Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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%

Locations
Other Locations
Canada
Centre hospitalier de l&amp;#39;Université de Montréal (CHUM)
RECRUITING
Montreal
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
RECRUITING
Quebec City
Contact Information
Primary
James Miller
jamie.miller@fphcare.co.nz
+64273032944
Time Frame
Start Date: 2024-05-06
Estimated Completion Date: 2025-02
Participants
Target number of participants: 32
Treatments
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)
Sponsors
Collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Centre hospitalier de l&#39;Université de Montréal (CHUM)
Leads: Fisher and Paykel Healthcare

This content was sourced from clinicaltrials.gov