Protocol and statistical analysis plan for the Mode of Ventilation During Critical IllnEss (MODE) trial.

Autor:	Seitz KP; Vanderbilt University Medical Center, Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Nashville, TN., Lloyd BD; Vanderbilt University Medical Center, Department of Emergency Medicine, Nashville, TN., Wang L; Vanderbilt University Medical Center, Department of Biostatistics, Nashville, TN., Shotwell MS; Vanderbilt University Medical Center, Department of Biostatistics, Nashville, TN., Qian ET; Vanderbilt University Medical Center, Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Nashville, TN., Richardson RK; Vanderbilt University Medical Center, Department of Respiratory Care, Nashville, TN., Rooks JC; Vanderbilt University Medical Center, Department of Respiratory Care, Nashville, TN., Hennings-Williams V; Vanderbilt University Medical Center, Department of Respiratory Care, Nashville, TN., Sandoval CE; Vanderbilt University Medical Center, Department of Respiratory Care, Nashville, TN., Richardson WD; Vanderbilt University Medical Center, Department of Respiratory Care, Nashville, TN., Morgan T; Vanderbilt University Medical Center, Department of Respiratory Care, Nashville, TN., Thompson AN; Vanderbilt University Medical Center, Department of Respiratory Care, Nashville, TN., Hastings PG; Vanderbilt University Medical Center, Department of Respiratory Care, Nashville, TN., Ring TP; Vanderbilt University Medical Center, Department of Respiratory Care, Nashville, TN., Stollings JL; Vanderbilt University Medical Center, Department of Pharmaceutical Services, Nashville, TN., Talbot EM; Vanderbilt University Medical Center, Department of Medicine, Nashville, TN., Krasinski DJ; Vanderbilt University Medical Center, Department of Medicine, Nashville, TN., Decoursey B; Vanderbilt University Medical Center, Department of Medicine, Nashville, TN., Gibbs KW; Section on Pulmonary, Critical Care, Allergy, and immunology, Wake Forest School of Medicine, Winston-Salem, NC., Self WH; Vanderbilt University Medical Center, Department of Emergency Medicine, Nashville, TN.; Vanderbilt University Medical Center, Vanderbilt Institute for Clinical and Translational Research, Nashville, TN., Mixon AS; Vanderbilt University Medical Center, Department of Medicine, Division of General Internal Medicine and Public Health, Nashville, TN.; VA Tennessee Valley Healthcare System, Geriatric Research, Education, and Clinical Center, Nashville, TN., Rice TW; Vanderbilt University Medical Center, Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Nashville, TN., Semler MW; Vanderbilt University Medical Center, Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Nashville, TN., Casey JD; Vanderbilt University Medical Center, Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Nashville, TN.
Jazyk:	angličtina
Zdroj:	MedRxiv : the preprint server for health sciences [medRxiv] 2023 Jul 24. Date of Electronic Publication: 2023 Jul 24.
DOI:	10.1101/2023.07.21.23292998
Abstrakt:	Introduction: For every critically ill adult receiving invasive mechanical ventilation, clinicians must select a mode of ventilation. The mode of ventilation determines whether the ventilator directly controls the tidal volume or the inspiratory pressure. Newer hybrid modes allow clinicians to set a target tidal volume, for which the ventilator controls and adjusts the inspiratory pressure. A strategy of low tidal volumes and low plateau pressure improves outcomes, but the optimal mode to achieve these targets is not known. Methods and Analysis: The Mode of Ventilation During Critical Illness (MODE) trial is a cluster-randomized, multiple-crossover pilot trial being conducted in the medical intensive care unit (ICU) at an academic center. The MODE trial compares the use of volume control, pressure control, and adaptive pressure control. The study ICU is assigned to a single ventilator mode (volume control versus pressure control versus adaptive pressure control) for continuous mandatory ventilation during each 1-month study block. The assigned mode switches every month in a randomly generated sequence. The primary outcome is ventilator-free days (VFDs) to study day 28, defined as the number of days alive and free of invasive mechanical ventilation from the final receipt of mechanical ventilation to 28 days after enrollment. Enrollment began November 1, 2022 and will end on July 31, 2023. Ethics and Dissemination: The trial was approved by the Vanderbilt University Medical Center institutional review board (IRB# 220446). Results of this study will be submitted to a peer-reviewed journal and presented at scientific conferences. Trial Registration Number: The trial was registered with clinicaltrials.gov on October 3, 2022, prior to initiation of patient enrollment on November 1, 2022 (ClinicalTrials.gov identifier: NCT05563779). Competing Interests: Conflicts of interest and financial disclosures: J.D.C. reports a travel support from Fisher & Paykel Healthcare. T.W.R. reports unrelated consultant relationships with Cumberland Pharmaceuticals, Inc as Director of Medical Affairs, Cytovale, Inc, and Sanofi, Inc as a member of a DSMB.
Databáze:	MEDLINE
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