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
. 2024 Dec 30;25(1):855.
doi: 10.1186/s13063-024-08669-7.

Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial

Karen J Bosma #  1 , Myriam Lafreniere-Roula #  2 , Arlene Jiang  3 , Anna Heath  4   5 , Yongdong Ouyang  4   6 , Kaitlyn Wade  7 , Pingzhao Hu  8 , Karen E A Burns  9 , Claudio M Martin  10 , Yoanna Skrobik  11 , Sorcha Mulligan  2 , Kevin E Thorpe #  12 , Laurent Brochard #  13 ; members of the Canadian Critical Care Trials Group and the REVA Network
Collaborators, Affiliations

Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (the PROMIZING study): update to the statistical analysis plan for a randomized controlled trial

Karen J Bosma et al. Trials. .

Abstract

Background: We previously published the protocol and statistical analysis plan for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study in Trials ( https://doi.org/10.1186/s13063-023-07163-w ). This update summarizes changes made to the statistical analysis plan for the trial since the publication of the original protocol and statistical analysis plan.

Methods/design: The Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation (PROMIZING) study is a multi-center, open-label, randomized controlled trial designed to determine if ventilation with proportional assist ventilation with load-adjustable gain factors will result in a shorter duration of time spent on mechanical ventilation compared to ventilation with pressure support ventilation for patients with acute respiratory failure. The statistical analysis plan for the trial was incorporated into the original publication of the protocol in Trials ( https://doi.org/10.1186/s13063-023-07163-w ) and was based on version 5.0 of the study protocol and version 1.0 of the statistical analysis plan (SAP), which included plans for both frequentist and Bayesian analyses. We have since updated the SAP to refine the Bayesian analysis plan, update the multistate model diagram, and include plans for a cluster analysis to determine if there is heterogeneity of treatment effect. This update summarizes the changes made and their rationale and provides a refined SAP for the PROMIZING trial with additional background information, in adherence with guidelines for the prospective reporting of SAPs for randomized controlled trials.

Trial registration: ClinicalTrials.gov Identifier: NCT02447692 prospectively registered May 19, 2015.

Keywords: Bayesian; Cluster; Liberation; Proportional assist ventilation; Statistical analysis plan; Ventilator-free days; Weaning from mechanical ventilation.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: Ethics approval was granted from the Western University Research Ethics Board through Clinical Trials Ontario (CTO #0733) for the PROMIZING study. Written, informed consent to participate will be obtained from all participants or their Substitute Decision Maker (SDM). All centers participating in the study get their own ethics committee approval. Consent for publication: Not applicable. Competing interests: The authors declare they have no direct competing interests in the study. The study received partial industry funding through the first grant which was a CIHR-industry partnership, with the industry partner at arm’s length. The industry partner, Medtronic, has no role in the study design, data collection, analysis, interpretation, or publication of manuscript. No author received personal financial remuneration for the study. The authors declare no other competing interests in the study.

Figures

Fig. 1
Fig. 1
State transition diagram. IMV, invasive mechanical ventilation; SBT, spontaneous breathing trials; TMT, tracheostomy mask trials; ICU, intensive care unit
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Bosma KJ, Read BA, BahrgardNikoo MJ, Jones PM, Priestap FA, Lewis JF. A pilot randomized trial comparing weaning from mechanical ventilation on pressure support versus proportional assist ventilation. Crit Care Med. 2016;44(6):1098–108. 10.1097/CCM.0000000000001600. PMID: 26807682. - PubMed
    1. Carteaux G, Mancebo J, Mercat A, Dellamonica J, Richard JC, Aguirre-Bermeo H, Kouatchet A, Beduneau G, Thille AW, Brochard L. Bedside adjustment of proportional assist ventilation to target a predefined range of respiratory effort. Crit Care Med. 2013;41(9):2125–32. 10.1097/CCM.0b013e31828a42e5. PMID: 23787397. - PubMed
    1. Bosma KJ, Martin CM, Burns KEA, et al. Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study. Trials. 2023;24:232. 10.1186/s13063-023-07163-w. - PMC - PubMed
    1. Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the content of statistical analysis plans in clinical trials. JAMA. 2017;318(23):2337–43. 10.1001/jama.2017.18556. PubMed PMID: 29260229. - PubMed
    1. Hemming K, Kearney A, Gamble C, et al. Prospective reporting of statistical analysis plans for randomised controlled trials. Trials. 2020;21:898. 10.1186/s13063-020-04828-8. - PMC - PubMed

Publication types

Associated data

LinkOut - more resources