Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
NCT Number: NCT06133140
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.
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Notify Me18 year and older
All sexes
Observational
Cleveland, Ohio, 44195, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Unblinded postoperative GE Portrait monitoring
Other names: Unblinded group
Blinded postoperative GE Portrait monitoring
Other names: Blinded group
Time frame: 48 postoperative hours.
Area of oxygen saturation defined as SpO2 ≤85%.
Time frame: 48 postoperative hours.
Area of inadequate or excessive ventilation defined as respiratory rate ≤4/min or ≥30/min.
Time frame: 48 postoperative hours.
Area of inadequate or excessive heart rate defined as ≤40/min or ≥130/min.
Time frame: 48 postoperative hours.
Determine whether continuous ward saturation, ventilation, and pulse rate monitoring reduces substantive respiratory and cardiovascular interventions. Each intervention will be considered dichotomously (occurred or not), and together constitute a composite outcome:
The Cleveland Clinic
Other
Acronym: COSMOS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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