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

NCT03923699 | Completed Phase 3 Results DMC FDA Device

• 2 other identifiers: 201903026R01NR017916
• Study Type: interventional
• Target: 79,560
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Surgery--Complications; Perioperative/Postoperative Complications

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Temperature Management

  1 day

• Antibiotic Redosing

  1 day

• Mean Arterial Pressure Management

  1 day

• Mean Airway Pressure With Mechanical Ventilation

  1 day

• Blood Glucose Management

  1 day

Study Arms (2)

Standard of care arm

NO 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.

Anesthesia Control Tower monitoring

EXPERIMENTAL

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

Interventions

Anesthesia Control Tower monitoring DEVICE

Real time data will be monitored through the AlertWatch® system as well as the patient's EHR.

Anesthesia Control Tower monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

• King CR, Fritz BA, Gregory SH, Budelier TP, Ben Abdallah A, Kronzer A, Helsten DL, Torres B, McKinnon SL, Tripathi S, Abdelhack M, Goswami S, Montes de Oca A, Mehta D, Valdez MA, Karanikolas E, Higo O, Kerby P, Henrichs B, Wildes TS, Politi MC, Abraham J, Avidan MS, Kannampallil T; ACTFAST collaborator group. Effect of telemedicine support for intraoperative anaesthesia care on postoperative outcomes: the TECTONICS randomised clinical trial. Br J Anaesth. 2025 Mar;134(3):671-680. doi: 10.1016/j.bja.2024.11.017. Epub 2025 Jan 3.

  PMID: 39753404 DERIVED

• King CR, Fritz BA, Gregory SH, Budelier TP, Ben Abdallah A, Kronzer A, Helsten DL, Torres B, McKinnon SL, Tripathi S, Abdelhack M, Goswami S, de Oca AM, Mehta D, Valdez MA, Karanikolas E, Higo O, Kerby P, Henrichs B, Wildes TS, Politi MC, Abraham J, Avidan MS, Kannampallil T; ACTFAST collaborator group. Effect of Telemedicine Support for Intraoperative Anaesthesia Care on Postoperative Outcomes: The TECTONICS Randomised Clinical Trial. medRxiv [Preprint]. 2024 Nov 26:2024.05.21.24307593. doi: 10.1101/2024.05.21.24307593.

  PMID: 38826207 DERIVED

• Fritz B, King C, Chen Y, Kronzer A, Abraham J, Ben Abdallah A, Kannampallil T, Budelier T, Montes de Oca A, McKinnon S, Tellor Pennington B, Wildes T, Avidan M. Protocol for the perioperative outcome risk assessment with computer learning enhancement (Periop ORACLE) randomized study. F1000Res. 2022 Sep 29;11:653. doi: 10.12688/f1000research.122286.2. eCollection 2022.

  PMID: 37547785 DERIVED

• 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.

  PMID: 32201572 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Thomas Kannampallil
• Organization: Washington University School of Medicine

thomas.k@wustl.edu

(314) 273-7801

Study Officials

• Michael S Avidan, MBBCh

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Anesthesia practitioner un-blinded to intervention, subject blinded to intervention, data analyst blinded to intervention, ACT Clinicians un-blinded to intervention
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Parallel assignment

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: April 23, 2019
• Study Start: July 1, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: July 17, 2024
• Results First Posted: July 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)