Recruiting

CNAP

Sponsor:

The Hospital for Sick Children

Code:

NCT03425318

Conditions

Acute Respiratory Distress Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CNAP

Study Details

Brief summary:

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

Conditions

Acute Respiratory Distress Syndrome

Study ID

NCT03425318

Start date

Jan 4, 2019

Status verified date

Apr, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

CNAP

Application of CNAP in patients with ARDS

Primary outcome measure

  • Hypotension (SAFETY) [ Time Frame: 30 min ]
  • Oxygen Saturation (SAFETY [ Time Frame: 30 min ]
  • Oxygenation (SAFETY) [ Time Frame: 30 min ]

Central Contacts and Locations

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Apr 13, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2023-04-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.