Authors: Kyeong Tae Kim
Sophie Morton
Sarah Howe
Yeong Shiong Chiew
Jennifer L. Knopp
Paul Docherty
Christopher Pretty
Thomas Desaive
Balazs Benyo
Akos Szlavecz
Knut Moeller
Geoffrey M. Shaw
J. Geoffrey Chase
Publication date: 01-12-2020
Publisher: BioMed Central
Keyword: Acute Respiratory Distress-Syndrome
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-019-4035-7

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Model-based PEEP titration versus standard practice in mechanical ventilation: a randomised controlled trial

Abstract

Background

Methods and design

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods and design

Discussion

Trial registration

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