Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 8:56 AM
Study NCT ID:
NCT03944967
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2019-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients
Sponsor:
St. Antonius Hospital
Organization:
Study Overview
Official Title:
Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients
Status:
COMPLETED
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:
AGEAWARE
Brief Summary:
A significant number of elderly patients experience a complication after cardiac surgery. This study aims to determine if postoperative remote monitoring of vital signs can be used to identify medicatie risk factors for vital sign deterioration in older cardiac surgery patients.
* Single center pilot study.
* 100 older patients undergoing cardiac surgery.
* Continuous remote monitoring of vital signs after ICU discharge
* Main study endpoint is vital sign deterioration.
* Single center pilot study.
* 100 older patients undergoing cardiac surgery.
* Continuous remote monitoring of vital signs after ICU discharge
* Main study endpoint is vital sign deterioration.
Detailed Description:
Cardiac surgery in elderly patients aims to improve functional capacity and overall survival but may also precipitate major morbidity and mortality. Despite major improvements in the safety of anesthesia and surgery a significant number of elderly patients experience a complication after cardiac surgery.
To determine if postoperative remote monitoring of vital signs can be used to identify medication risk factors for vital sign deterioration in older cardiac surgery patients..
* Single center pilot study.
* 100 older patients undergoing cardiac surgery.
* Continuous remote monitoring of vital signs starts after ICU discharge
* PR, RR and SpO2 will be continuously monitored in all patients.
* Patients and healthcare personnel are blinded for monitoring results.
* Main study endpoint is vital sign deterioration.
The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.
To determine if postoperative remote monitoring of vital signs can be used to identify medication risk factors for vital sign deterioration in older cardiac surgery patients..
* Single center pilot study.
* 100 older patients undergoing cardiac surgery.
* Continuous remote monitoring of vital signs starts after ICU discharge
* PR, RR and SpO2 will be continuously monitored in all patients.
* Patients and healthcare personnel are blinded for monitoring results.
* Main study endpoint is vital sign deterioration.
The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.
Study Oversight
Has Oversight DMC:
False
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?: