Oxygenation Efficacy of "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")

Launched by CHINA MEDICAL UNIVERSITY HOSPITAL · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of non-rebreathing mask called the "Intrinseque Health" Non-Rebreathing Mask (IHNRM). This mask is designed to help patients with respiratory issues, like respiratory failure or distress, breathe better by delivering more oxygen directly to the lungs. The goal is to see if using this mask can help patients maintain a good level of oxygen in their blood, allowing them to transition from intensive care to regular care more quickly and safely.

To participate in this trial, patients need to be hospitalized and experiencing moderate to severe breathing difficulties. They should be at least 3 years old and weigh at least 15 kg. Participants will wear the IHNRM for about 2.5 hours while their oxygen levels and other important health markers are monitored. The study will compare the effects of the IHNRM with another oxygen delivery method called High-Flow Nasal Cannula (HFNC). This research could help improve care for patients who need extra support while recovering from surgery or severe respiratory conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. ANY hospitalized patient in moderate to moderately severe respiratory distress and able to breathe spontaneously, and with SpO2 (oxygen saturation by pulse oximetry) reading of:
• • (i) 90% or less on room air, or (ii) \<95% in spite of oxygen supplementation on another form of oxygen supplementation.
• • 2. Has minimum ideal body wt. of at least ≥15 kg., and at least 3 years old.
• • 3. Self/guardian-able to consent to study participation and monitoring.
• Exclusion Criteria:
• Patient with any of the following present will be excluded:
• • 1. Agitated or confused or somnolent mental state.
• • 2. Any impairment of gag reflex.
• • 3. Multi-organ failure that may decompensate rapidly, with or without hypoperfusion secondary to cardiogenic, hypovolemic, or septic shock.
• • 4. Acute MI, pulmonary embolism, pneumothorax or stroke
• • 5. Inability to pull mask off (or to side of) face in emergency.
• • 6. ICP (intracranial pressure) \> 15mmhg. If ICP unknown but clinically may have elevated ICP (such as head trauma or CNS tumor), patient should be excluded.