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Completed

NCT Number: NCT03923699

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

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.

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Key information

Conditions

Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications Surgery--Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Anesthesia Control Tower monitoring

Device

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

Primary outcomes

  1. Thirty-day Postoperative Mortality

    Time frame: 30 days post-op

    This will include death of any cause occurring in or out of the hospital, within 30 days of the index surgery.

  2. Number of Participants With Postoperative Delirium

    Time frame: 7 days post-op

    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.

  3. Number of Participants With Postoperative Respiratory Failure

    Time frame: 30 days post-op

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

  4. Number of Participants With Postoperative Acute Kidney Injury

    Time frame: 7 days post-op

    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).

Secondary outcomes

  1. Temperature Management

    Time frame: 1 day

    Percentage of patients with Temperature ≥ 36°C at end of surgery.

  2. Antibiotic Redosing

    Time frame: 1 day

    Percentage of patients with antibiotic redosing compliant with guidelines developed by the institutional pharmacy and therapeutics committee.

  3. Mean Arterial Pressure Management

    Time frame: 1 day

    Percentage time during surgery with mean arterial pressure ≥ 60 mmHg

  4. Mean Airway Pressure With Mechanical Ventilation

    Time frame: 1 day

    Percentage time during surgery with low PIP (peak inspiratory pressure)

  5. Blood Glucose Management

    Time frame: 1 day

    Percentage of patients with blood glucose ≥ 200 mg/dL at end of surgery.

  6. Measured Anesthetic Concentration

    Time frame: 1 day

    Percentage of patients without ≥ 15 consecutive min of anesthetic concentration ≤ 0.3 MAC during anesthetic maintenance period.

  7. Fresh Gas Flow Rates

    Time frame: 1 day

    Percentage of patients with efficient fresh gas flow for ≥90% of the anesthetic maintenance period.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Acronym: TECTONICS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2019
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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