Investigational full-face mask with expiratory washout: With cross-over in randomized order, mask worn for 30 minutes with prescribed single-limb non-invasive ventilation
Conventional full-face mask - single-limb: With cross-over in randomized order, conventional mask such as RT077, worn for 30 minutes with prescribed single-limb non-invasive ventilation
Conventional full-face mask - dual-limb: With cross-over in randomized order, conventional mask such as RT076, worn for 30 minutes with prescribed dual-limb non-invasive ventilation
Study 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 with acute hypercapnic, and acute hypoxemic, respiratory failure. The main questions it aims to answer are:
* Does a mask with expiratory washout improve minute ventilation in patients using non-invasive ventilation compared with a conventional single-limb NIV mask
* How does a mask with expiratory washout affect respiratory variables compared with a dual-limb NIV mask.
Participants already prescribed NIV will undergo 3 arms of the investigation in a randomized order:
* Single-limb NIV with investigation mask (with expiratory washout)
* Single-limb NIV with conventional mask
* Dual-limb NIV with conventional mask
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Minute Ventilation — Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement Variations of the minute ventilation in the three different arms (Investigational mask, single-limb conventional, dual-limb conventional)
Trial sites (2)
Facility
City
Region
Status
Centre hospitalier de l&#39;Université de Montréal (CHUM)
Montreal
Quebec
Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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