Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310629
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-21
Brief Title:
Oxygenation Efficacy of Intrinseque Health Non-Rebreathing Mask IHNRM
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
Comparison of Oxygenation Efficacy of Intrinseque Health Non-Rebreathing Mask IHNRM vs High Flow Nasal Cannula HFNC
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Based on early bench-testing data and subsequent clinical case studies in the US 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 25 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
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 25 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None