Acute Respiratory FailureMETEORNCT05523479
The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial
A study testing Traditional online education, Interprofessional education and Clinical protocol in people with Acute Respiratory Failure and Airway Extubation, run by University of Pittsburgh at 17 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Airway Extubation
- What is being tested?
- Traditional online education, Interprofessional education and Clinical protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,857 participants
- Where
- 17 sitesUnited States
- Study dates
- 1 Mar 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults treated with invasive mechanical ventilation >24 hours in participating ICUs
Who cannot join
- None
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
UPMC Carlisle
Carlisle, Pennsylvania, 17015
UPMC Hanover
Hanover, Pennsylvania, 17331
UPMC Harrisburg
Harrisburg, Pennsylvania, 17101
UPMC Community Osteopathic
Harrisburg, Pennsylvania, 17109
UPMC West Shore
Mechanicsburg, Pennsylvania, 17050
UPMC East
Monroeville, Pennsylvania, 15146
UPMC Jameson
New Castle, Pennsylvania, 16105
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
UPMC St. Margaret
Pittsburgh, Pennsylvania, 15215
UPMC Mercy
Pittsburgh, Pennsylvania, 15219
UPMC Shadyside
Pittsburgh, Pennsylvania, 15232
UPMC Passavant
Pittsburgh, Pennsylvania, 15237
UPMC Northwest
Seneca, Pennsylvania, 16346
UPMC Williamsport
Williamsport, Pennsylvania, 17701
UPMC Memorial
York, Pennsylvania, 17408
About this study
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).
Read the detailed description
Nearly one million patients require invasive mechanical ventilation for acute respiratory failure in the United States each year. Most of these patients will recover to the point of extubation, yet even those who are extubated remain vulnerable to complications and poor outcomes. Multiple high-profile randomized controlled trials have shown that two preventive post-extubation respiratory therapies-noninvasive ventilation (NIV) and high-flow nasal cannula oxygen (HFNC)-can prevent recurrent respiratory failure, reintubation, and death in this population. Despite this evidence, however, these therapies remain severely underutilized, leading to preventable morbidity and mortality. To address this implementation gap, the investigators will conduct the Maximizing Extubation outcomes Through Educational and Organizational Research (METEOR) Trial, a cluster-randomized, stepped-wedge, type 2 hybrid effectiveness-implementation trial of interprofessional education about preventive post-extubation NIV and HFNC with and without clinical protocols. The METEOR Trial was designed based on extensive preliminary studies, during which the investigators identified barriers to adoption of preventive post-extubation respiratory care and pilot tested interprofessional education as an implementation strategy in the ICU. These studies revealed that a major barrier to implementation is the lack of a shared understanding about the value of these therapies within the interprofessional ICU team; a theory-based interprofessional education intervention designed to create a shared understanding and support "transactive memory" among team members is both feasible and acceptable; and interprofessional education can be strengthened by linking it with a clinical protocol. During the METEOR Trial, the investigators will randomize ICUs to one of four implementation strategies: an active control, protocol-directed care, interprofessional education, or a combination of protocol-directed care and interprofessional education. In parallel, the investigators will randomize ICUs to one of two clinical strategies, one emphasizing either post- extubation NIV or HFNC based on patient risk vs. one emphasizing post-extubation HFNC for all patients.
- Conditions
- Acute Respiratory Failure, Airway Extubation
- Being tested
- Traditional online education, Interprofessional education, Clinical protocol, Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC), Preventive post-extubation high-flow nasal cannula oxygen (HFNC)
- Keywords
- Interprofessional Education, Clinical Protocols, Noninvasive Ventilation, Oxygen Inhalation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional online educationBehavioural
A 30-60 minute, online, interactive, educational video that is customized to each provider type and offered with provider-specific continuing education credits
Interprofessional educationBehavioural
Interprofessional education (IPE) consists of both classroom-based IPE and just-in-time IPE. In classroom-based IPE, a trained physician educator with content expertise who works in the ICU leads a 60-to-90-minute, in-person, IPE workshop consisting of a 30-minute didactic session and a 30-to-60-minute small group session, during which participants work together to apply the content to authentic cases. The workshops, which are designed according to modern principles of adult learning and IPE, present the rationale and evidence supporting the preventive, post-extubation therapies. They are specifically designed to foster authenticity, reinforce role identity, and relate the content to life experience. In just-in-time IPE, trained local champions meet with the interprofessional ICU team each morning to identify eligible patients and, as needed, briefly review the evidence supporting proper use of the assigned preventive, post-extubation strategy.
