Respiratory FailurePhase 2TAILOR-PEEPNCT07359261
Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients
A Phase 2 study testing Esophageal pressure-guided PEEP titration in people with Respiratory Failure, run by University of Alberta at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Esophageal pressure-guided PEEP titration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Feb 2026to 1 Jan 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta
Fernando G Zampieri, MD, 780.492.9951, fzampier@ualberta.ca
- Recruiting
Sturgeon Community Hospital
St. Albert, Alberta
Oleksa Rewa, MD, 780.492.995, rewa@ualberta.ca
About this study
Official title: Transpulmonary Assessment for Individualized Lung Optimization in Patients Living With Obesity Research - Positive End-Expiratory Pressure
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. The primary objective focuses on establishing the feasibility of conducting a larger definitive trial, while secondary objectives examine differences in applied PEEP levels, respiratory mechanics, and clinical outcomes between groups. The intervention protocol targets end-expiratory transpulmonary pressure of 0-2 cmH2O.
- Conditions
- Respiratory Failure
- Being tested
- Esophageal pressure-guided PEEP titration, Standard care PEEP management
- Keywords
- PEEP, obesity, mechanical ventilation
- Medical subject headings
- Respiratory Insufficiency, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal pressure-guided PEEP titrationProcedure or surgery
Also called Transpulmonary pressure-guided PEEP titration, Pes-guided PEEP management
PEEP titration guided by transpulmonary pressure measurements using esophageal manometry. Esophageal balloon catheter inserted within 4 hours of randomization, positioned at 35-40 cm depth with position verified by cardiac oscillations and occlusion test. PEEP titrated in 2 cmH2O increments targeting end-expiratory transpulmonary pressure 0-2 cmH2O, with option to target up to 8 cmH2O for severe hypoxemia (P/F <200). Safety limits enforced: transpulmonary driving pressure <15 cmH2O, end-inspiratory transpulmonary pressure <20 cmH2O. Measurements performed twice daily. Catheter removed at extubation or day 28.
Standard care PEEP managementOther
PEEP management per institutional standard practice without esophageal pressure monitoring. For patients meeting ARDS criteria, PEEP titrated using ARDSNet low PEEP/FiO2 table. For non-ARDS patients, PEEP titrated to optimize oxygenation while monitoring hemodynamic tolerance and respiratory mechanics per treating clinician judgment.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal-balloon guided | Experimental | 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. Receives: Procedure: Esophageal pressure-guided PEEP titration |
| Standard of Care | Active comparator | 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. Receives: Other: Standard care PEEP management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting a definitive trial (composite)
Composite feasibility assessment including: (1) Recruitment rate (patients enrolled per month, target 1-1.5/month); (2) Successful esophageal catheter placement rate in intervention arm; (3) Protocol adherence (percentage of scheduled transpulmonary pressure measurements completed, compliance with PEEP titration algorithm); (4) Data completeness for average PEEP over 7 days.
Measured: 14 months
Secondary outcomes (7)
Average PEEP
Key secondary endpoint. Mean positive end-expiratory pressure during mechanical ventilation
Measured: 7 days
Driving Pressure
Difference in driving pressure between groups
Measured: 7 days
Partial oxygen pressure over inspired oxygen fraction ratio
P/F ratio
Measured: 7 days
Days alive and free of mechanical ventilation
Days alive and free of mechanical ventilation
Measured: Up to hospital discharge assessed up to 30 days
Days alive and outside the intensive care unit
Days alive and outside the intensive care unit
Measured: Up to hospital discharge assessed up to 30 days
Hospital Mortality
Hospital Mortality
Measured: Up to hospital discharge assessed up to 30 days
Hemodynamics Instability
Hemodynamics Instability during PEEP Titration defined as a new start of vasopressors at any dose or an increase in vasopressor dose by 20%
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start5 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359261
- Sponsor's protocol ID
- Pro00154874
- Acronym
- TAILOR-PEEP
- Status last verified
- Apr 2026
- First submitted
- 5 Jan 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes