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

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The Washington University

Status and phase

Completed
Phase 3

Conditions

Perioperative/Postoperative Complications
Surgery
Surgery--Complications

Treatments

Device: Anesthesia Control Tower monitoring

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03923699
R01NR017916 (U.S. NIH Grant/Contract)
201903026

Details and patient eligibility

About

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.

Full 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.

Enrollment

79,560 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients 18 years or older undergoing surgery at Barnes Jewish Hospital in St. Louis, MO

Exclusion criteria

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

79,560 participants in 2 patient groups

Standard of care arm
No Intervention group
Description:
Operating rooms in the standard of care group will be monitored but, the ACT clinicians will not contact the operating room unless it is clinically necessary for patient safety purposes.
Anesthesia Control Tower monitoring
Experimental group
Description:
Clinicians in the Anesthesiology Control Tower will provide extra support for the anesthesiology team in the operating room using AlertWatch and integrating machine-learning forecasting algorithms for adverse outcomes.
Treatment:
Device: Anesthesia Control Tower monitoring

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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