Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.
Fisher and Paykel Healthcare
32 participants
May 6, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria12
- 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%
Exclusion Criteria11
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
With cross-over in randomized order, mask worn for 30 minutes with prescribed single-limb non-invasive ventilation
With cross-over in randomized order, conventional mask such as RT077, worn for 30 minutes with prescribed single-limb non-invasive ventilation
With cross-over in randomized order, conventional mask such as RT076, worn for 30 minutes with prescribed dual-limb non-invasive ventilation
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06007495