Clinical protocolBehavioural
An "adequately explicit" protocol provides specific rules for use of the preventive, post-extubation therapy based on patient data. A "ready-to-customize" version of the protocol with instructions to work with key local stakeholders to revise the protocol, accounting for local needs and resources, is provided. After local customization, a local champion then disseminates the protocol based on local practices.
Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)Other
Preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients
Preventive post-extubation high-flow nasal cannula oxygen (HFNC)Other
Preventive post-extubation HFNC for all eligible patients (without risk stratification)
| Study group | Role | What they receive |
|---|---|---|
| Online education about risk-stratified post-extubation NIV/HFNC | Active comparator | During this period, ICU providers receive traditional online education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC. Receives: Behavioral: Traditional online education; Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC) |
| Interprofessional education about risk-stratified post-extubation NIV/HFNC | Active comparator | During this period, ICU providers receive interprofessional education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC. Receives: Behavioral: Interprofessional education; Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC) |
| Clinical protocol about risk-stratified post-extubation NIV/HFNC | Active comparator | During this period, ICU providers deploy a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC. Receives: Behavioral: Clinical protocol; Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC) |
| Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC | Active comparator | During this period, ICU providers receive interprofessional education and use a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC. Receives: Behavioral: Interprofessional education; Behavioral: Clinical protocol; Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC) |
| Online education about post-extubation HFNC | Active comparator | During this period, ICU providers receive traditional online education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of preventive post-extubation HFNC for all eligible patients. Receives: Behavioral: Traditional online education; Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC) |
| Interprofessional education about post-extubation HFNC | Active comparator | During this period, ICU providers receive interprofessional education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of preventive post-extubation HFNC for all eligible patients. Receives: Behavioral: Interprofessional education; Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC) |
| Clinical protocol about post-extubation HFNC | Active comparator | During this period, ICU providers deploy a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients. Receives: Behavioral: Clinical protocol; Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC) |
| Interprofessional education plus clinical protocol about post-extubation HFNC | Active comparator | During this period, ICU providers receive interprofessional education and use a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients. Receives: Behavioral: Interprofessional education; Behavioral: Clinical protocol; Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC) |
| Usual care | No intervention | During this period, ICU providers receive no structured education about preventive, post-extubation respiratory support therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 days after initiating invasive mechanical ventilation
In-hospital mortality truncated at 60 days from intubation (primary clinical outcome)
Defined as the number of participants who died during hospitalization
Measured: 60 days after initiating invasive mechanical ventilation
Secondary outcomes (10)
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)
Measured: Up to 3 years
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
Measured: 6 months after the implementation intervention (IPE plus protocol) is fully deployed
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)
Measured: 90 days after initiating invasive mechanical ventilation
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
Measured: 60 days after initiating invasive mechanical ventilation
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
Measured: 60 days after initiating invasive mechanical ventilation
Post-extubation respiratory failure
Defined as reintubation and resumption of invasive mechanical ventilation during the 48 hours after extubation
Measured: 60 days after initiating invasive mechanical ventilation
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
Measured: 60 days after initiating invasive mechanical ventilation
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
Measured: 28 days after initiating invasive mechanical ventilation
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
Measured: Up to 60 days after initiating invasive mechanical ventilation
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
Measured: Up to 60 days after initiating invasive mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Mar 2023
- Primary completion31 Jan 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The METEOR Trial is a batched stepped wedge cluster randomized type 2 hybrid implementation-effectiveness trial. ICUs are randomized rather than individuals, and each ICU will cross over from control to intervention at a randomized timepoint. The trial will employ three variations on the traditional stepped wedge design: 1. A factorial design will be used to estimate the effects of two implementation strategies (IPE and a clinical protocol) separately as well as together. 2. A concurrent design will be used to compare two post-extubation strategies (HFNC for all patients vs. NIV for high-risk patients and HFNC for low-risk patients) with conventional post-extubation oxygen therapy and with each other. 3. A batched design allows for the recruitment of clusters (i.e., ICUs) throughout the duration of the trial rather than requiring that all clusters commence participation in the trial at the same time.
