MedPath

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

Phase 3
Completed
Conditions
Surgery--Complications
Perioperative/Postoperative Complications
Surgery
Interventions
Device: Anesthesia Control Tower monitoring
Registration Number
NCT03923699
Lead Sponsor
Washington University School of Medicine
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
79560
Inclusion Criteria
  • All patients 18 years or older undergoing surgery at Barnes Jewish Hospital in St. Louis, MO
Read More
Exclusion Criteria
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Anesthesia Control Tower monitoringAnesthesia Control Tower monitoringClinicians 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.
Primary Outcome Measures
NameTimeMethod
Number of Participants With Postoperative Respiratory Failure30 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.

Thirty-day Postoperative Mortality30 days post-op

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

Number of Participants With Postoperative Delirium7 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.

Number of Participants With Postoperative Acute Kidney Injury7 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 Outcome Measures
NameTimeMethod
Antibiotic Redosing1 day

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

Mean Arterial Pressure Management1 day

Percentage time during surgery with mean arterial pressure ≥ 60 mmHg

Measured Anesthetic Concentration1 day

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

Fresh Gas Flow Rates1 day

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

Temperature Management1 day

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

Mean Airway Pressure With Mechanical Ventilation1 day

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

Blood Glucose Management1 day

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

Trial Locations

Locations (1)

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

© Copyright 2025. All Rights Reserved by MedPath