AbClo abdominal binder's effects on breathing mechanics in ventilated patients with an open abdomen
Official title: Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics (AbClo-Resp)
Run by Unity Health Toronto · NCT07154589 · Data updated 2026-11-12
This test will see if adjusting the AbClo abdominal binder changes lung pressures, lung volume, and breathing function in adults on ventilators with an open abdomen.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | June 10, 2025 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07154589 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) in the ICU with a postoperative open abdomen who are intubated, mechanically ventilated, sedated (RASS 1-3), and already being treated with the AbClo device are the ideal candidates.
✕Probably not a fit
Patients with contraindications to esophageal balloon placement, bronchopleural fistula, severe hemodynamic instability, uncontrolled intracranial pressure, or severe bleeding diathesis are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study enrolls adult ICU patients who already have an open abdomen and are being treated with the AbClo abdominal binding device while mechanically ventilated. Investigators will measure respiratory mechanics, including transpulmonary pressure, lung volumes, and oxygenation, before and after setting the AbClo device to the manufacturer's recommended pressure. The protocol also examines whether changes to the ventilator settings can reduce any negative effects linked to the binder. Data are collected at a single centre (St. Michael's Hospital, Toronto) from patients meeting the listed inclusion and exclusion criteria.
Why it matters
Potential benefit: If successful, the findings could help clinicians adjust abdominal binding and ventilator settings to reduce harmful effects on breathing and improve oxygenation in these ICU patients.
How similar studies have gone: Prior work has shown that external abdominal binding can alter respiratory mechanics, but using the AbClo device with detailed transpulmonary pressure measurements in open-abdomen ICU patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 18 years or older * Patients admitted to an ICU * Patients with postoperative abdominal surgery with open abdomen * Patients treated with AbClo device * Patients intubated and mechanically ventilated * Patients treated with intravenous sedation with a sedation-agitation scale score of 1-3 Exclusion Criteria: * Transient criteria: Patients with severe hemodynamic instability, defined systolic blood pressure less than 75 mmHg or mean arterial pressure less than 60 mmHg despite vasopressor use * Transient criteria: Patients with severe bleeding diathesis, defined as the latest platelet count less than 20 · 109/L, or the latest INR higher than 2.0 * Patients with concurrent injuries to upper gastrointestinal tract that would preclude esophageal balloon insertion * Patients with bronchopleural fistula * Patients with measured and uncontrolled increased intracranial pressure
Where it's running
-
St. Michael's Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Nattapat Wongtirawit, M.D.
- Email: nattapat.wongtirawit@unityhealth.to
- Phone: 416-864-6060
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Pulse Wave vs Saline Bolus EIT to measure lung perfusion in ARDS
This study tests whether pulse wave EIT or saline bolus EIT can best show lung blood flow in ARDS patients on mechanical ventilation.
-
Computed inspiratory muscle pressure to monitor inspiratory effort during pressure-targeted assist/control ventilation
This study tests a noninvasive computed pressure method (cPmus) to see if it matches the traditional esophageal pressure method for measuring inspiratory effort in adults on pressure-targeted ventilation with spontaneous breathing.
-
Noninvasive estimate of inspiratory effort to monitor pressure support ventilation
This study tests whether a noninvasive computed inspiratory muscle pressure (cPmus) can match the traditional esophageal pressure method for adults on pressure support ventilation.
-
Driving pressure-guided individualized PEEP vs standard PEEP during upper abdominal surgery
In this randomized trial, adults at higher risk of breathing problems after upper abdominal surgery will try a personalized PEEP level based on the lowest driving pressure and compare it to a fixed PEEP of 5 cmH2O to see if it lowers postoperative lung complications.
-
Inspiratory Effort and Dyspnea During Assisted Mechanical Ventilation in Critically Ill Adults
This study tests how different patient breathing efforts relate to breathlessness in adults on assisted mechanical ventilation.
-
FCV vs VC—Obese Adults Undergoing Laparoscopic Surgery
In obese adults having laparoscopic surgery, researchers will see if flow-controlled ventilation (FCV) works better than volume-controlled ventilation with autoflow (VC-AF) at keeping airway pressures and lung energy lower.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.