Evaluating a new non-rebreathing mask for improving oxygenation in respiratory distress

Comparison of Oxygenation Efficacy of "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") vs. High Flow Nasal Cannula (HFNC)

This study is testing a new type of non-rebreathing mask to see if it can help hospitalized patients with breathing difficulties get better oxygen and leave intensive care sooner.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 3 Years and up
• Sex: All
• Sponsor: China Medical University Hospital (other)
• Locations: 1 site (Taichung)
• Trial ID: NCT06310629 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of the 'Intrinseque Health' non-rebreathing mask (IHNRM) in hospitalized patients experiencing moderate to severe respiratory distress. The IHNRM is designed to minimize air entrainment and maximize oxygen delivery to the alveoli, potentially allowing for higher oxygen concentrations even at lower flow rates. The goal is to facilitate smoother extubation and earlier discharge from intensive care by improving oxygenation in patients transitioning from intubation. The study will include patients who are able to breathe spontaneously and have specific oxygen saturation levels.

Who should consider this trial

Good fit: Ideal candidates are hospitalized patients aged 3 years and older with moderate to moderately severe respiratory distress and specific oxygen saturation levels.

Not a fit: Patients with severe mental state impairments, multi-organ failure, or other critical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could lead to faster recovery times and more efficient use of hospital resources for patients with respiratory distress.

How similar studies have performed: While this approach is based on promising early data, it is relatively novel and has not been extensively tested in large-scale studies.

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.

Where this trial is running

Taichung

• Department of Internal Medicine, China Medical Univdersity Hospital — Taichung, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Chih-Ching Yen, PhD — Professor
• Study coordinator: Chih-Ching Yen, PhD

Conditions: Respiratory Disease, Respiratory Distress Syndrome, Respiratory Failure, SpO2、extubation、EtCO2