250 Participants Needed

Noninvasive Ventilation for Extubation Failure in Obesity

Recruiting at 3 trial locations
RK
BM
RN
Overseen ByRahul Nanchal, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rush University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for extubation failure in obesity?

Research shows that high-flow nasal cannula (HFNC) and noninvasive ventilation (NIV) can help reduce the risk of needing to be re-intubated (having a breathing tube put back in) after extubation in obese patients. HFNC has been found to be as effective as NIV in preventing breathing problems after extubation in high-risk patients.12345

Is noninvasive ventilation safe for humans?

High-flow nasal cannula (HFNC) and other noninvasive ventilation methods like CPAP and BiPAP are generally considered safe for humans, with studies showing good safety profiles in both adults and children for various respiratory conditions.13678

How does noninvasive ventilation differ from other treatments for extubation failure in obesity?

Noninvasive ventilation (NIV) is unique because it provides respiratory support without the need for invasive procedures, helping to improve oxygenation and reduce the risk of reintubation in obese patients after extubation. Unlike high-flow nasal cannula (HFNC), which is another non-invasive option, NIV may be more beneficial for certain high-risk subgroups, potentially offering better outcomes in preventing reintubation.124910

What is the purpose of this trial?

Around 20% of the obese patients with higher body mass index (BMI) who are taken off the breathing tube and breathing machine (ventilator) end up needing it back to support breathing. The re-application of breathing tube is associated with poor outcomes, including high risk of pneumonia, longer hospital stays, and death. The purpose of this study is to assess if prophylactic use of noninvasive breathing support after removing the breathing tube lowers the chance of needing the breathing tube again.

Research Team

RK

Ramandeep Kaur, PhD

Principal Investigator

Rush University Medical Center

BM

Babak Mokhlesi, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

This trial is for adults over 18 who are severely obese with a BMI of at least 40 kg/m2, have been on a ventilator for more than 24 hours, and are about to be taken off the breathing tube. They must also have stable blood acidity levels. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

My medical team plans to remove my breathing tube.
Arterial pH ≥7.35 or venous pH ≥ 7.31 within 30 mins of spontaneous breathing trial (SBT)
BMI ≥40 kg/m2
See 1 more

Exclusion Criteria

I am considering or have decided on a compassionate extubation.
Underlying neuromuscular disease
I or my family have not requested to be put back on a breathing machine.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either HFNC alone or NIV alternating with HFNC for 24 hours after extubation

24 hours

Follow-up

Participants are monitored for treatment failure and reintubation within 7 days of extubation

7 days

Treatment Details

Interventions

  • High flow nasal cannula
  • Noninvasive ventilation alternating with high flow nasal cannula
Trial Overview The study is testing whether using noninvasive ventilation methods like masks or nasal high flow oxygen right after removing the breathing tube can prevent severely obese patients from needing the tube put back in.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Group (NIV with HFNC)Experimental Treatment1 Intervention
Patients randomized to the intervention group will receive NIV alternating with HFNC for 24 hours after extubation
Group II: Control Group (HFNC alone)Active Control1 Intervention
Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+

Medical College of Wisconsin

Collaborator

Trials
645
Recruited
1,180,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials
974
Recruited
361,000+

Hospital Civil de Guadalajara

Collaborator

Trials
51
Recruited
11,200+

Findings from Research

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.
Direct Extubation to High-Flow Nasal Cannula versus Noninvasive Ventilation in Obese Subjects.Magdy, DM., Metwally, A.[2023]
In a study of 757 obese patients, high-flow nasal cannula (HFNC) therapy was found to be as effective as non-invasive ventilation (NIV) in preventing reintubation after extubation, with no significant difference in overall reintubation risk.
For patients with a body mass index (BMI) of 40 kg/m² or higher, HFNC significantly reduced the risk of reintubation within 96 hours, suggesting it may be particularly beneficial for severely obese patients, despite being associated with longer hospital and ICU stays.
Effect of high-flow nasal cannula versus non-invasive ventilation after extubation on successful extubation in obese patients: a retrospective analysis of the MIMIC-IV database.Ge, Y., Li, Z., Xia, A., et al.[2023]
High flow nasal cannula (HFNC) is effective in treating adult patients with acute hypoxemic respiratory failure in the emergency department, showing benefits like improved oxygenation and reduced need for intubation, particularly in conditions such as pneumonia and COVID-19.
While HFNC is generally safe, careful monitoring is essential, especially for patients with severe respiratory distress, as they may require additional interventions if HFNC fails.
High flow nasal cannula for adult acute hypoxemic respiratory failure in the ED setting.Long, B., Liang, SY., Lentz, S.[2022]

References

Direct Extubation to High-Flow Nasal Cannula versus Noninvasive Ventilation in Obese Subjects. [2023]
Effect of high-flow nasal cannula versus non-invasive ventilation after extubation on successful extubation in obese patients: a retrospective analysis of the MIMIC-IV database. [2023]
High flow nasal cannula for adult acute hypoxemic respiratory failure in the ED setting. [2022]
Benefit with preventive noninvasive ventilation in subgroups of patients at high-risk for reintubation: a post hoc analysis. [2022]
Comparison of outcomes of high-flow nasal cannula and noninvasive positive-pressure ventilation in patients with hypoxemia and various APACHE II scores after extubation. [2021]
Predicting High Flow Nasal Cannula Failure in an Intensive Care Unit Using a Recurrent Neural Network With Transfer Learning and Input Data Perseveration: Retrospective Analysis. [2022]
High flow nasal cannula therapy in the pediatric home setting. [2023]
Modified high-flow nasal cannula for children with respiratory distress. [2022]
[Use of high-flow nasal oxygen therapy after extubation]. [2022]
10.United Statespubmed.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]
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