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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Surgery--Complications; Perioperative/Postoperative Complications
• Intervention / Treatment: Device: Anesthesia Control Tower monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 79560
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care arm; 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.
Experimental: Anesthesia Control Tower monitoring; 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.	Device: Anesthesia Control Tower monitoring; Real time data will be monitored through the AlertWatch® system as well as the patient's EHR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thirty-day Postoperative Mortality	This will include death of any cause occurring in or out of the hospital, within 30 days of the index surgery.	30 days post-op
Number of Participants With Postoperative Delirium	Defined as an acute change in consciousness or cognition. It has a fluctuating course, and is characterized by inattention, disorganized thinking and altered level of consciousness. The institution has trained the nursing staff on our surgical intensive care units to assess all patients for postoperative delirium using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) instrument.	7 days post-op
Number of Participants With Postoperative Respiratory Failure	Defined as mechanical ventilation for greater than 24 hours after surgery, or unplanned postoperative re-intubation and mechanical ventilation within 30 days of surgery.	30 days post-op
Number of Participants With Postoperative Acute Kidney Injury	Diagnosed when any of the following three criteria are met: (i) an increase in serum creatinine by 50% compared with preoperative within 7 days, (ii) any increase in serum creatinine > 0.3 mg/dL in 48 hours, or (iii) oliguria (urine output <0.5 mL/kg/hr for 6-12 hours).	7 days post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature Management	Percentage of patients with Temperature ≥ 36°C at end of surgery.	1 day
Antibiotic Redosing	Percentage of patients with antibiotic redosing compliant with guidelines developed by the institutional pharmacy and therapeutics committee.	1 day
Mean Arterial Pressure Management	Percentage time during surgery with mean arterial pressure ≥ 60 mmHg	1 day
Mean Airway Pressure With Mechanical Ventilation	Percentage time during surgery with low PIP (peak inspiratory pressure)	1 day
Blood Glucose Management	Percentage of patients with blood glucose ≥ 200 mg/dL at end of surgery.	1 day
Measured Anesthetic Concentration	Percentage of patients without ≥ 15 consecutive min of anesthetic concentration ≤ 0.3 MAC during anesthetic maintenance period.	1 day
Fresh Gas Flow Rates	Percentage of patients with efficient fresh gas flow for ≥90% of the anesthetic maintenance period.	1 day

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Michael S Avidan, MBBCh, Washington University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: June 22, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Telemedicine; Decision Support; Randomized Controlled Trial; Machine Learning; Anesthesia Control Tower; Forecasting Algorithms
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 201903026; R01NR017916 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers as the data is collected under a waiver of informed consent and is also protected by a Certificate of Confidentiality from the NIH.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No