Noninvasive Ventilation for Extubation Failure in Obesity

Recruiting at 4 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?

This trial aims to determine if noninvasive breathing support can help obese patients breathe more easily after the removal of a breathing tube. The goal is to reduce the number of patients needing the tube reinserted, which can lead to complications like pneumonia and extended hospital stays. Participants will be divided into two groups: one will use a high-flow nasal cannula (a tube delivering oxygen through the nose), while the other will use both the nasal cannula and a noninvasive ventilator. Individuals who have been on a breathing machine for at least 24 hours, have a high body mass index (BMI of 40 or more), and are scheduled for breathing tube removal might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance post-operative care for obese patients.

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 prior data suggests that noninvasive ventilation and high flow nasal cannula are safe for extubation failure in obesity?

Research has shown that using noninvasive ventilation (NIV) after removing a breathing tube is generally safe for obese patients. One study found that NIV reduced the likelihood of needing the tube again within 72 hours, resulting in fewer treatment failures. Another study suggested that applying NIV immediately after tube removal can improve outcomes for these patients.

In summary, studies indicate that NIV is well-tolerated and may effectively reduce risks following breathing tube removal in obese patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to prevent extubation failure in obese patients. Unlike the standard care options that typically involve just high flow nasal cannula (HFNC) or noninvasive ventilation (NIV) alone, this trial examines the combination of HFNC and alternating NIV. This method could enhance respiratory support immediately after extubation, potentially reducing the risk of respiratory complications. By alternating between these two methods, the trial aims to provide more tailored support, addressing the unique respiratory needs of obese patients and potentially improving recovery outcomes.

What evidence suggests that this trial's treatments could be effective for extubation failure in obesity?

Research has shown that using noninvasive ventilation (NIV) along with a high flow nasal cannula (HFNC) can help prevent breathing issues after removing a breathing tube in high-risk patients. In this trial, participants in the intervention group will receive NIV alternating with HFNC. Studies suggest this combination might be more effective than using HFNC alone in avoiding the need to reinsert the breathing tube, possibly because NIV offers more breathing support. For patients with obesity, who are more likely to experience trouble after tube removal, both HFNC and NIV present promising options. Early use of these methods can lower the risk of breathing failure and the need to reinsert the tube. ^{6 7 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.

BMI ≥40 kg/m2

Arterial pH ≥7.35 or venous pH ≥ 7.31 within 30 mins of spontaneous breathing trial (SBT)

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+

Central DuPage Hospital

Collaborator

Trials

15

Recruited

3,900+

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

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]

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 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 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]

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 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]

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]

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]

Citations

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Noninvasive respiratory support following extubation in ... Patients with obesity are at high-risk of extubation failure. Discrepancies were found in the results of recent randomized controlled trials (RCTs) regarding ...

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Does obesity impact on weaning from invasive ventilation Our findings that patients with obesity in the WEAN SAFE cohort had lower levels of sedation when ready to wean, and received more respiratory ...

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Effect of non-invasive ventilation after extubation in ... For routine management following extubation of critically ill patients with obesity, using NIV is safe and decreases treatment failure within 72 h. High ...

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Humidified Noninvasive Ventilation versus High-Flow ... Conclusions: Among adult critically ill patients with obesity at intermediate risk for extubation failure, the rate of reintubation was not ...

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the multicentre randomised EXTUB-OBESE study protocol Our hypothesis is that NIV is associated with less treatment failure compared with oxygen therapy in patients with obesity after extubation in ICU.

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Extubation Failure Among Patients With Obesity - CHEST Study analysis shows that patients with obesity were older and received significantly more careful preparation before extubation and management after extubation ...