Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-03-11 @ 9:09 PM
Study NCT ID:
NCT02707003
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2016-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Utility of Capnography in the PACU( Post-anaesthesia Care Unit)
Sponsor:
Medtronic - MITG
Organization:
Study Overview
Official Title:
A Multi-Center Pilot Observational Trial to Quantify the Potential Clinical Utility of Capnography in the PACU
Status:
COMPLETED
Status Verified Date:
2020-07
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:
Multi-center observational trial with study device blinded in order to assess in parallel standard monitoring and intervention practices related to management of respiratory compromise in the post-anaesthesia care unit (PACU)
Detailed Description:
All Study device information is blinded to medical staff but the Study Coordinator will have full access to device measurements, alarms, notification and events via a local Wi-Fi hub sent to a portable tablet. The tablet Case Report Form (CRF) will allow all observation be inserted with a time stamp on the electronic device data. In addition, all electronic data will be collected from the bedside monitor.
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: