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Tailored PEEP with Esophageal Balloon for Ventilated Obese Patients (PROP OPEN Trial)
N/A
Waitlist Available
Led By Thomas Bice, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Acute respiratory failure requiring mechanical ventilation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during mechanical ventilation
Awards & highlights
PROP OPEN Trial Summary
This trialwill test if a tailored approach to PEEP can help patients get off ventilators faster.
Who is the study for?
This trial is for obese patients with a body mass index (BMI) of 40 or higher who are experiencing acute respiratory failure and require mechanical ventilation. It's not suitable for those dependent on ventilators long-term, unable to consent, with specific abdominal or chest conditions, expected to be extubated within a day, at risk of high brain pressure, or with issues that prevent esophageal balloon placement.Check my eligibility
What is being tested?
The study aims to see if using an esophageal balloon to measure chest pressure can help find the best level of PEEP (positive end-expiratory pressure) for each patient and reduce time spent on a ventilator. Participants will either receive usual care or have their PEEP adjusted based on readings from the esophageal balloon.See study design
What are the potential side effects?
Potential side effects may include discomfort from the catheter placed through the nose into the esophagus and risks associated with incorrect PEEP levels such as lung injury or breathing difficulties.
PROP OPEN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on a breathing machine due to severe breathing problems.
PROP OPEN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during mechanical ventilation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during mechanical ventilation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Ventilator-Free Days (VFD) by Day 28
Secondary outcome measures
Highest Richmond Agitation and Sedation Scale
Hospital Length of Stay
ICU Length of Stay
+4 morePROP OPEN Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Optimal PEEPExperimental Treatment3 Interventions
The waveforms of airway pressure (Paw), esophageal pressure (Pes), and transpulmonary pressure (Ptp) will be visualized on the ventilator. Ptp is obtained from Paw - Pes. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP). Measurements will be obtained daily and adjustments to PEEP will occur daily. PEEP will be reduced below Optimal PEEP in the setting of hemodynamic compromise (requiring increasing vasoactive medications for blood pressure support).
Group II: ARDSNet High PEEPActive Control3 Interventions
PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2. The investigators chose the High PEEP table based on the clinical suspicion that obese patients may require higher PEEP levels on average than non-obese patients to balance the additional pressure of their chest wall. In addition, EPVent2, a study of esophageal balloon PEEP titration in patients with ARDS utilized the High PEEP table. Patients with moderate and severe ARDS benefit from higher levels of PEEP.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,586 Total Patients Enrolled
2 Trials studying Respiratory Failure
3 Patients Enrolled for Respiratory Failure
East Carolina UniversityOTHER
107 Previous Clinical Trials
38,733 Total Patients Enrolled
Thomas Bice, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have an esophageal balloon due to certain health issues.I am expected to be taken off the ventilator within 24 hours.I might have or am known to have high pressure in my brain.You have a very high body mass index, which means you are extremely overweight.I am on a breathing machine due to severe breathing problems.I have a chest tube for a collapsed lung.You need a ventilator to breathe for a long time.I have been diagnosed with abdominal compartment syndrome.You have been on a breathing machine for more than 4 days.You are in prison.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Optimal PEEP
- Group 2: ARDSNet High PEEP
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants able to join this clinical experiment at present?
"Evidently, no more patients are being sought for this study. It was initially posted on March 31st 2021 and the last update to the trial's information occurred on November 30th 2022. Fortunately, there are over 300 other medical trials that presently require participants."
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