Status:
UNKNOWN
Continuous Negative Abdominal Pressure in ARDS (CNAP in ARDS)
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Unity Health Toronto
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The aim is to test a device for applying continuous negative abdominal pressure in patients with ARDS
Detailed Description
Adult respiratory distress syndrome (ARDS) is a serious pulmonary disease affecting adults and children. It has a high mortality and there is no specific therapy. The mortality is high (approx. 40% in...
Eligibility Criteria
Inclusion
- Patients ≧ 18 years old
- Patients with moderate to severe ARDS as per the Berlin definition (PaO2/FiO2 ≤200mmHg)
- Patients with absence of any significant cardiopulmonary disease
Exclusion
- Contraindication to CNAP
- a. open abdominal wounds or drainage tubes; b. Acute brain Injury with intracranial pressure \>30 mm Hg or cerebral perfusion pressure \<60 mmHg; c. Decompensated heart insufficiency or acute coronary syndrome; d. Major hemodynamic instability: Mean arterial pressure lower than 60 mm Hg despite adequate fluid resuscitation and two vasopressors or increase of vasopressor dose by 30% in the next 6 hours; f. Unstable spine, femur, or pelvic fractures; g. Pregnancy; h. Pneumothorax;
- Contraindication to EIT electrode placement: Burns, chest wall bandaging limiting electrode placement
- Severe liver insufficiency (Child-Pugh score \> 7) or fulminant hepatic failure
- Major respiratory acidosis or PaCO2 \> 60 mmHg
- Severe COPD (according to the GOLD criteria defined as severe = FEV1: 30-50% or very severe = FEV1 \< 30%)
- Clinical judgement of the attending physician
Key Trial Info
Start Date :
January 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03425318
Start Date
January 4 2019
End Date
December 1 2024
Last Update
April 13 2023
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8