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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNAP | Device | Application of CNAP in patients with ARDS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension (SAFETY) | Reduction in mean arterial pressure to less than 60 mmHg or by 15% | 30 min |
| Oxygen Saturation (SAFETY | Reduction in oxygen saturation (SpO2) by 5% or more | 30 min |
| Oxygenation (SAFETY) | Reduction in P-to-F ratio (PaO2/FiO2) by >20% | 30 min |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation (EFFICACY) | Increase in PaO2/FiO2 by >20% | 30 min |
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Inclusion Criteria:
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;
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doreen Engelberts | Contact | 416 813 8891 | doreen.engelberts@sickkids.ca | |
| Laurent Brochard, MD | Contact | 416 864 5686 | Laurent.Brochard@unityhealth.to |
| Name | Affiliation | Role |
|---|---|---|
| Laurent Brochard, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
undecided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2018 | Feb 6, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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