Noninvasive Ventilation for Extubation Failure in Obesity

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Ramandeep Kaur, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rush University Medical Center

Disqualifiers: Pregnant, Neuromuscular disease, COPD, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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 3 6 7 8}

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. ^{1 2 4 9 10}

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

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.

Trial 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 (Procedure)
• Noninvasive ventilation alternating with high flow nasal cannula (Procedure)

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

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

McGovern Medical School, The University of Texas Health Science Center Houston, TX

Medical College of Wisconsin Milwaukee, WI

Rush University Medical Center Chicago, IL

Who Is Running the Clinical Trial?

Rush University Medical Center Lead Sponsor

Medical College of Wisconsin Collaborator

The University of Texas Health Science Center, Houston Collaborator

Hospital Civil de Guadalajara Collaborator

References

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

Direct Extubation to High-Flow Nasal Cannula versus Noninvasive Ventilation in Obese Subjects. [2023] Patients who are obese have a higher risk of acute respiratory failure after extubation in the ICU. This study aimed to compare the extubation of subjects who were critically ill and obese to high-flow nasal cannula (HFNC) versus noninvasive ventilation (NIV) to determine whether HFNC can aid in reducing postextubation respiratory failure and the re-intubation rate.

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] The pathophysiological characteristics of the respiratory system of obese patients differ from those of non-obese patients. Few studies have evaluated the effects of high-flow nasal cannula (HFNC) and non-invasive ventilation (NIV) on the prognosis of obese patients. We here compared the effects of these two techniques on the prevention of reintubation after extubation for obese patients.

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

High flow nasal cannula for adult acute hypoxemic respiratory failure in the ED setting. [2022] High flow nasal cannula (HFNC) is a noninvasive ventilation (NIV) system that has demonstrated promise in the emergency department (ED) setting.

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] Label="BACKGROUND" NlmCategory="BACKGROUND">High-flow nasal cannula (HFNC) was shown to be non-inferior to noninvasive ventilation (NIV) for preventing reintubation in a general population of high-risk patients. However, some subgroups of high-risk patients might benefit more from NIV. We aimed to determine whether the presence of many risk factors or overweight (body mass index (BMI) ≥ 25 kg/m2) patients could have different response to any preventive therapy, NIV or HFNC in terms of reduced reintubation rate.

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] The study aimed to compare and analyze the outcomes of high-flow nasal cannula (HFNC) and noninvasive positive-pressure ventilation (NPPV) in the treatment of patients with acute hypoxemic respiratory failure (AHRF) who had extubation after weaning from mechanical ventilation.

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] High flow nasal cannula (HFNC) provides noninvasive respiratory support for children who are critically ill who may tolerate it more readily than other noninvasive ventilation (NIV) techniques such as bilevel positive airway pressure and continuous positive airway pressure. Moreover, HFNC may preclude the need for mechanical ventilation (intubation). Nevertheless, NIV or intubation may ultimately be necessary for certain patients. Timely prediction of HFNC failure can provide an indication for increasing respiratory support.

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

High flow nasal cannula therapy in the pediatric home setting. [2023] High-flow nasal cannula (HFNC) therapy may be better tolerated than traditional noninvasive ventilation (NIV) and is rapidly gaining acceptance in pediatric acute care. In Israel, HFNC is approved for domestic use. We aim to describe its indications, efficacy, parental satisfaction, and safety.

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

Modified high-flow nasal cannula for children with respiratory distress. [2022] High-flow nasal cannula (HFNC) is a noninvasive respiratory support that provides the optimum flow of an air-oxygen mixture. Several studies demonstrated its usefulness and good safety profile for treating pediatric respiratory distress patients. However, the cost of the commercial HFNC is high; therefore, the modified high-flow nasal cannula was developed.

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

[Use of high-flow nasal oxygen therapy after extubation]. [2022] The decision of extubation is difficult in ICUs because in case of reintubation mortality is particularly high. High-flow nasal cannula oxygen therapy (HFNC) and noninvasive ventilation (NIV) are two respiratory supports that help to improve oxygenation, to decrease work of breathing and to decrease the risk of reintubation in selected patients. In the ICU, HFNC seems effective in patient with mild hypoxemia at time of extubation (risk of reintubation20%). Patients older than 65 years, those with underlying chronic cardiac or respiratory disease, or with hypercapnia are patients at high-risk easily identified at time of extubation. The best oxygenation strategy for management of post-extubation respiratory failure is unknown. HFNC has never been assessed in this setting, and NIV may have deleterious effects in patients with post-extubation respiratory failure. In postoperative patients, standard oxygen is sufficient even after major planned surgery (risk of intubation

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] High-flow nasal cannula (HFNC) oxygen therapy was noninferior to noninvasive ventilation (NIV) for preventing reintubation in a heterogeneous population at high-risk for extubation failure. However, outcomes might differ in certain subgroups of patients. Thus, we aimed to determine whether NIV with active humidification is superior to HFNC in preventing reintubation in patients with ≥ 4 risk factors (very high risk for extubation failure).