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Noninvasive Ventilation for Extubation Failure in Obesity

N/A
Recruiting
Led By Ramandeep Kaur
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial will examine if noninvasive breathing support can reduce the risk of needing a tube back in to help with breathing for obese patients with higher BMI.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from wearing the mask or nasal device, skin irritation, dryness or bleeding in the nose, and possible difficulty sleeping due to equipment noise.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation
Secondary study objectives
Reintubation rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

Medical College of WisconsinOTHER
628 Previous Clinical Trials
1,179,626 Total Patients Enrolled
8 Trials studying Obesity
337 Patients Enrolled for Obesity
Rush University Medical CenterLead Sponsor
435 Previous Clinical Trials
249,044 Total Patients Enrolled
14 Trials studying Obesity
1,461 Patients Enrolled for Obesity
Hospital Civil de GuadalajaraOTHER
43 Previous Clinical Trials
8,984 Total Patients Enrolled
1 Trials studying Obesity
30 Patients Enrolled for Obesity

Media Library

Intervention Group (NIV with HFNC) Clinical Trial Eligibility Overview. Trial Name: NCT05918575 — N/A
Obesity Research Study Groups: Control Group (HFNC alone), Intervention Group (NIV with HFNC)
Obesity Clinical Trial 2023: Intervention Group (NIV with HFNC) Highlights & Side Effects. Trial Name: NCT05918575 — N/A
Intervention Group (NIV with HFNC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05918575 — N/A
~136 spots leftby Jul 2026
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