Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147674
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-07-26
Brief Title:
Evaluation of VQm PHM on Pulmonary Health Parameters for ICU
Sponsor:
Rostrum Medical Innovations Inc
Organization:
Rostrum Medical Innovations Inc
Study Overview
Official Title:
Evaluation of VQm Pulmonary Health Monitor on Pulmonary Health Parameters for Intensive Care Medicine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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 goal of this observational study is to compare pulmonary health parameter measurements from the VQm PHM to existing clinical measurements The main questions it aims to answer are
Confirm the performance of non-invasive pulmonary health parameter shunt fraction value found on the VQm PHM when compared to available reference measurements
Confirm the performance of non-invasive pulmonary health parameter pulmonary blood flow functional residual capacity and physiological dead space found on the VQm PHM when compared to available reference measurements
Confirm the performance of non-invasive pulmonary health parameter shunt fraction value found on the VQm PHM when compared to available reference measurements
Confirm the performance of non-invasive pulmonary health parameter pulmonary blood flow functional residual capacity and physiological dead space found on the VQm PHM when compared to available reference measurements
Detailed Description:
This is a multi-site international prospective non-blinded non-randomized observational study This study aims to compare measurements from the VQm PHM to existing clinical measurements assess safety of the device and determine effects that standard clinical events have on the VQm PHM measurements This study does not include changes to clinical care based on measurements from the VQm PHM Each patient will serve as their own control
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?:
None
Is an FDA AA801 Violation?:
None