Actively Recruiting
Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics
Led by Unity Health Toronto · Updated on 2026-04-22
18
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 is a non-invasive abdominal binding device, to keep the abdominal wall together (i.e., approximate the fascia). However, as the device also compresses on the abdomen and adjacent lungs, this study aims: * To assess whether the abdominal binding device causes changes in the pressure compressing the lungs, the lung volume, and the function of the lungs. * To assess whether adjusting the breathing machine can mitigate such negative changes. Participants will already be on the abdominal binding device when joining the study. Measurements on various aspects of the lung function (including its physical properties and capability to oxygenate the blood) will be done before and after adjustment of the abdominal binding device to the pressure (measured in the device itself) recommended by the manufacturer, as well as after the surgery to close the abdomen.
CONDITIONS
Official Title
Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patients with severe hemodynamic instability, defined as systolic blood pressure less than 75 mmHg or mean arterial pressure less than 60 mmHg despite vasopressor use
- Patients with severe bleeding diathesis, defined as platelet count less than 20 �b7 109/L, or INR higher than 2.0
- Patients with injuries to upper gastrointestinal tract that prevent esophageal balloon insertion
- Patients with bronchopleural fistula
- Patients with uncontrolled increased intracranial pressure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Actively Recruiting
Research Team
N
Nattapat Wongtirawit, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here