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New treatment option for Respiratory Failure
Official title Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients
ClinicalTrials.gov ID: NCT07359261
What this study is testing
- What it's testing
- This protocol describes a randomized controlled feasibility vanguard study designed to investigate the implementation and effects of esophageal pressure-guided positive end-expiratory pressure (PEEP) titration in patients with high body mass index (BMI) mechanically ventilated patients at the Edmonton Zone. The study will enroll 30 patients with body mass index (BMI) \>=30 kg/m2 who require invasive mechanical ventilation, randomizing them in a 1:1 ratio to receive either esophageal pressure-guided PEEP titration or standard care management.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older
- Body mass index ≥30 kg/m²
- Intubated and receiving passive mechanical ventilation
- Within 24 hours of intubation
- Anticipated need for mechanical ventilation for at least 48 hours
You likely can't join if
- Known or suspected esophageal varices
- Esophageal surgery within 3 months
- Known esophageal stricture or perforation
- Active upper gastrointestinal bleeding
- Severe coagulopathy (INR \>3.0 or platelet count \<30,000/μL)
- Known or suspected intracranial hypertension without intracranial pressure monitoring device demonstrating controlled intracranial pressure (\<20...
See the full eligibility criteria
- Age 18 years or older
- Body mass index ≥30 kg/m²
- Intubated and receiving passive mechanical ventilation
- Within 24 hours of intubation
- Anticipated need for mechanical ventilation for at least 48 hours
- Known or suspected esophageal varices
- Esophageal surgery within 3 months
- Known esophageal stricture or perforation
- Active upper gastrointestinal bleeding
- Severe coagulopathy (INR \>3.0 or platelet count \<30,000/μL)
- Known or suspected intracranial hypertension without intracranial pressure monitoring device demonstrating controlled intracranial pressure (\<20 mmHg)
- Severe hemodynamic instability at treating physician discretion
- Known pregnancy
- Moribund state with expected survival \<48 hours
- Receiving extracorporeal membrane oxygenation (ECMO)
- Open abdomen post-operatively
- Previous enrollment in this study
- Any other contraindication to esophageal balloon placement as determined by clinical team
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- St. Albert, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada; St. Albert, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.