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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06310629
• Other study ID #: CMUH112-REC3-163
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: May 21, 2025

Study information

• Verified date: March 2024
• Source: China Medical University Hospital
• Contact: Chih-Ching Yen, PhD
• Phone: +886422052121
• Email: 005210[@]tool.caaumed.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Based on early bench-testing data and subsequent clinical case studies in the U.S., "Intrinseque Health" non-rebreathing mask (IHNRM) has delivered virtual elimination of air entrainment and preferential delivery of all available oxygen first into the alveolar spaces by sequential opening of valves in its controller manifold, even at oxygen flow as low as 10 LPM, patient can attain high alveolar oxygen concentration of 75% or more-far higher than attainable with face mask or nasal cannula.

Numerous intubated patients emerging from the operating room require intensive critical care specialist supervision in order to transition to the regular care. This would enable higher patient turnover and more efficient utilization of hospital resources, if patient can be transited to the regular care earlier by using a device that supports high oxygenation. This will enable a faster, safe and smooth extubation in critical care, and earlier discharge from intensive care ward.

This study is anticipated to take only around 2.5 hour per patient to complete. Patients meeting the inclusion and exclusion criteria of this study are placed on IHNRM and monitored until steady state of SpO2 of 95% or higher on 7-10 LPM has been maintained for at least 2 hours, when they can be discharged from the post-anesthesia care unit (PACU) to the regular care ward.

The study is the parallel design study. 60 patients will be randomly selected to use the IHNRM, and 30 subjects will be placed on HFNC. Blood oxygen concentration (SpO2), respiratory rate, end tidal CO2 concentration (EtCO2), and vital sign will be recorded in the study. The endpoint of the study is to compare the effect after using between "IHNRM" and HFNC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 21, 2025
• Est. primary completion date: February 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency
• Respiratory Tract Diseases

Intervention

Device:
• High Flow Nasal Cannula
High Flow Nasal Cannula
• "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")
"Intrinseque Health" Non-Rebreathing Mask ("IHNRM")

Locations

Country	Name	City	State
Taiwan	Department of Internal Medicine, China Medical Univdersity Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reach SpO2 Criteria in Run-in	Time to attaining SpO2 is by 4 percentage points or more above the baseline SpO2 while on room air or =95% .	SpO2 will be recorded in every 5 minutes in Run-in phase up to 30 minutes
Primary	The percentage of subjects to reach SpO2 Criteria in maintenance	Comparing % of patients able to maintain target parameters for a continuous duration of 2 hours or more the time of continuous SpO2 reading of 4 points or more above the baseline SpO2 while on room air or SpO2 reading =95%	SpO2 will be recorded in every 30 minutes in maintenance phase up to 2 hours