Clinical trial NCT06133140: Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial
Official title: Continuous Ward Monitoring With the GE Portrait Mobile Monitoring Solution: the COSMOS Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications
Keywords: Postoperative
Anesthesia
Vital signs
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 856
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hypoxemia
timeFrame: 48 postoperative hours.
measure: Inadequate or excessive ventilation
timeFrame: 48 postoperative hours.
measure: Bradycardia and tachycardia
timeFrame: 48 postoperative hours.
Secondary outcomes:
measure: The fraction of patients who have a composite of interventions potentially related to postoperative vital sign abnormalities.
timeFrame: 48 postoperative hours.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: PRINCIPAL_INVESTIGATOR
References: