Recruiting

Investigational Mask

Sponsor:

Fisher and Paykel Healthcare

Code:

NCT06007495

Conditions

Acute Hypercapnic Respiratory Failure

Acute Hypoxemic Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Investigational full-face mask with expiratory washout

Conventional full-face mask - single-limb

Conventional full-face mask - dual-limb

Study Details

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 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

Conditions

Acute Hypercapnic Respiratory Failure

Acute Hypoxemic Respiratory Failure

Study ID

NCT06007495

Start date

May 6, 2024

Status verified date

Sep, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single-limb non-invasive ventilation with expiratory washout

In a random order, 30 minute period of non-invasive ventilation using the investigational mask, a vented full-face mask with expiratory washout

active comparator: Single-limb non-invasive ventilation

In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT077 or equivalent)

active comparator: Dual-limb non-invasive ventilation

In a random order, 30 minute period of non-invasive ventilation with a conventional vented full-face mask (RT076 or equivalent)

Interventions

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

Primary outcome measure

  • Minute Ventilation [ Time Frame: Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement ]

Central Contacts and Locations

Central contacts

James Miller

+64273032944jamie.miller@fphcare.co.nz

Locations

Centre hospitalier de l&amp;#39;Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, 20094

Contacts

Dr. Charbonney

514 890-8000emmanuel.charbonney@umontreal.ca

Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

Recruiting

Quebec City, Quebec, Canada, 2712

Contacts

Dr. Lellouche

418-656-8711francois.lellouche@criucpq.ulaval.ca

More Information

Sponsor

Fisher and Paykel Healthcare

Last update posted

Mar 14, 2025

Last verified

Sep, 2024

Keywords

  • Non-invasive Ventilation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fisher and Paykel Healthcare on 2025-03-14.