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

March 7, 2024 updated by: China Medical University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Recruiting
        • Department of Internal Medicine, China Medical Univdersity Hospital
        • Contact:
        • Principal Investigator:
          • Chih-Ching Yen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Flow Nasal Cannula
Device: High Flow Nasal Cannula
High Flow Nasal Cannula
Experimental: "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")
Device: "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")
"Intrinseque Health" Non-Rebreathing Mask ("IHNRM")

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach SpO2 Criteria in Run-in
Time Frame: SpO2 will be recorded in every 5 minutes in Run-in phase up to 30 minutes
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
The percentage of subjects to reach SpO2 Criteria in maintenance
Time Frame: SpO2 will be recorded in every 30 minutes in maintenance phase up to 2 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Chih-Ching Yen, PhD, professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2024

Primary Completion (Estimated)

February 21, 2025

Study Completion (Estimated)

May 21, 2025

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH112-REC3-163

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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