Educational Strategies for Extubation Outcomes

(METEOR Trial)

Enrolling by invitation at 14 trial locations

Overseen By Nicole Toney, MPH, CPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 60 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different educational strategies to enhance how ICU staff assist patients in breathing independently after ventilator use. It compares the effectiveness of team-based learning with online classes for medical staff. The trial also evaluates whether advanced oxygen support methods, such as noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC), benefit patients more than standard oxygen therapy. Individuals who have been on a ventilator for over 24 hours in an ICU may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to improving ICU care and patient outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these educational strategies and respiratory support methods are safe for ICU patients?

Research has shown that high-flow nasal cannula (HFNC) therapy is usually well-tolerated. It can help reduce breathing problems and the need to return to a breathing machine within 72 hours after extubation. However, some studies suggest it might not always lower the risk of reintubation or shorten hospital stays compared to regular oxygen therapy.

When combining noninvasive ventilation (NIV) with HFNC, research suggests this approach might be the most effective in preventing breathing issues after extubation. HFNC alone appears to work as well as NIV for patients at high risk of breathing problems post-extubation. However, NIV might delay reintubation if necessary, which is important to consider.

These findings indicate that both HFNC and the combination of NIV and HFNC are generally safe, but their effectiveness can vary depending on the patient's condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new strategies for improving outcomes after removing a breathing tube, known as extubation. Traditionally, patients receive standard oxygen therapy after extubation. This trial tests the effectiveness of using a high-flow nasal cannula (HFNC) and risk-stratified noninvasive ventilation (NIV) as preventive measures to support breathing, potentially reducing complications. By providing interprofessional education and clinical protocols, the trial aims to see if these strategies can better tailor respiratory support to individual patient needs, possibly leading to improved recovery and fewer respiratory issues.

What evidence suggests that this trial's treatments could be effective for extubation outcomes?

Research has shown that high-flow nasal cannula (HFNC) can be more effective than regular oxygen therapy for patients who might need a breathing tube reinserted. In this trial, some participants will receive preventive post-extubation HFNC, while others will receive risk-stratified preventive post-extubation noninvasive ventilation (NIV) or HFNC. Studies have found that HFNC, along with continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP), provides better support for children after breathing tube removal compared to regular oxygen. Additionally, using NIV with HFNC reduces the likelihood of needing the breathing tube again more than HFNC alone, especially in patients with multiple risk factors. Research also indicates that NIV is more effective than HFNC in preventing the need for a breathing tube again in critically ill patients, particularly those with conditions like obesity. These findings suggest that these methods can enhance breathing support after removing a breathing tube. ^{2 3 5 6 7}

Who Is on the Research Team?

Timothy D Girard, MD, MSCI

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

The METEOR Trial is for adults who have been on a ventilator for more than 24 hours in certain ICUs. There are no specific exclusion criteria, so it's open to all eligible patients meeting the inclusion condition.

Inclusion Criteria

I was on a breathing machine for more than a day in the ICU.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation Intervention

ICU providers receive various educational interventions and clinical protocols to implement preventive post-extubation respiratory therapies

6 months

Ongoing education sessions

Treatment

Deployment of preventive post-extubation NIV or HFNC based on patient risk and educational strategy

60 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Clinical protocol
• Interprofessional education
• Preventive post-extubation high-flow nasal cannula oxygen (HFNC)
• Risk-stratified preventive post-extubation noninvasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC)
• Traditional online education

Trial Overview This trial tests four strategies after extubation: traditional online education, protocol-directed care, interprofessional education, and a mix of both education and protocol. It aims to find out if special training or protocols improve patient outcomes compared to usual oxygen therapy.

How Is the Trial Designed?

Group I: Clinical protocol about post-extubation HFNC Active Control 2 Interventions

During this period, ICU providers deploy a clinical protocol that supports the implementation of preventive post-extubation HFNC for all eligible patients.

Group II: Interprofessional education about post-extubation HFNC Active Control 2 Interventions

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.

Group III: Interprofessional education plus clinical protocol about post-extubation HFNC Active Control 3 Interventions

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.

Group IV: Interprofessional education about risk-stratified post-extubation NIV/HFNC Active Control 2 Interventions

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.

Group V: Clinical protocol about risk-stratified post-extubation NIV/HFNC Active Control 2 Interventions

During this period, ICU providers deploy a clinical protocol that supports the implementation of risk-stratified, preventive post-extubation NIV/HFNC.

Group VI: Interprofessional education plus clinical protocol about risk-stratified post-extubation NIV/HFNC Active Control 3 Interventions

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.

Group VII: Online education about post-extubation HFNC Active Control 2 Interventions

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.

Group VIII: Usual care Active Control 1 Intervention

During this period, ICU providers receive no structured education about preventive, post-extubation respiratory support therapies

Group IX: Online education about risk-stratified post-extubation NIV/HFNC Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

High-flow nasal cannula (HFNC) oxygen therapy is effective for patients with mild hypoxemia at extubation, showing a low risk of reintubation (<10%), while noninvasive ventilation (NIV) is beneficial for high-risk patients with a greater chance of extubation failure (>20%).

In postoperative settings, standard oxygen is adequate for patients with a low risk of intubation (<5%), but those with moderate hypoxemia (10-15% risk) may benefit from HFNC, and patients with severe respiratory distress (50% risk) should be considered for NIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of high-flow nasal oxygen therapy after extubation]. Arrivé, F., Rodriguez, M., Frat, JP., et al.[2022]

In a randomized controlled trial involving 120 critically ill obese patients, high-flow nasal cannula (HFNC) significantly reduced the risk of postextubation respiratory failure by 8.4% compared to noninvasive ventilation (NIV).

Although HFNC showed a lower re-intubation rate (11.6% vs 16.6%) compared to NIV, this difference was not statistically significant, indicating that while HFNC may be beneficial, further research is needed to confirm its superiority.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct Extubation to High-Flow Nasal Cannula versus Noninvasive Ventilation in Obese Subjects. Magdy, DM., Metwally, A.[2023]

In a study of 182 critically ill patients at very high risk for extubation failure, noninvasive ventilation (NIV) with active humidification significantly reduced the reintubation rate compared to high-flow nasal cannula (HFNC), with 23.3% of NIV patients requiring reintubation versus 38.8% of HFNC patients.

Patients treated with NIV also had a shorter hospital stay (20 days) compared to those on HFNC (26.5 days), indicating that NIV may not only be more effective in preventing reintubation but also beneficial for overall recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of postextubation noninvasive ventilation with active humidification vs high-flow nasal cannula on reintubation in patients at very high risk for extubation failure: a randomized trial. Hernández, G., Paredes, I., Moran, F., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7324267/

a Randomized Clinical Trial The present study compared clinical outcomes associated with HFNC and conventional oxygen therapy (COT) among patients at high risk for reintubation.

2. nature.com nature.com/articles/s41598-023-31444-8

Effectiveness of high-flow nasal cannulae compared with ... HFNC may not be as effective as NIPPV in preventing reintubation among patients who have been receiving PMV for at least 2 weeks.

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.1026234/full

Efficacy of preventive use of oxygen therapy after planned ... Conclusion: Preventive use of NIV + HFNC after scheduled extubation is probably the most effective respiratory support method for preventing ...

4. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-025-05366-y

Physiological comparison of noninvasive ventilation and high ... In patients at high-risk of extubation failure, prophylactic NIV significantly decreased inspiratory efforts with increased tidal volumes compared to HFNO.

5. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2805373

Association of Extubation Failure Rates With High-Flow ... The results suggest that CPAP, HFNC, and BiPAP were more effective than COT for providing postextubation NRS in a pediatric population.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5395483/

Preventive post-extubation high-flow nasal oxygen therapy ... Both trials demonstrated a decrease in post-extubation ARF and reintubation rates within 72 hours with HFNO as compared to the control group (15,16).

7. accjournal.org accjournal.org/journal/view.php?doi=10.4266/acc.2021.01571

High-flow nasal cannula for respiratory failure in adult ... The risk of reintubation was greatest within the first 6 hours after primary extubation, with consequences such as pneumonia (including ...