Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133140
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2023-11-01
Brief Title:
Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution the COSMOS Trial
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution the COSMOS Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
COSMOS
Brief Summary:
The investigators plan to determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery
Detailed Description:
Primary Aim Determine whether unblinded continuous ward monitoring with the GE Portrait Mobile Monitoring Solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery
Primary hypothesis Unblinded continuous ward monitoring and nurse alerts reduces vital sign abnormalities during the initial 48 postoperative hours after major non-cardiac surgery while patients remain hospitalized
Secondary Aim Determine whether continuous ward saturation ventilation and pulse rate monitoring reduces a composite of substantive respiratory and cardiovascular interventions
Secondary hypothesis Unblinded continuous ward monitoring increases a composite of clinical interventions for desaturation hypoventilation tachypnea tachycardia and bradycardia within 48 hours after major non-cardiac surgery
Primary hypothesis Unblinded continuous ward monitoring and nurse alerts reduces vital sign abnormalities during the initial 48 postoperative hours after major non-cardiac surgery while patients remain hospitalized
Secondary Aim Determine whether continuous ward saturation ventilation and pulse rate monitoring reduces a composite of substantive respiratory and cardiovascular interventions
Secondary hypothesis Unblinded continuous ward monitoring increases a composite of clinical interventions for desaturation hypoventilation tachypnea tachycardia and bradycardia within 48 hours after major non-cardiac surgery
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?:
False
Is an FDA AA801 Violation?:
None