Clinical trial NCT06310629: Oxygenation Efficacy of "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")
Official title: Comparison of Oxygenation Efficacy of "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") vs. High Flow Nasal Cannula (HFNC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Disease
Respiratory Distress Syndrome
Respiratory Failure
Keywords: SpO2、extubation、EtCO2
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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.

Primary outcomes:
measure: Time to reach SpO2 Criteria in Run-in
timeFrame: SpO2 will be recorded in every 5 minutes in Run-in phase up to 30 minutes
measure: The percentage of subjects to reach SpO2 Criteria in maintenance
timeFrame: SpO2 will be recorded in every 30 minutes in maintenance phase up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Department of Internal Medicine, China Medical Univdersity Hospital
Study officials:
affiliation: Professor
name: Chih-Ching Yen, PhD
role: PRINCIPAL_INVESTIGATOR
References: