Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.

Launched by FISHER AND PAYKEL HEALTHCARE · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is looking into the effects of a new type of full-face mask designed for patients with serious breathing problems, specifically those experiencing high carbon dioxide levels (acute hypercapnic respiratory failure) or low oxygen levels (acute hypoxemic respiratory failure). The researchers want to see if this new mask, which has a special feature called "expiratory washout," can help patients breathe better compared to standard masks used in non-invasive ventilation (NIV), a therapy that helps patients breathe without needing a breathing tube.

To participate in the study, patients must be between the ages of 65 and 74 and should not need immediate intubation (a breathing tube). Eligible participants will already be on NIV and will try three different types of mask setups in a random order. Throughout the trial, they will be monitored to see how well they breathe with each mask. It's important to know that certain conditions, such as claustrophobia or severe confusion, would exclude someone from participating, as the study aims to ensure everyone's safety and comfort.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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%
• Exclusion Criteria:
• • 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