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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

Must not have

Patient has contraindications to esophageal balloon catheter placement including esophageal, nasofacial, gastrointestinal abnormalities and platelets less than 10,000/microliter

Patient requires chronic mechanical ventilation prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My BMI is 35 or higher, classifying me as class II obese or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have an esophageal balloon catheter due to certain health issues.

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I need a machine to help me breathe all the time.

Select...

I have a known lung-related condition like persistent air leak, fluid around lungs, or pleurodesis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ventilator free days

Secondary study objectives

Days on invasive mechanical ventilation

Hospital length of stay

Intensive care unit length of stay

+4 more

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: 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.

0 / 4Eligibility criteria met