Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
[Preprint]. 2023 Jul 24:2023.07.21.23292998.
doi: 10.1101/2023.07.21.23292998.

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

Kevin P Seitz  1 , Bradley D Lloyd  2 , Li Wang  3 , Matthew S Shotwell  3 , Edward T Qian  1 , Roger K Richardson  4 , Jeffery C Rooks  4 , Vanessa Hennings-Williams  4 , Claire E Sandoval  4 , Whitney D Richardson  4 , Tracy Morgan  4 , Amber N Thompson  4 , Pamela G Hastings  4 , Terry P Ring  4 , Joanna L Stollings  5 , Erica M Talbot  6 , David J Krasinski  6 , Bailey Decoursey  6 , Kevin W Gibbs  7 , Wesley H Self  2   8 , Amanda S Mixon  9   10 , Todd W Rice  1 , Matthew W Semler  1 , Jonathan D Casey  1
Affiliations

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

Kevin P Seitz et al. medRxiv. .

Update in

  • Protocol and Statistical Analysis Plan for the Mode of Ventilation During Critical Illness (MODE) Trial.
    Seitz KP, Lloyd BD, Wang L, Shotwell MS, Qian ET, Richardson RK, Rooks JC, Hennings-Williams V, Sandoval CE, Richardson WD, Morgan T, Thompson AN, Hastings PG, Ring TP, Stollings JL, Talbot EM, Krasinski DJ, Decoursey B, Gibbs KW, Self WH, Mixon AS, Rice TW, Semler MW, Casey JD. Seitz KP, et al. CHEST Crit Care. 2024 Mar;2(1):100033. doi: 10.1016/j.chstcc.2023.100033. Epub 2023 Nov 25. CHEST Crit Care. 2024. PMID: 38742219 Free PMC article.

Abstract

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).

Keywords: Artificial; Critical Illness; Feasibility Studies; Respiration; Respiratory Failure.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1.
Figure 1.. Group assignment during the MODE trial.
For each of the 1-month study periods, the study unit is randomly assigned to a study mode for continuous mandatory ventilation. The letters ‘A’, ‘B’, and ‘C’ each correspond to one of the three study modes.
See this image and copyright information in PMC

References

    1. Wunsch H, Angus DC, Harrison DA, Linde-Zwirble WT, Rowan KM. Comparison of Medical Admissions to Intensive Care Units in the United States and United Kingdom. Am J Respir Crit Care Med 2011;183(12):1666–73. - PubMed
    1. Wunsch H, Linde-Zwirble WT, Angus DC, Hartman ME, Milbrandt EB, Kahn JM. The epidemiology of mechanical ventilation use in the United States*: Critical Care Medicine 2010;38(10):1947–53. - PubMed
    1. Adhikari NK, Fowler RA, Bhagwanjee S, Rubenfeld GD. Critical care and the global burden of critical illness in adults. The Lancet 2010;376(9749):1339–46. - PMC - PubMed
    1. Writing Group for the PReVENT Investigators, Simonis FD, Serpa Neto A, et al. Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without ARDS: A Randomized Clinical Trial. JAMA 2018;320(18):1872. - PMC - PubMed
    1. Acute Respiratory Distress Syndrome Network. Ventilation with Lower Tidal Volumes as Compared with Traditional Tidal Volumes for Acute Lung Injury and the Acute Respiratory Distress Syndrome. N Engl J Med 2000;342(18):1301–8. - PubMed

Publication types

Associated data