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.

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.

Telemedicine, Anesthesia Control Tower, Machine Learning, Forecasting Algorithms, Decision Support, Randomized Controlled Trial

Anesthesia practitioner un-blinded to intervention, subject blinded to intervention, data analyst blinded to intervention, ACT Clinicians un-blinded to intervention

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.

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.

Definition postoperative mortality provided by Johnson et al. This will include death of any cause occurring in or out of the hospital, within 30 days of the index surgery.

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.

Defined as mechanical ventilation for greater than 24 hours after surgery, or unplanned postoperative re-intubation and mechanical ventilation within 30 days of surgery.

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).

Inclusion Criteria: All patients 18 years or older undergoing surgery at Barnes Jewish Hospital in St. Louis, MO Exclusion Criteria: -

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.

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.