Esophageal Pressure-Guided PEEP for Obesity
(TAILOR-PEEP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to assist individuals with a high body mass index (BMI) who require a breathing machine. Researchers are testing whether adjusting the machine's settings using a special balloon in the esophagus, known as esophageal pressure-guided PEEP titration, improves breathing compared to standard methods. Suitable candidates for this trial have a BMI of 30 or more, are currently on a breathing machine, and are expected to need it for at least 48 hours. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in respiratory care.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the clinical team conducting the study.
What prior data suggests that this protocol is safe for patients with high BMI?
Research has shown that adjusting the pressure in breathing machines using esophageal pressure-guided PEEP is generally safe for patients. This technique is particularly beneficial for obese patients, as it can safely enhance their oxygen levels. It involves using a small balloon in the esophagus to determine the appropriate pressure during mechanical breathing support.
One study found that maintaining the pressure close to zero improved survival rates. Patients tolerated the treatment well, and no major safety issues emerged. The evidence suggests this method is a promising way to improve breathing without causing harm.12345Why are researchers excited about this trial?
The esophageal pressure-guided PEEP (Positive End-Expiratory Pressure) titration is unique because it uses an esophageal balloon catheter to optimize breathing support by measuring and adjusting the pressure in the lungs more precisely. This method offers a personalized approach by targeting specific pressure ranges to improve oxygenation, which could be beneficial for patients with obesity-related respiratory issues. Researchers are excited about this technique because it may provide better lung protection and improve outcomes compared to the standard PEEP management, which typically does not involve such precise pressure monitoring.
What evidence suggests that esophageal pressure-guided PEEP titration is effective for obesity?
This trial will compare esophageal pressure-guided PEEP titration with standard of care PEEP management. Research has shown that adjusting ventilator air pressure based on esophageal pressure can improve oxygen levels and ease breathing for obese patients. Studies have found that this method often enhances oxygenation and lung function compared to standard methods. By fine-tuning the pressure to meet the patient's lung needs, it can lead to better outcomes. In some cases, this approach has also been linked to lower death rates in patients with certain health scores. Overall, early findings suggest that this method could be more effective than traditional pressure management in helping patients breathe better.13567
Are You a Good Fit for This Trial?
This trial is for obese patients with a BMI of 30 kg/m2 or higher who are on mechanical ventilation due to respiratory impairment. It's designed to see if managing their breathing support using esophageal pressure measurements can help more than standard care.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either esophageal pressure-guided PEEP titration or standard care management
Follow-up
Participants are monitored for safety and effectiveness after treatment
Feasibility Assessment
Assessment of feasibility for conducting a larger definitive trial
What Are the Treatments Tested in This Trial?
Interventions
- Esophageal pressure-guided PEEP titration
Trial Overview
The study compares two ways to set the positive end-expiratory pressure (PEEP) in ventilated obese patients: one uses standard care guidelines, and the other adjusts PEEP based on esophageal pressure readings. The goal is to find out which method works best for lung function.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Esophageal balloon catheter placed within 4 hours of randomization. PEEP titrated to achieve end-expiratory transpulmonary pressure of 0-2 cmH2O (up to 8 cmH2O for P/F ratio \<200). PEEP adjusted in 2 cmH2O increments with 5-minute stabilization periods. Safety limits: transpulmonary driving pressure \<15 cmH2O, end-inspiratory transpulmonary pressure \<20 cmH2O. Reassessment twice daily (approximately 0800 and 2200). Catheter removed prior to extubation or at 28 days, whichever occurs first.
PEEP management according to current standard practice. For patients meeting ARDS criteria, PEEP titrated using the ARDSNet PEEP/FiO2 table. For non-ARDS patients, PEEP titrated per local practice to optimize oxygenation while monitoring hemodynamic tolerance and respiratory mechanics. No esophageal pressure monitoring.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Citations
Retrospective Review of Transpulmonary Pressure Guided ...
PL-guided PEEP titration in obese patients can be used to safely titrate PEEP and decrease DP, resulting in improved oxygenation. Keywords ...
Providing Optimal PEEP During Mechanical Ventilation for ...
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 ...
High PEEP extubation as guided by esophageal manometry
EM-guided PEEP titration typically results in the application of higher PEEP, which has been shown to improve oxygenation and respiratory system compliance ...
Effect of Esophageal Pressure–guided Positive End- ...
Pes- guided PEEP was associated with lower mortality among patients with APACHE-II less than the median value (hazard ratio, 0.43; 95% ...
Esophageal Pressure-Guided PEEP for Obesity ...
This trial is for obese patients with a BMI of 30 kg/m2 or higher who are on mechanical ventilation due to respiratory impairment. It's designed ...
Providing Optimal PEEP During Mechanical Ventilation for ...
addition, EPVent2, a study of esophageal balloon PEEP titration in patients with ARDS utilized the High PEEP table. Patients with moderate ...
Effect of Esophageal Pressure–guided Positive End ... - PMC
PEEP titrated to end-expiratory transpulmonary pressure closer to 0 cm H 2 O was associated with greater survival than more positive or negative values.
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