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Transpulmonary Pressure-Guided Ventilation Weaning for Obesity-Related Respiratory Issues
N/A
Recruiting
Research Sponsored by University of Mississippi Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is obese class II or higher (BMI greater than or equal to 35.0 kg/m2)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial will test if measuring chest/abdominal pressure can reduce time on ventilator, reducing risk of complications.
Who is the study for?
This trial is for obese patients (BMI ≥ 35.0 kg/m²) who have been on a ventilator for less than 48 hours due to respiratory failure. It's not suitable for those with esophageal or gastrointestinal issues, low platelet counts, neuromuscular diseases, difficult airways, life expectancy under 48 hours, prior chronic ventilation needs, severe neurological injuries or known pleural diseases.Check my eligibility
What is being tested?
The study tests if using transpulmonary pressure to guide ventilation weaning in obese patients can reduce time spent on mechanical ventilation and prevent complications like infections and weakness compared to standard methods.See study design
What are the potential side effects?
Potential side effects may include discomfort from the esophageal balloon catheter used to measure transpulmonary pressure and risks associated with prolonged mechanical ventilation such as lung injury.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is 35 or higher, classifying me as class II obese or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ventilator free days
Secondary outcome measures
Days on invasive mechanical ventilation
Hospital length of stay
Intensive care unit length of stay
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Transpulmonary pressure guided positive end expiratory pressureExperimental Treatment1 Intervention
Patients in this group will have the positive end expiratory pressure on the ventilator set to a transpulmonary pressure of 0-2 cm H2O during ventilation and spontaneous breathing trials.
Group II: Standard positive end expiratory pressureActive Control1 Intervention
Patients in this groups will have the positive end expiratory pressure on the ventilator set by the clinician during ventilation and set to a standard positive end expiratory pressure of 5-8 cm H2O during spontaneous breathing trials.
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Who is running the clinical trial?
University of Mississippi Medical CenterLead Sponsor
174 Previous Clinical Trials
195,259 Total Patients Enrolled
9 Trials studying Obesity
451 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a breathing machine for less than 2 days due to breathing failure.My BMI is 35 or higher, classifying me as class II obese or higher.I cannot have an esophageal balloon catheter due to certain health issues.You have a disease that affects your muscles and nerves.You have a known problem with your airway that makes it hard to breathe.The patient is not expected to live for more than 48 hours.I need a machine to help me breathe all the time.You have a serious brain or nerve injury.I have a known lung-related condition like persistent air leak, fluid around lungs, or pleurodesis.
Research Study Groups:
This trial has the following groups:- Group 1: Standard positive end expiratory pressure
- Group 2: Transpulmonary pressure guided positive end expiratory pressure
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.
To what extent has this clinical trial enrolled participants?
"Affirmative. Clinicaltrials.gov has verified that this trial, first launched on April 11th 2022, is actively recruiting patients for participation. A total of 128 people need to be enrolled at a single site."
Answered by AI
Are healthcare providers currently accepting participants for this research project?
"Indeed, the details hosted on clinicaltrials.gov confirm that this medical trial is actively searching for participants. Its initial posting was on April 11th 2022 and it has been updated as recently as April 11th 2023. 128 patients need to be recruited from one location."
Answered by AI
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