Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-30 @ 12:13 PM
Study NCT ID:
NCT06433934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery
Sponsor:
Northwestern Medicine
Organization:
Study Overview
Official Title:
Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The purpose of this study is to determine if the performance of a newly released oxygen mask is the same, better, or worse than previous mask version. We will measure the flow rate necessary to maintain the same oxygen saturation in adult patients using each mask.
Detailed Description:
Southmedic, Inc. has received approval to distribute a newly designed oxygen mask. The current design has been studied and the FiO2 delivered reported to be inconsistent. The purpose of this study is to determine if the performance is the same, better, or worse than current mask. We can evaluate performance by determining Liter flow required to maintain oxygen saturations that are within limits described in NM CDH oxygen protocol. We will measure the flow rate necessary to maintain the same saturation in adult patients using both the OxyMask and Oxy2Mask. The Oxymask has a flow device inside the mask that has been revised since implementation. The mask itself is otherwise unchanged. We intend to determine if the same amount of flow results in the same outcome.
This study will include adult patients that require supplemental oxygen and we do not believe the patients will report a difference between each mask. The only variance in care is mask version used, the oxygen protocol will remain the same.
This study will include adult patients that require supplemental oxygen and we do not believe the patients will report a difference between each mask. The only variance in care is mask version used, the oxygen protocol will remain the same.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: