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Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.

Acute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory Failure

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

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation Criteria

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

Study Location

Centre hospitalier de l&amp;#39;Université de Montréal (CHUM)
Centre hospitalier de l&amp;#39;Université de Montréal (CHUM)
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Dr. Charbonney

[email protected]
514 890-8000
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Quebec City, Quebec
Canada

Contact Study Team

Primary Contact

Dr. Lellouche

[email protected]
418-656-8711
Study Sponsored By
Fisher and Paykel Healthcare
Participants Required
More Information
Study ID: NCT06007495