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Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.

NCT06007495 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-03-14

No results posted yet for this 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

Conditions

  • Acute Hypercapnic Respiratory Failure
  • Acute Hypoxemic Respiratory Failure

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

Sponsors & Collaborators

  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    collaborator UNKNOWN

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-06
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06007495 on ClinicalTrials.gov