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Not recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT06133140

Conditions

Postoperative Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Unblinded postoperative vital sign monitoring

Blinded postoperative vital sign monitoring

Study Details

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.

Conditions

Postoperative Complications

Study ID

NCT06133140

Start date

Feb 14, 2024

Status verified date

Aug, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

856 participants

Anticipated

Interventions and Outcome Measures

Arms

Blinded monitoring

Continuous postoperative vital sign monitoring blinded to clinicians and investigators.

Unblinded monitoring

Continuous postoperative vital sign monitoring unblinded to clinicians and investigators.

Interventions

Unblinded postoperative vital sign monitoring

Unblinded postoperative GE Portrait monitoring

Blinded postoperative vital sign monitoring

Blinded postoperative GE Portrait monitoring

Primary outcome measure

  • Hypoxemia [ Time Frame: 48 postoperative hours. ]
  • Inadequate or excessive ventilation [ Time Frame: 48 postoperative hours. ]
  • Bradycardia and tachycardia [ Time Frame: 48 postoperative hours. ]

Central Contacts and Locations

Central contacts

Daniel I Sessler, MD

216-445-6500‬sessled@ccf.org

Lisa Humbert, MBA

‭(216) 213-7209‬HumberL@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Sandra Durbin

(216) 444-9950durbins3@ccf.org

Ross Waite

(216) 445-8386waiter3@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Aug 11, 2025

Last verified

Aug, 2025

Keywords

  • Postoperative
  • Anesthesia
  • Vital signs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-08-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.