Acute Respiratory Failure Clinical Trial
— METEOROfficial title:
The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial
Verified date | April 2024 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The METEOR Trial will compare four implementation strategies-traditional online education, protocol-directed care, interprofessional education, and a combination of protocol-directed care and interprofessional education-to test the hypotheses that interprofessional education is superior to traditional online education as an implementation strategy in the intensive care unit (ICU) and the benefits of interprofessional education are increased when interprofessional education is paired with a clinical protocol. Additionally, the trial will also test the hypothesis that preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients are both superior to current clinical practice (i.e., conventional post-extubation oxygen therapy).
Status | Enrolling by invitation |
Enrollment | 16800 |
Est. completion date | February 2026 |
Est. primary completion date | November 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All adults treated with invasive mechanical ventilation >24 hours in participating ICUs Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Argote L, Miron-Spektor E. Organizational learning: From experience to knowledge. Organization Science 2011;22:1123-37.
Fernando SM, Tran A, Sadeghirad B, Burns KEA, Fan E, Brodie D, Munshi L, Goligher EC, Cook DJ, Fowler RA, Herridge MS, Cardinal P, Jaber S, Moller MH, Thille AW, Ferguson ND, Slutsky AS, Brochard LJ, Seely AJE, Rochwerg B. Noninvasive respiratory support following extubation in critically ill adults: a systematic review and network meta-analysis. Intensive Care Med. 2022 Feb;48(2):137-147. doi: 10.1007/s00134-021-06581-1. Epub 2021 Nov 25. — View Citation
Granton D, Chaudhuri D, Wang D, Einav S, Helviz Y, Mauri T, Mancebo J, Frat JP, Jog S, Hernandez G, Maggiore SM, Hodgson CL, Jaber S, Brochard L, Trivedi V, Ricard JD, Goligher EC, Burns KEA, Rochwerg B. High-Flow Nasal Cannula Compared With Conventional Oxygen Therapy or Noninvasive Ventilation Immediately Postextubation: A Systematic Review and Meta-Analysis. Crit Care Med. 2020 Nov;48(11):e1129-e1136. doi: 10.1097/CCM.0000000000004576. — View Citation
Kasza J, Bowden R, Hooper R, Forbes AB. The batched stepped wedge design: A design robust to delays in cluster recruitment. Stat Med. 2022 Aug 15;41(18):3627-3641. doi: 10.1002/sim.9438. Epub 2022 May 21. — View Citation
Ouellette DR, Patel S, Girard TD, Morris PE, Schmidt GA, Truwit JD, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Kress JP. Liberation From Mechanical Ventilation in Critically Ill Adults: An Official American College of Chest Physicians/American Thoracic Society Clinical Practice Guideline: Inspiratory Pressure Augmentation During Spontaneous Breathing Trials, Protocols Minimizing Sedation, and Noninvasive Ventilation Immediately After Extubation. Chest. 2017 Jan;151(1):166-180. doi: 10.1016/j.chest.2016.10.036. Epub 2016 Nov 3. — View Citation
Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug. — View Citation
Sang L, Nong L, Zheng Y, Xu Y, Chen S, Zhang Y, Huang Y, Liu X, Li Y. Effect of high-flow nasal cannula versus conventional oxygen therapy and non-invasive ventilation for preventing reintubation: a Bayesian network meta-analysis and systematic review. J Thorac Dis. 2020 Jul;12(7):3725-3736. doi: 10.21037/jtd-20-1050. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of use of post-extubation NIV or HFNC among eligible participants (primary implementation outcome) | Defined the number of participants who received post-extubation NIV or HFNC divided by the number of participants eligible for post-extubation NIV or HFNC | 60 days after initiating invasive mechanical ventilation | |
Primary | In-hospital mortality truncated at 60 days from intubation (primary clinical outcome) | Defined as the number of participants who died during hospitalization | 60 days after initiating invasive mechanical ventilation | |
Secondary | Number of eligible participants receiving care from providers who completed an implementation intervention | Defined as the total number of participants who received care from ICU providers (physicians, nurses, and/or respiratory therapists) who completed an implementation intervention (traditional online education, interprofessional education, and/or clinical protocol) | Up to 3 years | |
Secondary | Use of post-extubation NIV or HFNC among eligible participants 6 months after the implementation intervention (IPE plus protocol) is fully deployed | Defined the number of participants who received post-extubation NIV or HFNC divided by the number of participants eligible for post-extubation NIV or HFNC during the one-month period beginning 6 months after the implementation intervention (IPE plus protocol) is fully deployed | 6 months after the implementation intervention (IPE plus protocol) is fully deployed | |
Secondary | 90-day survival | Defined as time from initiating invasive mechanical ventilation to the date of death from any cause or last known follow-up (censored) | 90 days after initiating invasive mechanical ventilation | |
Secondary | ICU length of stay | Defined as time from the time of initiating invasive mechanical ventilation to successful discharge from the ICU, where "successful" indicates that discharge was followed by at least 48 hours alive without ICU readmission | 60 days after initiating invasive mechanical ventilation | |
Secondary | Hospital length of stay | Defined as time from the time of initiating invasive mechanical ventilation to successful hospital discharge, where "successful" indicates that discharge was followed by at least 48 hours alive without hospital readmission | 60 days after initiating invasive mechanical ventilation | |
Secondary | Post-extubation respiratory failure | Defined as reintubation and resumption of invasive mechanical ventilation during the 48 hours after extubation | 60 days after initiating invasive mechanical ventilation | |
Secondary | Duration of mechanical ventilation | Defined as time from the time of initiating invasive mechanical ventilation to successful extubation, where "successful" indicates that extubation was followed by at least 48 hours alive without reintubation | 60 days after initiating invasive mechanical ventilation | |
Secondary | 28-day ventilator-free days (VFDs) | Defined as the number of days a participant was breathing without assistance from the day they of intubation (initiating invasive mechanical ventilation) to 28 days later, where "breathing without assistance" indicates that discontinuation of assisted breathing was followed by at least 48 hours alive without reintubation | 28 days after initiating invasive mechanical ventilation | |
Secondary | Ventilator-associated events (VAEs) | Defined as the number of participants who have a VAE according to Centers of Disease Control and Prevention (CDC) criteria divided by the number of participants who received invasive mechanical ventilation | Up to 60 days after initiating invasive mechanical ventilation | |
Secondary | Organ failure (daily SOFA) | Defined as mean daily sequential organ failure assessment (SOFA) score from initiating invasive mechanical ventilation to up to 60 days later | Up to 60 days after initiating invasive mechanical ventilation |
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