Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinded monitoring | Continuous postoperative vital sign monitoring blinded to clinicians and investigators. |
| |
| Unblinded monitoring | Continuous postoperative vital sign monitoring unblinded to clinicians and investigators. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unblinded postoperative vital sign monitoring | Device | Unblinded postoperative GE Portrait monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxemia | Area of oxygen saturation defined as SpO2 ≤85%. | 48 postoperative hours. |
| Inadequate or excessive ventilation | Area of inadequate or excessive ventilation defined as respiratory rate ≤4/min or ≥30/min. | 48 postoperative hours. |
| Bradycardia and tachycardia | Area of inadequate or excessive heart rate defined as ≤40/min or ≥130/min. | 48 postoperative hours. |
| Measure | Description | Time Frame |
|---|---|---|
| The fraction of patients who have a composite of interventions potentially related to postoperative vital sign abnormalities. | 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:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who are older than 18 years of age. Patients have a ASA status 1-4. The patients whom had a major noncardiac surgery lasting at least 1.5 hours and are expected to remain hospitalized at least two postoperative nights, and are being admitted to a ward equipped with the GE Portrait Mobile Monitor.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ryu Komatsu, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
Data will be shared collaboratively upon approval of the Steering Committee and appropriate data-use agreement.
One year after publication of main paper.
Contact PI.
Not provided
Not provided
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Blinded postoperative vital sign monitoring | Device | Blinded postoperative GE Portrait monitoring |
|
|
| 48 postoperative hours. |