- Masking
- None (open label)
- Enrolment
- 12,857 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Timothy Girard, MD, MSCI, University of Pittsburgh
- Investigators
- Timothy D Girard, MD, MSCI, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523479
- Sponsor's protocol ID
- STUDY20100469
- Other IDs
- U01HL159882
- Acronym
- METEOR
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2022
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The University of Pittsburgh will comply with applicable NIH guidelines on data sharing as published online. The investigators will make scientific data as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. Data will be shared as elements that meet or exceed the HIPAA Privacy Rule definition of "safe harbor de-identified" data, so that the rights and privacy of human subjects who participate in research are protected at all times. Principles and guidelines as outlined by the NIH Office of Technology Transfer will be observed in sharing all scientific resources.
Publications
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.
PubMed 27818331Rochwerg 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.
PubMed 28860265Granton 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.
PubMed 32947472Sang 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.
PubMed 32802452Fernando 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.
PubMed 34825256Argote L, Miron-Spektor E. Organizational learning: From experience to knowledge. Organization Science 2011;22:1123-37.
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.
PubMed 35596691Prendergast NT, Kahn JM, Angus DC, Argote L, Barnes B, Chang CH, Graff S, Hess DR, Onyemekwu CA, Rak KJ, Russell JL, Seaman JB, Toth KM, Girard TD. Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial: protocol for a batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness-implementation trial. BMJ Open. 2025 Oct 23;15(10):e108956. doi: 10.1136/bmjopen-2025-108956.
PubMed 41130691
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial
- ClinicalTrials.gov ID
- NCT05523479
- Acronym / sponsor ID
- METEOR / STUDY20100469
- Conditions
- Acute Respiratory Failure, Airway Extubation
- Keywords
- Interprofessional Education, Clinical Protocols, Noninvasive Ventilation, Oxygen Inhalation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,857 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Nearly one million patients require invasive mechanical ventilation for acute respiratory failure in the United States each year. Most of these patients will recover to the point of extubation, yet even those who are extubated remain vulnerable to complications and poor outcomes. Multiple high-profile randomized controlled trials have shown that two preventive post-extubation respiratory therapies-noninvasive ventilation (NIV) and high-flow nasal cannula oxygen (HFNC)-can prevent recurrent respiratory failure, reintubation, and death in this population. Despite this evidence, however, these therapies remain severely underutilized, leading to preventable morbidity and mortality. To address this implementation gap, the investigators will conduct the Maximizing Extubation outcomes Through Educational and Organizational Research (METEOR) Trial, a cluster-randomized, stepped-wedge, type 2 hybrid effectiveness-implementation trial of interprofessional education about preventive post-extubation NIV and HFNC with and without clinical protocols. The METEOR Trial was designed based on extensive preliminary studies, during which the investigators identified barriers to adoption of preventive post-extubation respiratory care and pilot tested interprofessional education as an implementation strategy in the ICU. These studies revealed that a major barrier to implementation is the lack of a shared understanding about the value of these therapies within the interprofessional ICU team; a theory-based interprofessional education intervention designed to create a shared understanding and support "transactive memory" among team members is both feasible and acceptable; and interprofessional education can be strengthened by linking it with a clinical protocol. During the METEOR Trial, the investigators will randomize ICUs to one of four implementation strategies: an active control, protocol-directed care, interprofessional education, or a combination of protocol-directed care and interprofessional education. In parallel, the investigators will randomize ICUs to one of two clinical strategies, one emphasizing either post- extubation NIV or HFNC based on patient risk vs. one emphasizing post-extubation HFNC for all patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- The METEOR Trial is a batched stepped wedge cluster randomized type 2 hybrid implementation-effectiveness trial. ICUs are randomized rather than individuals, and each ICU will cross over from control to intervention at a randomized timepoint. The trial will employ three variations on the traditional stepped wedge design: 1. A factorial design will be used to estimate the effects of two implementation strategies (IPE and a clinical protocol) separately as well as together. 2. A concurrent design will be used to compare two post-extubation strategies (HFNC for all patients vs. NIV for high-risk patients and HFNC for low-risk patients) with conventional post-extubation oxygen therapy and with each other. 3. A batched design allows for the recruitment of clusters (i.e., ICUs) throughout the duration of the trial rather than requiring that all clusters commence participation in the trial at the same time.
