Status:
RECRUITING
Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics
Lead Sponsor:
Unity Health Toronto
Conditions:
Open Abdomen
Mechanical Ventilation
Eligibility:
All Genders
18+ years
Brief Summary
Patients who underwent an abdominal surgery and had the abdomen remain open are called to have an "open abdomen". To limit the risk of further widening of their wounds, surgeons can use AbClo, which i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07154589
Start Date
June 10 2025
End Date
June 1 2026
Last Update
September 4 2025
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8