Clinical trial NCT03923699: Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety
Official title: Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety - Randomized Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgery
Surgery--Complications
Perioperative/Postoperative Complications
Keywords: Telemedicine
Anesthesia Control Tower
Machine Learning
Forecasting Algorithms
Decision Support
Randomized Controlled Trial
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-04-23
Enrollment: 79560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Parallel assignment
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Thirty-day Postoperative Mortality
timeFrame: 30 days post-op
measure: Number of Participants With Postoperative Delirium
timeFrame: 7 days post-op
measure: Number of Participants With Postoperative Respiratory Failure
timeFrame: 30 days post-op
measure: Number of Participants With Postoperative Acute Kidney Injury
timeFrame: 7 days post-op
Secondary outcomes:
measure: Temperature Management
timeFrame: 1 day
measure: Antibiotic Redosing
timeFrame: 1 day
measure: Mean Arterial Pressure Management
timeFrame: 1 day
measure: Mean Airway Pressure With Mechanical Ventilation
timeFrame: 1 day
measure: Blood Glucose Management
timeFrame: 1 day
measure: Measured Anesthetic Concentration
timeFrame: 1 day
measure: Fresh Gas Flow Rates
timeFrame: 1 day
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michael S Avidan, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: King CR, Abraham J, Kannampallil TG, Fritz BA, Ben Abdallah A, Chen Y, Henrichs B, Politi M, Torres BA, Mickle A, Budelier TP, McKinnon S, Gregory S, Kheterpal S, Wildes T, Avidan MS; TECTONICS Research Group. Protocol for the Effectiveness of an Anesthesiology Control Tower System in Improving Perioperative Quality Metrics and Clinical Outcomes: the TECTONICS randomized, pragmatic trial. F1000Res. 2019 Nov 29;8:2032. doi: 10.12688/f1000research.21016.1. eCollection 2019.