An interventional study of CNAP in Acute Respiratory Distress Syndrome, sponsored by The Hospital for Sick Children. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Supportive care
The aim is to test a device for applying continuous negative abdominal pressure in patients with ARDS
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 severe cases) and this has not changed in the last 20 years.
Mechanical ventilation is the mainstay of management, and this assists the patient by increasing oxygenation and removal of carbon dioxide. Despite optimizing tidal volume, driving pressure and positive end-expiratory pressure (PEEP), patients with ARDS develop large areas of atelectasis and poor oxygenation. There are few additional ventilator approaches that have proven to be useful in preventing this type of injury.
A major aim of ventilator support is recruitment of atelectatic (i.e. de-airated) lung, but while this is supported by excellent rational and laboratory data, the conventional clinical approaches have not been associated with a demonstrable improvement in patient outcome. Most atelectasis in ARDS occurs in the dorsal (dependant, lower-most) lung regions, and these are near the diaphragm.
The main ways to recruit lung are to increase the airway distending pressure (but this over-expands and damages the already-aerated lung regions); or, to turn the patient into the prone position (but clinicians are reluctant to utilize this approach - despite evidence that it may increase survival).
Continuous Negative Abdominal Pressure (CNAP) aims to selectively recruit basal atelectatic areas of lung, while enabling the patient to remain in the supine (usual) position.
Exclusion Criteria:
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;
Patients with ARDS will be placed inside of a Continuous Negative Abdominal Pressure Device. Negative pressure will be applied to the abdomen as an adjunct to positive pressure ventilation
Device: CNAP
Application of CNAP in patients with ARDS
Hypotension (SAFETY)
Reduction in mean arterial pressure to less than 60 mmHg or by 15%
Time frame: 30 min
Oxygen Saturation (SAFETY
Reduction in oxygen saturation (SpO2) by 5% or more
Time frame: 30 min
Oxygenation (SAFETY)
Reduction in P-to-F ratio (PaO2/FiO2) by \>20%
Time frame: 30 min
Oxygenation (EFFICACY)
Increase in PaO2/FiO2 by \>20%
Time frame: 30 min
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Plan to share: Undecided — undecided
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
The Hospital for Sick Children