An observational study in Open Abdomen and Mechanical Ventilation, sponsored by Unity Health Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Unity Health Toronto · Observational
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:
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.
Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients admitted the ICU with open abdomen treated with AbClo device, and undergoing mechanical ventilation
Exclusion Criteria:
All patients are already on the device before starting the study
Changes in End-expiratory Transpulmonary Pressure
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.
Time frame: On the day of enrolment and on the day of surgery to close the abdomen
Changes in Lung Volume
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.
Time frame: On the day of enrolment
Changes in oxygenation function
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.
Time frame: On the day of enrolment and on the day of surgery to close the abdomen
Response in End-expiratory Transpulmonary Pressure to PEEP Increase
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.
Time frame: On the day of enrolment
Plan to share: No — The datasets generated and/or analyzed during the current study will not be publicly available due participant confidentiality, according to the REB, but will be available from the corresponding author on reasonable request.
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