AbClo abdominal binder's effects on breathing mechanics in ventilated patients with an open abdomen
Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics (AbClo-Resp)
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 |
|---|---|
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07154589 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.