Phase 3 N=79,560 Randomized Single-blind Prevention

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

Surgery · Surgery--Complications · Perioperative/Postoperative Complications

Bottom Line

View on ClinicalTrials.gov: NCT03923699 ↗

Enrolled (actual)

79,560

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Thirty-day Postoperative Mortality — 899; 866 Participants — p=0.41

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Anesthesia Control Tower monitoring (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Thirty-day Postoperative Mortality	899; 866	0.41
PRIMARY Number of Participants With Postoperative Delirium	1506; 1502	0.92
PRIMARY Number of Participants With Postoperative Respiratory Failure	1301; 1282	0.68
PRIMARY Number of Participants With Postoperative Acute Kidney Injury	2784; 2736	0.42
SECONDARY Temperature Management	27101; 27398	0.99
SECONDARY Antibiotic Redosing	5520; 5629	0.95
SECONDARY Mean Arterial Pressure Management	0.96; 0.96	0.29
SECONDARY Mean Airway Pressure With Mechanical Ventilation	0.92; 0.92	0.37
SECONDARY Blood Glucose Management	1786; 1848	0.30
SECONDARY Measured Anesthetic Concentration	29851; 30087	0.85
SECONDARY Fresh Gas Flow Rates	19899; 19839	0.51

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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Data sourced from ClinicalTrials.gov (NCT03923699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.