Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556797
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-21
Brief Title:
Proof-of-concept Study on Dyspnea Analysis Via GapCO2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
How to Differentiate Congestive and Non-congestive Dyspnea in the Emergency Department Proof-of-concept Study on Microperfusion Analysis Via GapCO2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MicroDys
Brief Summary:
Patients presenting to the emergency department with acute dyspnea undergo arterial blood gas measurement and monitoring of transcutaneous capnography using the TCM5 monitor The aim of this study is to determine whether GapCO2 the difference between transcutaneous and arterial pCO2 PaCO2 - PtcCO2 is correlated with the congestive or non-congestive origin of dyspnea
Detailed Description:
Upon arrival at the emergency department patients are placed in the vital emergency reception area for monitoring An emergency physician will review the selection criteria and offer the patient participation The information sheet will be provided to the patient along with a copy of the non-opposition form in case of patient agreement
Before the introduction of any treatment a TC 92 sensor is placed on the earlobe or on the forehead if the earlobe is inaccessible connected to a Radiometer TCM5 monitor measuring SpO2 Massimo technology perfusion index and transcutaneous capnography PtcCO2
After a 5-minute equilibration period measurements were taken throughout the duration of patient management Standard diagnostic and therapeutic management will be provided according to the attending physicians prescription The attending physician wont consider PtcCO2 nor GapCO2 measurements in patient management
At the time of data analysis an adjudication committee comprising 2 emergency physicians from the inclusion service but not involved in patient care will review the complete medical records of patients to determine whether dyspnea was of congestive or non-congestive origin
Before the introduction of any treatment a TC 92 sensor is placed on the earlobe or on the forehead if the earlobe is inaccessible connected to a Radiometer TCM5 monitor measuring SpO2 Massimo technology perfusion index and transcutaneous capnography PtcCO2
After a 5-minute equilibration period measurements were taken throughout the duration of patient management Standard diagnostic and therapeutic management will be provided according to the attending physicians prescription The attending physician wont consider PtcCO2 nor GapCO2 measurements in patient management
At the time of data analysis an adjudication committee comprising 2 emergency physicians from the inclusion service but not involved in patient care will review the complete medical records of patients to determine whether dyspnea was of congestive or non-congestive origin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None