Status:
RECRUITING
Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.
Lead Sponsor:
Fisher and Paykel Healthcare
Collaborating Sponsors:
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Acute Hypercapnic Respiratory Failure
Acute Hypoxemic Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this pilot randomized cross-over study is to compare the effect of a full-face mask with expiratory washout to a conventional full face mask on non-invasive ventilation (NIV) in patients w...
Detailed Description
The investigational mask has been designed to deliver non-invasive ventilation (NIV) therapy with expiratory washout. Expiratory washout is a technique designed to flush the upper airway of carbon di...
Eligibility Criteria
Inclusion
- No indication of intubation upon evaluation by physician in the next 2 hours
- Fits the investigational mask
- Specific for hypercapnic patients 1 of the following criteria
- Patients hospitalized with acute respiratory failure (ARF) stabilized and tolerating NIV or;
- Patient admitted to hospital with ARF with one criteria for NIV among the following:
- Acute hypercapnic respiratory failure with hypercapnia and acidosis (Partial pressure of arterial carbon dioxide (PaCO2) \> 45 millimeters of mercury (mmHg) and pH \< 7.38) or
- Post-extubation period within 48 hours, in patients with high risk of re-intubation
- Specific for hypoxemic patients
- 1 of the following criteria
- Hypoxemic respiratory failure without hypercapnia requiring nasal high flow or;
- Hypoxemic respiratory failure without hypercapnia requiring NIV or;
- Conventional oxygen therapy (COT) \> 6 liters per minute (L/min) with peripheral oxygen saturation (SpO2) \< 92%
Exclusion
- Refusal to participate in the study
- Inability to provide informed consent
- Infectious isolation
- Facial deformity, burns or morphology that prevents adequate mask placement
- Claustrophobia
- Nausea
- Presence of nasogastric tube
- Pneumothorax
- Confusion or loss of consciousness
- Severe upper gastro-intestinal bleeding
- Any other condition, which at the investigators discretion, is believed may present a safety risk or impact the feasibility of the study or study results
Key Trial Info
Start Date :
May 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06007495
Start Date
May 6 2024
End Date
December 1 2025
Last Update
March 14 2025
Active Locations (2)
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1
Centre hospitalier de l&#39;Université de Montréal (CHUM)
Montreal, Quebec, Canada, 20094
2
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada, 2712