Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial

NeuroTherapia, Inc.

Status: Completed

Conditions: Postoperative Complications

Treatments: Device: Blinded postoperative vital sign monitoring; Device: Unblinded postoperative vital sign monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT06133140

24-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Are expected to be admitted to one of the wards equipped with the GE Portrait Mobile Monitoring Solution;
2. Are ≥18 years old;
3. Are designated American Society of Anesthesiologists physical status 1-4;
4. Are scheduled for major noncardiac surgery lasting at least 1.5 hours;
5. Are expected to remain hospitalized at least one postoperative night;
6. Are expected to have general or neuraxial anesthesia.

Exclusion criteria

1. Have language, vision, or hearing impairments that might compromise continuous monitoring;
2. Are designated Do Not Resuscitate, hospice, or receiving end of life care;
3. Are expected to have telemetry monitoring;
4. Have previously participated in the study.

Trial design

227 participants in 2 patient groups

Blinded monitoring

Description:

Continuous postoperative vital sign monitoring blinded to clinicians and investigators.

Treatment:

Device: Blinded postoperative vital sign monitoring

Unblinded monitoring

Description:

Continuous postoperative vital sign monitoring unblinded to clinicians and investigators.

Treatment:

Device: Unblinded postoperative vital sign monitoring