Noninvasive Ventilation for Extubation Failure in Obesity

Recruiting at 3 trial locations

Overseen By Rahul Nanchal, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Pregnant, Neuromuscular disease, COPD, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

250 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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. ^{2 3 8 9 10}

Who Is on the Research Team?

Ramandeep Kaur, PhD

Principal Investigator

Rush University Medical Center

Babak Mokhlesi, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intervention Group (NIV with HFNC) Experimental Treatment 1 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 Control 1 Intervention

Patients randomized to the intervention group will receive HFNC only for 24 hours after extubation

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+

Published Research Related to This Trial

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High flow nasal cannula for adult acute hypoxemic respiratory failure in the ED setting. Long, B., Liang, SY., Lentz, S.[2022]

In a study of 604 high-risk patients, those with 4 or more risk factors for reintubation had significantly lower rates of reintubation when treated with noninvasive ventilation (NIV) compared to high-flow nasal cannula (HFNC), suggesting NIV may be more effective for this subgroup.

Overweight patients (BMI ≥ 25 kg/m2) showed an increased risk of reintubation when treated with HFNC, indicating that HFNC may not be the best preventive therapy for them, while further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit with preventive noninvasive ventilation in subgroups of patients at high-risk for reintubation: a post hoc analysis. Hernández, G., Vaquero, C., Ortiz, R., et al.[2022]

In a study of 120 patients with acute hypoxemic respiratory failure, high-flow nasal cannula (HFNC) treatment resulted in significantly lower rates of abdominal distension compared to noninvasive positive-pressure ventilation (NPPV), indicating a safer profile for HFNC.

Both HFNC and NPPV showed similar effectiveness in preventing respiratory failure post-extubation, with no significant differences in key respiratory parameters or re-intubation rates, suggesting that HFNC may be a preferable option due to its lower incidence of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of outcomes of high-flow nasal cannula and noninvasive positive-pressure ventilation in patients with hypoxemia and various APACHE II scores after extubation. Shang, X., Wang, Y.[2021]

A study involving 834 trials of high flow nasal cannula (HFNC) in critically ill children demonstrated that machine learning models, particularly long short-term memory (LSTM) models, can effectively predict HFNC failure within 24 hours, which is crucial for timely escalation of respiratory support.

The best-performing LSTM model achieved an area under the receiver operating characteristic (AUROC) of 0.78, indicating a strong ability to identify patients at risk of needing more invasive ventilation compared to traditional logistic regression models, which had lower AUROC scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Pappy, G., Aczon, M., Wetzel, R., et al.[2022]

In a study of 75 children using home high-flow nasal cannula (HFNC) therapy, it was found to be safe and well tolerated, with no serious adverse events reported.

HFNC therapy led to significant improvements in weight gain and a reduction in hospitalization days, along with high parental satisfaction, indicating its efficacy in managing various respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High flow nasal cannula therapy in the pediatric home setting. Ehrlich, S., Golan Tripto, I., Lavie, M., et al.[2023]

The study involved 74 children aged 1 month to 5 years with acute respiratory distress, comparing a low-cost modified high-flow nasal cannula (HFNC) to a standard commercial HFNC.

Both systems showed similar effectiveness and safety in terms of intubation rates and adverse events, but nurses reported higher satisfaction with the commercial HFNC, suggesting that the modified version could be a viable alternative in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified high-flow nasal cannula for children with respiratory distress. Itdhiamornkulchai, S., Preutthipan, A., Vaewpanich, J., et al.[2022]

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]

Citations

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

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

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

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]

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

High flow nasal cannula for adult acute hypoxemic respiratory failure in the ED setting. [2022]

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

Benefit with preventive noninvasive ventilation in subgroups of patients at high-risk for reintubation: a post hoc analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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]

6. Canada pubmed.ncbi.nlm.nih.gov

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]

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

High flow nasal cannula therapy in the pediatric home setting. [2023]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Modified high-flow nasal cannula for children with respiratory distress. [2022]

9. France pubmed.ncbi.nlm.nih.gov

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

10. 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]