Evaluating a new mask for non-invasive ventilation in respiratory failure

Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.

This study is testing a new type of mask for people with breathing problems to see if it helps them breathe better compared to standard masks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fisher and Paykel Healthcare (Industry-sponsored)
• Locations: 2 sites (Montreal, Quebec and 1 other locations)
• Trial ID: NCT06007495 on ClinicalTrials.gov

What this trial studies

This pilot randomized cross-over study aims to compare the effectiveness of a full-face mask with expiratory washout against conventional full-face masks in patients experiencing acute hypercapnic and hypoxemic respiratory failure. Participants already prescribed non-invasive ventilation (NIV) will be randomized to receive NIV with either the investigational mask, a conventional single-limb mask, or a dual-limb mask. The study will measure various respiratory parameters and dyspnea scores to assess the impact of the investigational mask on minute ventilation and overall respiratory function.

Who should consider this trial

Good fit: Ideal candidates include hospitalized patients with acute respiratory failure who are stabilized and tolerating non-invasive ventilation.

Not a fit: Patients who are indicated for intubation or cannot fit the investigational mask may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved non-invasive ventilation techniques, enhancing patient outcomes in respiratory failure.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving ventilation strategies, suggesting potential for success.

Eligibility 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

Where this trial is running

Montreal, Quebec and 1 other locations

• Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (Recruiting)
• Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) — Québec, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: James Miller

Conditions Acute Hypercapnic Respiratory Failure; Acute Hypoxemic Respiratory Failure; Non-invasive Ventilation