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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment failure defined by use of rescue respiratory support for acute respiratory failure in the first 72 hours after planned extubation
Secondary outcome measures
Reintubation rate
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
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
163,251 Total Patients Enrolled
14 Trials studying Obesity
1,725 Patients Enrolled for Obesity
Hospital Civil de GuadalajaraOTHER
38 Previous Clinical Trials
8,170 Total Patients Enrolled
Ramandeep KaurPrincipal InvestigatorRush University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am considering or have decided on a compassionate extubation.I or my family have not requested to be put back on a breathing machine.My medical team plans to remove my breathing tube.I am on a breathing machine due to a brain condition or to protect my airway.I use a machine to help with my breathing at home due to chronic respiratory failure.I have been on a breathing machine for at least 24 hours.I am 18 years old or older.I am on a breathing machine due to a severe COPD flare-up.My doctor says I must or must not use certain breathing support devices.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group (HFNC alone)
- Group 2: Intervention Group (NIV with HFNC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrollment opportunities for this clinical trial?
"As per records on clinicaltrials.gov, this research project is no longer actively recruiting participants; the initial posting date was July 1st 2023 and it last received an update on June 23rd 2023. Nevertheless, there are 104 other trials currently looking for volunteers."
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