NCT03923699

Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety

Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety - Randomized Pragmatic Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 79,560 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Medical errors account for thousands of potentially preventable deaths each year. With the annual increase of surgical cases there is a need for research into the potential utility of a telemedicine-based control center for the operating room to assess risk, diagnose negative patient trajectories, implement evidence-based practices, and improve outcomes.

Detailed description

This will be a single center, randomized, controlled, phase 3 pragmatic clinical trial. Forty-eight operating rooms will be randomized daily to receive support from the ACT or not. All adults (eighteen years and older) undergoing surgical procedures in these operating rooms will be included and followed until 30-days after their surgery. Clinicians in operating rooms randomized to 'intervention' will receive decision support from clinicians in the ACT. In operating rooms not randomized to receive decision support from the ACT, the current standard of anesthesia care will be delivered. The intention-to-treat principle will be followed for all analyses.

Conditions

• Surgery
• Surgery--Complications
• Perioperative/Postoperative Complications

Interventions

Type	Name	Description
DEVICE	Anesthesia Control Tower monitoring	Real time data will be monitored through the AlertWatch® system as well as the patient's EHR.

Timeline

• Start date: 2019-07-01
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2019-04-23
• Last updated: 2024-07-17
• Results posted: 2024-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study