Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06007495
NA

Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.

Sponsor: Fisher and Paykel Healthcare

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2024-05-06

Completion Date

2025-12

Last Updated

2025-03-14

Healthy Volunteers

No

Interventions

DEVICE

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

DEVICE

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

DEVICE

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

Locations (2)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

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

Québec, Quebec, Canada