Continuous Negative Abdominal Pressure in ARDS (CNAP in ARDS) (CNAP in ARDS)
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|ClinicalTrials.gov Identifier: NCT03425318|
Recruitment Status : Not yet recruiting
First Posted : February 7, 2018
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome||Device: CNAP||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Continuous Negative Abdominal Pressure in ARDS (CNAP in ARDS)|
|Estimated Study Start Date :||March 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
|Experimental: Single arm||
Application of CNAP in patients with ARDS
- Hypotension (SAFETY) [ Time Frame: 30 min ]Reduction in mean arterial pressure to less than 60 mmHg or by 15%
- Oxygen Saturation (SAFETY [ Time Frame: 30 min ]Reduction in oxygen saturation (SpO2) by 5% or more
- Oxygenation (SAFETY) [ Time Frame: 30 min ]Reduction in P-to-F ratio (PaO2/FiO2) by >20%
- Oxygenation (EFFICACY) [ Time Frame: 30 min ]Increase in PaO2/FiO2 by >20%