Educational Strategies for Extubation Outcomes

(METEOR Trial)

Recruiting 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

13018 Participants Needed

Trial Summary

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 data supports the effectiveness of this treatment?

Research suggests that high-flow nasal cannula (HFNC) oxygen therapy can reduce the need for reintubation (putting a tube back into the airway) compared to standard oxygen therapy, especially in patients at high risk of breathing problems after extubation (removal of the breathing tube). HFNC is also considered as effective as non-invasive ventilation (NIV) in preventing breathing issues in these patients. ^{1 2 3 4 5}

Is high-flow nasal cannula (HFNC) oxygen therapy safe for humans?

High-flow nasal cannula (HFNC) oxygen therapy has been studied in various settings, including intensive care units and postoperative care, and is generally considered safe for humans. It has been shown to reduce the need for reintubation (putting a tube back into the airway) compared to standard oxygen therapy and is as effective as noninvasive ventilation (NIV) in preventing respiratory failure after extubation. ^{3 4 5 6 7}

How does the treatment for extubation outcomes differ from other treatments?

This treatment is unique because it combines high-flow nasal cannula oxygen (HFNC) with noninvasive ventilation (NIV) to prevent respiratory failure after extubation, especially in high-risk patients. Unlike standard oxygen therapy, this approach aims to reduce the need for reintubation by providing more effective respiratory support. ^{1 3 4 5 8}

What is the purpose of this trial?

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).

Research Team

Timothy D Girard, MD, MSCI

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Use of high-flow nasal oxygen therapy after extubation]. [2022]

2. England pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients after planned extubation: a systematic review and meta-analysis. [2020]

3. India pubmed.ncbi.nlm.nih.gov

Comparative evaluation of high-flow nasal cannula oxygenation vs nasal intermittent ventilation in postoperative paediatric patients operated for acyanotic congenital cardiac defects. [2023]

4. England pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula oxygen therapy alone or with non-invasive ventilation during the weaning period after extubation in ICU: the prospective randomised controlled HIGH-WEAN protocol. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula to prevent postextubation respiratory failure in high-risk non-hypercapnic patients: a randomized multicenter trial. [2022]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Direct Extubation to High-Flow Nasal Cannula versus Noninvasive Ventilation in Obese Subjects. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Effectiveness of high-flow nasal cannulae compared with noninvasive positive-pressure ventilation in preventing reintubation in patients receiving prolonged mechanical ventilation. [2023]