Actively Recruiting

Age: 18Years +
All Genders
ID07154589

Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics (AbClo-Resp)

Led by Unity Health Toronto · Updated on 2026-04-22

18

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to assess the effects of the AbClo abdominal binding device in patients who have undergone abdominal surgery and have an open abdomen. The study focuses on understanding how this device, which helps keep the abdominal wall together, might impact lung pressure, lung volume, and lung function. It also evaluates whether adjusting the breathing machine settings can reduce any negative effects caused by the device's pressure on the lungs. Participants are already using the AbClo device when they join the study. The study involves measuring various aspects of lung function, including physical properties and oxygenation ability, before and after adjusting the device's pressure to the manufacturer's recommended levels. These measurements are taken both on the day of enrollment and on the day of surgery to close the abdomen. During the study, participants will undergo assessments of lung function and pressure changes using the device. Researchers will monitor changes in end-expiratory transpulmonary pressure, lung volume, and oxygenation. The study includes evaluations at enrollment and at surgery closure, with the goal of understanding how the device and its adjustments affect respiratory mechanics in these patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Patients with severe hemodynamic instability (systolic blood pressure < 75 mmHg or mean arterial pressure < 60 mmHg despite vasopressors)
  • Patients with severe bleeding diathesis (platelet count < 20 �b7 10^9/L or INR > 2.0)
  • Patients with injuries to upper gastrointestinal tract preventing 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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Observational Assessment

Duration - From enrollment day to the day of surgery to close the abdomen

Participants who are already treated with the AbClo device are observed to assess respiratory mechanics and related outcomes.

2 visits (on the day of enrollment and on the day of surgery)

Trial Site Locations

Total: 1 location

1

St. Michael's Hospital

Toronto, Ontario, Canada, M5B1W8

Actively Recruiting

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Research Team

N

Nattapat Wongtirawit, M.D.

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

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Frequently Asked Questions

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Published Research Related To This Trial

Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial.

Jeremy R Beitler, Todd Sarge, Valerie M Banner-Goodspeed...

https://pubmed.ncbi.nlm.nih.gov/30776290

Early placement of a non-invasive, pressure-regulated, fascial reapproximation device improves reduction of the fascial gap in open abdomens: a retrospective cohort study.

Asad Naveed, Niels D Martin, Mohammed Bawazeer...

https://pubmed.ncbi.nlm.nih.gov/39411009

New non-invasive device to promote primary closure of the fascia and prevent loss of domain in the open abdomen: a pilot study.

Joao Baptista Rezende-Neto, Bruna Gewehr Camilotti

https://pubmed.ncbi.nlm.nih.gov/33225070

The open abdomen in trauma, acute care, and vascular and endovascular surgery: comprehensive, expert, narrative review.

Derek J Roberts, Ari Leppäniemi, Matti Tolonen...

https://pubmed.ncbi.nlm.nih.gov/37882630

Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome.

Andrew W Kirkpatrick, Derek J Roberts, Jan De Waele...

https://pubmed.ncbi.nlm.nih.gov/23673399