Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04668807
Status:
UNKNOWN
Last Update Posted:
2020-12-16
First Post:
2020-11-05
Brief Title:
Technical Capabilities of the SMART ANGEL Intra-hospital System s Connected Medical Device CMD
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Assessment of the Technical Capabilities of the SMART ANGEL Intra-hospital System s Connected Medical Device CMD
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
NOT_YET_RECRUITING
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:
SMART-METRO
Brief Summary:
Post-operative mortality in case of scheduled surgery is 3 in France Lancet 2013 mainly due to cardiovascular or respiratory complications by decompensation of pre-existing pathologies
Complications due to the medical practice are the third cause of morbidityBMJ 2016 More than half are preventable and are mainly observed in surgical patients In conventional hospitalization excluding intensive care monitoring is done discontinuously for most of the patients which does not allow early diagnosis of a vital cardiovascular or respiratory failure
Diagnosis and late treatment do not allow good recovery The early identification of a vital failure by the continuous monitoring of three simple physiological parameters SpO2 heart rate and respiratory rate would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality
Complications due to the medical practice are the third cause of morbidityBMJ 2016 More than half are preventable and are mainly observed in surgical patients In conventional hospitalization excluding intensive care monitoring is done discontinuously for most of the patients which does not allow early diagnosis of a vital cardiovascular or respiratory failure
Diagnosis and late treatment do not allow good recovery The early identification of a vital failure by the continuous monitoring of three simple physiological parameters SpO2 heart rate and respiratory rate would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality
Detailed Description:
The challenge of this research is to transpose in an ordinary hospitalization unit the continuous monitoring of vital functions carried out in intensive care by the continuous measurement of simple parameters using a Connected Medical Device CMD
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A02197-50 | OTHER | N IDRCB | None |