Continuous Negative Abdominal Pressure in ARDS (CNAP in ARDS)

NCT03425318 | Unknown

• 1 other identifier: 1000060365
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to test a device for applying continuous negative abdominal pressure in patients with ARDS

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Oxygenation (EFFICACY)

  30 min

Study Arms (1)

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

Device: CNAP

Interventions

CNAP DEVICE

Application of CNAP in patients with ARDS

Single arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Unity Health Toronto: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Laurent Brochard, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doreen Engelberts

CONTACT

416 813 8891; doreen.engelberts@sickkids.ca

Laurent Brochard, MD

CONTACT

416 864 5686; Laurent.Brochard@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head Respiratory Medicine

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 7, 2018
• Study Start: January 4, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

CA (1)