Clinical trial 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
- The study wants to see if using an esophageal pressure sensor to set ventilator pressure is doable and how it affects breathing and outcomes. It also checks whether this method changes the amount of pressure used compared with standard care.
- Who it's for
- Adults with a body‑mass index of 30 or higher who are on an invasive ventilator for respiratory failure.
- What's involved
- Participants are randomly assigned to have their ventilator pressure set by an esophageal pressure catheter or to receive the usual ventilator settings. Researchers will monitor breathing mechanics and clinical data while patients are in the ICU.
- Time commitment
- The trial runs for the length of the ICU stay, with daily monitoring and data collection until the patient is discharged or the ventilator is removed.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Edmonton, Alberta, Canada; St. Albert, Alberta, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.