Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFisher and Paykel Healthcare
About this trial
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 criteria
Qualifiers
No indication of intubation upon evaluation by physician in the next 2 hours
Fits the investigational mask
Patients hospitalized with acute respiratory failure (ARF) stabilized and tolerating NIV or;
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
Disqualifiers
Refusal to participate in the study
Inability to provide informed consent
Infectious isolation
Facial deformity, burns or morphology that prevents adequate mask placement
Trial design
Treatments tested in this trial
- Investigational full-face mask with expiratory washout
- Conventional full-face mask - single-limb
- Conventional full-face mask - dual-limb
Treatment groups
32 Participants
are divided into 3 treatment groupsSponsors and collaborators
Fisher and Paykel Healthcare
Lead sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator
Source ClinicalTrials.gov