| Arm | Type | Receives |
|---|---|---|
| Online education about risk-stratified post-extubation NIV/HFNC | Active comparator | Behavioral: Traditional online education, Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)During this period, ICU providers receive traditional online education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC. |
| Interprofessional education about risk-stratified post-extubation NIV/HFNC | Active comparator | Behavioral: Interprofessional education, Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)During this period, ICU providers receive interprofessional education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC. |
| Clinical protocol about risk-stratified post-extubation NIV/HFNC | Active comparator | Behavioral: Clinical protocol, Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)During this period, ICU providers deploy a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC. |
| Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC | Active comparator | Behavioral: Interprofessional education, Behavioral: Clinical protocol, Other: Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)During this period, ICU providers receive interprofessional education and use a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC. |
| Online education about post-extubation HFNC | Active comparator | Behavioral: Traditional online education, Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC)During this period, ICU providers receive traditional online education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of preventive post-extubation HFNC for all eligible patients. |
| Interprofessional education about post-extubation HFNC | Active comparator | Behavioral: Interprofessional education, Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC)During this period, ICU providers receive interprofessional education that demonstrates the evidence supporting use of preventive post-extubation respiratory support (NIV or HFNC) over conventional post-extubation oxygen and supports the implementation of preventive post-extubation HFNC for all eligible patients. |
| Clinical protocol about post-extubation HFNC | Active comparator | Behavioral: Clinical protocol, Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC)During this period, ICU providers deploy a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients. |
| Interprofessional education plus clinical protocol about post-extubation HFNC | Active comparator | Behavioral: Interprofessional education, Behavioral: Clinical protocol, Other: Preventive post-extubation high-flow nasal cannula oxygen (HFNC)During this period, ICU providers receive interprofessional education and use a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients. |
| Usual care | No intervention | –During this period, ICU providers receive no structured education about preventive, post-extubation respiratory support therapies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults treated with invasive mechanical ventilation >24 hours in participating ICUs
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional online educationA 30-60 minute, online, interactive, educational video that is customized to each provider type and offered with provider-specific continuing education credits | Behavioural | Online education about post-extubation HFNC, Online education about risk-stratified post-extubation NIV/HFNC |
| Interprofessional educationInterprofessional education (IPE) consists of both classroom-based IPE and just-in-time IPE. In classroom-based IPE, a trained physician educator with content expertise who works in the ICU leads a 60-to-90-minute, in-person, IPE workshop consisting of a 30-minute didactic session and a 30-to-60-minute small group session, during which participants work together to apply the content to authentic cases. The workshops, which are designed according to modern principles of adult learning and IPE, present the rationale and evidence supporting the preventive, post-extubation therapies. They are specifically designed to foster authenticity, reinforce role identity, and relate the content to life experience. In just-in-time IPE, trained local champions meet with the interprofessional ICU team each morning to identify eligible patients and, as needed, briefly review the evidence supporting proper use of the assigned preventive, post-extubation strategy. | Behavioural | Interprofessional education about post-extubation HFNC, Interprofessional education about risk-stratified post-extubation NIV/HFNC, Interprofessional education plus clinical protocol about post-extubation HFNC, Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC |
| Clinical protocolAn "adequately explicit" protocol provides specific rules for use of the preventive, post-extubation therapy based on patient data. A "ready-to-customize" version of the protocol with instructions to work with key local stakeholders to revise the protocol, accounting for local needs and resources, is provided. After local customization, a local champion then disseminates the protocol based on local practices. | Behavioural | Clinical protocol about post-extubation HFNC, Clinical protocol about risk-stratified post-extubation NIV/HFNC, Interprofessional education plus clinical protocol about post-extubation HFNC, Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC |
| Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)Preventive post-extubation NIV for high-risk patients and preventive post-extubation HFNC for low-risk patients | Other | Clinical protocol about risk-stratified post-extubation NIV/HFNC, Interprofessional education about risk-stratified post-extubation NIV/HFNC, Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC, Online education about risk-stratified post-extubation NIV/HFNC |
| Preventive post-extubation high-flow nasal cannula oxygen (HFNC)Preventive post-extubation HFNC for all eligible patients (without risk stratification) | Other | Clinical protocol about post-extubation HFNC, Interprofessional education about post-extubation HFNC, Interprofessional education plus clinical protocol about post-extubation HFNC, Online education about post-extubation HFNC |
Primary outcome
Rate of use of post-extubation NIV or HFNC among eligible participants (primary implementation outcome)
Time frame: 60 days after initiating invasive mechanical ventilation
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
In-hospital mortality truncated at 60 days from intubation (primary clinical outcome)
Time frame: 60 days after initiating invasive mechanical ventilation
Defined as the number of participants who died during hospitalization
10 secondary outcomes
Number of eligible participants receiving care from providers who completed an implementation intervention
Time frame: Up to 3 years
Use of post-extubation NIV or HFNC among eligible participants 6 months after the implementation intervention (IPE plus protocol) is fully deployed
Time frame: 6 months after the implementation intervention (IPE plus protocol) is fully deployed
90-day survival
Time frame: 90 days after initiating invasive mechanical ventilation
ICU length of stay
Time frame: 60 days after initiating invasive mechanical ventilation
Hospital length of stay
Time frame: 60 days after initiating invasive mechanical ventilation
Post-extubation respiratory failure
Time frame: 60 days after initiating invasive mechanical ventilation
Duration of mechanical ventilation
Time frame: 60 days after initiating invasive mechanical ventilation
28-day ventilator-free days (VFDs)
Time frame: 28 days after initiating invasive mechanical ventilation
Ventilator-associated events (VAEs)
Time frame: Up to 60 days after initiating invasive mechanical ventilation
Organ failure (daily SOFA)
Time frame: Up to 60 days after initiating invasive mechanical ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 27818331Ouellette 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.
- Background: PubMed 28860265Rochwerg 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.
- Background: PubMed 32947472Granton 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.
- Background: PubMed 32802452Sang 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.
- Background: PubMed 34825256Fernando 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.
- BackgroundArgote L, Miron-Spektor E. Organizational learning: From experience to knowledge. Organization Science 2011;22:1123-37.
- Background: PubMed 35596691Kasza 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.
- Derived from this study: PubMed 41130691Prendergast NT, Kahn JM, Angus DC, Argote L, Barnes B, Chang CH, Graff S, Hess DR, Onyemekwu CA, Rak KJ, Russell JL, Seaman JB, Toth KM, Girard TD. Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial: protocol for a batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness-implementation trial. BMJ Open. 2025 Oct 23;15(10):e108956. doi: 10.1136/bmjopen-2025-108956.
- Individual participant dataSharing planned: Yes. The University of Pittsburgh will comply with applicable NIH guidelines on data sharing as published online. The investigators will make scientific data as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. Data will be shared as elements that meet or exceed the HIPAA Privacy Rule definition of "safe harbor de-identified" data, so that the rights and privacy of human subjects who participate in research are protected at all times. Principles and guidelines as outlined by the NIH Office of Technology Transfer will be observed in sharing all scientific resources.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy D Girard, MD, MSCI principal investigator
University of Pittsburgh
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional online education, Interprofessional education and Clinical protocol in people with Acute Respiratory Failure and Airway Extubation, run by University of Pittsburgh at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of use of post-extubation NIV or HFNC among eligible participants (primary implementation outcome) (time frame: 60 days after initiating invasive mechanical ventilation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05523479, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.