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Continuous Negative Abdominal Pressure in ARDS (CNAP in ARDS) (CNAP in ARDS)

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ClinicalTrials.gov Identifier: NCT03425318
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : September 17, 2021
Sponsor:
Collaborator:
Unity Health Toronto
Information provided by (Responsible Party):
Felix Ratjen, The Hospital for Sick Children

Study Description
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Brief Summary:
The aim is to test a device for applying continuous negative abdominal pressure in patients with ARDS

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Device: CNAP Not Applicable

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Continuous Negative Abdominal Pressure in ARDS (CNAP in ARDS)
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm
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


Outcome Measures
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Primary Outcome Measures :
  1. Hypotension (SAFETY) [ Time Frame: 30 min ]
    Reduction in mean arterial pressure to less than 60 mmHg or by 15%

  2. Oxygen Saturation (SAFETY [ Time Frame: 30 min ]
    Reduction in oxygen saturation (SpO2) by 5% or more

  3. Oxygenation (SAFETY) [ Time Frame: 30 min ]
    Reduction in P-to-F ratio (PaO2/FiO2) by >20%


Secondary Outcome Measures :
  1. Oxygenation (EFFICACY) [ Time Frame: 30 min ]
    Increase in PaO2/FiO2 by >20%


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients ≧ 18 years old
  2. Patients with moderate to severe ARDS as per the Berlin definition (PaO2/FiO2 ≤200mmHg)
  3. Patients with absence of any significant cardiopulmonary disease

Exclusion Criteria:

  1. 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;

  2. Contraindication to EIT electrode placement: Burns, chest wall bandaging limiting electrode placement
  3. Severe liver insufficiency (Child-Pugh score > 7) or fulminant hepatic failure
  4. Major respiratory acidosis or PaCO2 > 60 mmHg
  5. Severe COPD (according to the GOLD criteria defined as severe = FEV1: 30-50% or very severe = FEV1 < 30%)
  6. Clinical judgement of the attending physician
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425318


Contacts
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Contact: Doreen Engelberts 416 813 8891 doreen.engelberts@sickkids.ca
Contact: Laurent Brochard, MD 416 864 5686 Laurent.Brochard@unityhealth.to

Locations
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Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Audery Kim       Audery.Kim@unityhealth.to   
Contact: Laurent Brochard, MD    416 864 5686    Laurent.Brochard@unityhealth.to   
Sponsors and Collaborators
The Hospital for Sick Children
Unity Health Toronto
Investigators
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Principal Investigator: Laurent Brochard, MD Unity Health Toronto
  Study Documents (Full-Text)

Documents provided by Felix Ratjen, The Hospital for Sick Children:
Study Protocol and Statistical Analysis Plan  [PDF] January 5, 2018

More Information
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Responsible Party: Felix Ratjen, Division Head Respiratory Medicine, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03425318    
Other Study ID Numbers: 1000060365
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury