Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUnity Health Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult patients admitted the ICU with open abdomen treated with AbClo device, and undergoing mechanical ventilation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
18 Participants
are grouped into 1 trial groupGroup A: Abdominal fascial approximation device
Trial outcomes
Primary outcomes
1
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 abdomenSecondary outcomes
1
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 enrolment2
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 abdomen3
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 enrolmentSponsors and contacts
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Source ClinicalTrials.gov