Respiratory DiseaseNCT06310629
Oxygenation Efficacy of "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")
A study testing High Flow Nasal Cannula and "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") in people with Respiratory Disease and Respiratory Distress Syndrome, run by China Medical University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Respiratory Disease, Respiratory Distress Syndrome, Respiratory Failure
- What is being tested?
- High Flow Nasal Cannula and "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Feb 2024to 21 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- 90% or less on room air, or (ii) <95% in spite of oxygen supplementation on another form of oxygen supplementation.
- Has minimum ideal body wt. of at least ≥15 kg., and at least 3 years old.
- Self/guardian-able to consent to study participation and monitoring.
Who cannot join
- Patient with any of the following present will be excluded:
- Agitated or confused or somnolent mental state.
- Any impairment of gag reflex.
- Multi-organ failure that may decompensate rapidly, with or without hypoperfusion secondary to cardiogenic, hypovolemic, or septic shock.
- Acute MI, pulmonary embolism, pneumothorax or stroke
- Inability to pull mask off (or to side of) face in emergency.
- ICP (intracranial pressure) > 15mmhg. If ICP unknown but clinically may have elevated ICP (such as head trauma or CNS tumor), patient should be excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, China Medical Univdersity Hospital
Taichung
Chih-Chihng Yen, MD, PhD, 886-4-22052121 ext. 3483, d5210@mail.cmuh.org.tw
Chih-Ching Yen, MD, PhD
About this study
Official title: 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.
Read more
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.
- Being tested
- High Flow Nasal Cannula, "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")
- Keywords
- SpO2、extubation、EtCO2
- Medical subject headings
- Respiration Disorders, Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal CannulaDevice
High Flow Nasal Cannula
"Intrinseque Health" Non-Rebreathing Mask ("IHNRM")Device
"Intrinseque Health" Non-Rebreathing Mask ("IHNRM")
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula | Active comparator | High Flow Nasal Cannula Receives: Device: High Flow Nasal Cannula |
| "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") | Experimental | "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") Receives: Device: "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") |
What is being measured
The primary outcome is the main question the study is designed to answer.
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% .
Measured: 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
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%
Measured: SpO2 will be recorded in every 30 minutes in maintenance phase up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start22 Feb 2024
- Primary completion21 Feb 2025 (estimated)
- Study completion21 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Ching Yen, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310629
- Sponsor's protocol ID
- CMUH112-REC3-163
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxygenation Efficacy of "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") vs. High Flow Nasal Cannula (HFNC)
- ClinicalTrials.gov ID
- NCT06310629
- Acronym / sponsor ID
- CMUH112-REC3-163
- Keywords
- SpO2、extubation、EtCO2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 21 Feb 2025 (estimated)
- Study completion
- 21 May 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula | Active comparator | Device: High Flow Nasal CannulaHigh Flow Nasal Cannula |
| "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") | Experimental | Device: "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")"Intrinseque Health" Non-Rebreathing Mask ("IHNRM") |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
- Has minimum ideal body wt. of at least ≥15 kg., and at least 3 years old.
- Self/guardian-able to consent to study participation and monitoring.
Key exclusion criteria (7 listed)
- Agitated or confused or somnolent mental state.
- Any impairment of gag reflex.
- Multi-organ failure that may decompensate rapidly, with or without hypoperfusion secondary to cardiogenic, hypovolemic, or septic shock.
- Acute MI, pulmonary embolism, pneumothorax or stroke
- Inability to pull mask off (or to side of) face in emergency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow Nasal CannulaHigh Flow Nasal Cannula | Device | High Flow Nasal Cannula |
| "Intrinseque Health" Non-Rebreathing Mask ("IHNRM")"Intrinseque Health" Non-Rebreathing Mask ("IHNRM") | Device | "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") |
Primary outcome
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% .
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%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Ching Yen, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula and "Intrinseque Health" Non-Rebreathing Mask ("IHNRM") in people with Respiratory Disease and Respiratory Distress Syndrome, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Ching Yen, PhD (+886422052121, 005210@tool.caaumed.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.