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Educational Strategies for Extubation Outcomes (METEOR Trial)

N/A

Waitlist Available

Led By Timothy D Girard, MD, MSCI

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All adults treated with invasive mechanical ventilation >24 hours in participating ICUs

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare four implementation strategies for ICU care: traditional online education, protocol-directed care, interprofessional education, and a combination of the two. They will test the hypotheses that interprofessional education is superior to traditional online education, and that the benefits of interprofessional education are increased when interprofessional education is paired with a clinical protocol. Additionally, they will test the hypothesis that preventive post-extubation NIV and preventive post-extubation HFNC are both superior to current clinical practice.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves educational and organizational interventions rather than medications, there are no direct side effects like those seen with drugs. However, different oxygen delivery methods may vary in comfort or effectiveness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

In-hospital mortality truncated at 60 days from intubation (primary clinical outcome)

Rate of use of post-extubation NIV or HFNC among eligible participants (primary implementation outcome)

Secondary study objectives

28-day ventilator-free days (VFDs)

90-day survival

Duration of mechanical ventilation

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups

Active Control

Group I: Clinical protocol about post-extubation HFNCActive Control2 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 HFNCActive Control2 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 HFNCActive Control3 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/HFNCActive Control2 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/HFNCActive Control2 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/HFNCActive Control3 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 HFNCActive Control2 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 careActive Control1 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/HFNCActive Control2 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.

0 / 1Eligibility criteria met