Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.

NCT06007495 | Recruiting

• 1 other identifier: CIP_336
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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

Keywords

Non-invasive Ventilation

Outcome Measures

Primary Outcomes (1)

• Minute Ventilation

  Variations of the minute ventilation in the three different arms (Investigational mask, single-limb conventional, dual-limb conventional)

  Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement

Secondary Outcomes (5)

• Tidal Volume

  Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement

• Respiratory Rate

  Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement

• Blood gases

  Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement

• Dyspnoea Score

  Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement

• Mask Comfort Score

  Recorded at baseline and the end of each 30-minute period of non-invasive ventilation over 1 hour and 30 minutes of data measurement

Study Arms (3)

Single-limb non-invasive ventilation with expiratory washout

EXPERIMENTAL

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

Device: Investigational full-face mask with expiratory washout

Single-limb non-invasive ventilation

ACTIVE COMPARATOR

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

Device: Conventional full-face mask - single-limb

Dual-limb non-invasive ventilation

ACTIVE COMPARATOR

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

Device: Conventional full-face mask - dual-limb

Interventions

Investigational full-face mask with expiratory washout DEVICE

With cross-over in randomized order, mask worn for 30 minutes with prescribed single-limb non-invasive ventilation

Single-limb non-invasive ventilation with expiratory washout

Conventional full-face mask - single-limb DEVICE

With cross-over in randomized order, conventional mask such as RT077, worn for 30 minutes with prescribed single-limb non-invasive ventilation

Also known as: RT077

Single-limb non-invasive ventilation

Conventional full-face mask - dual-limb DEVICE

With cross-over in randomized order, conventional mask such as RT076, worn for 30 minutes with prescribed dual-limb non-invasive ventilation

Also known as: RT076

Dual-limb non-invasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator
• Fisher and Paykel Healthcare: lead
• Centre hospitalier de l&#39;Université de Montréal (CHUM): collaborator

Study Sites (2)

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

Montreal, Quebec, 20094, Canada

RECRUITING

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

Québec, Quebec, 2712, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

James Miller

CONTACT

+64273032944; jamie.miller@fphcare.co.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Cross-Over study

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 23, 2023
• Study Start: May 6, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2024-09

Locations

CA (2)