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

Washington University School of Medicine79,560 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

79,560

Conditions

Surgery Surgery--Complications Perioperative/Postoperative Complications

Interventions

Anesthesia Control Tower monitoringDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 7 days post-op

Secondary Outcomes

Temperature Management

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

Time frame: 1 day

Antibiotic Redosing

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

Data from ClinicalTrials.gov

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