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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CNAP
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Michael's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

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

Outcomes

Primary Outcome Measures

Hypotension (SAFETY)
Reduction in mean arterial pressure to less than 60 mmHg or by 15%
Oxygen Saturation (SAFETY
Reduction in oxygen saturation (SpO2) by 5% or more
Oxygenation (SAFETY)
Reduction in P-to-F ratio (PaO2/FiO2) by >20%

Secondary Outcome Measures

Oxygenation (EFFICACY)
Increase in PaO2/FiO2 by >20%

Full Information

First Posted
January 29, 2018
Last Updated
April 12, 2023
Sponsor
The Hospital for Sick Children
Collaborators
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03425318
Brief Title
Continuous Negative Abdominal Pressure in ARDS (CNAP in ARDS)
Acronym
CNAP in ARDS
Official Title
Continuous Negative Abdominal Pressure in ARDS (CNAP in ARDS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
CNAP
Intervention Description
Application of CNAP in patients with ARDS
Primary Outcome Measure Information:
Title
Hypotension (SAFETY)
Description
Reduction in mean arterial pressure to less than 60 mmHg or by 15%
Time Frame
30 min
Title
Oxygen Saturation (SAFETY
Description
Reduction in oxygen saturation (SpO2) by 5% or more
Time Frame
30 min
Title
Oxygenation (SAFETY)
Description
Reduction in P-to-F ratio (PaO2/FiO2) by >20%
Time Frame
30 min
Secondary Outcome Measure Information:
Title
Oxygenation (EFFICACY)
Description
Increase in PaO2/FiO2 by >20%
Time Frame
30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doreen Engelberts
Phone
416 813 8891
Email
doreen.engelberts@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Brochard, MD
Phone
416 864 5686
Email
Laurent.Brochard@unityhealth.to
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Brochard, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audery Kim
Email
Audery.Kim@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Laurent Brochard, MD
Phone
416 864 5686
Email
Laurent.Brochard@unityhealth.to

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided

Learn more about this trial

Continuous Negative Abdominal Pressure in ARDS (CNAP in ARDS)

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