Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.

Recruiting now · Not applicable

Conditions studied: Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure

In brief

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

Key facts

Study ID

NCT06007495

Run by

Fisher and Paykel Healthcare

People needed

32

Starts

2024-05-06

Expected to finish

2025-12-01

Last updated by the study team

2025-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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%

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

Where it is running

• Centre hospitalier de l&amp;#39;Université de Montréal (CHUM) — Montreal, Quebec, Canada (enrolling)
• Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) — Québec, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.