Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics

Recruiting

• Conditions: Open Abdomen; Mechanical Ventilation

• Registration Number: NCT07154589
• Lead Sponsor: Unity Health Toronto

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-10
• Status Verified: 2025-08
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in End-expiratory Transpulmonary Pressure	On the day of enrolment and on the day of surgery to close the abdomen	Calculated by the difference between airway pressure and the value measured by an esophageal catheter at the end of expiration. Measurements are made once before the adjustment of the fascial approximation device to the optimal pressure, after the adjustment, and again after the surgery to close the abdomen.

Secondary Outcome Measures

Name	Time	Method
Changes in Lung Volume	On the day of enrolment	Measured by a ventilator capable of measuring end-expiratory lung volume, using a breath-in-breath-out method. Measurements are made once before the adjustment of the fascial approximation device to the optimal pressure, and again after the adjustment.
Changes in oxygenation function	On the day of enrolment and on the day of surgery to close the abdomen	Determined by the partial pressure of oxygen and PaO₂/FiO₂ ratio from arterial blood gas. Measurements are made once before the adjustment of the fascial approximation device to the optimal pressure, after the adjustment, and again after the surgery to close the abdomen.
Response in End-expiratory Transpulmonary Pressure to PEEP Increase	On the day of enrolment	In participants with negative end-expiratory transpulmonary pressure with clinically set PEEP, under the supervision of the clinical team in the ICU, PEEP will be titrated up until until zero or positive values are restored. Responses to the titration will be recorded.

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada