Recruiting

AbClo

Sponsor:

Unity Health Toronto

Code:

NCT07154589

Conditions

Open Abdomen

Mechanical Ventilation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Open Abdomen

Mechanical Ventilation

Study ID

NCT07154589

Start date

Jun 10, 2025

Status verified date

Aug, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 ยท 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

Enrollment

18 participants

Anticipated

Interventions and Outcome Measures

Arms

Abdominal fascial approximation device

All patients are already on the device before starting the study

Primary outcome measure

  • Changes in End-expiratory Transpulmonary Pressure [ Time Frame: On the day of enrolment and on the day of surgery to close the abdomen ]

Central Contacts and Locations

Central contacts

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B1W8

Contacts

More Information

Sponsor

Unity Health Toronto

Last update posted

Apr 22, 2026

Last verified

Aug, 2025

Keywords

  • open abdomen
  • mechanical ventilation
  • transpulmonary pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-04-22.