Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety - Randomized Pragmatic Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 79,560
- Locations
- 2
- Primary Endpoint
- Number of Participants With Postoperative Respiratory Failure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
Anesthesia practitioner un-blinded to intervention, subject blinded to intervention, data analyst blinded to intervention, ACT Clinicians un-blinded to intervention
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients 18 years or older undergoing surgery at Barnes Jewish Hospital in St. Louis, MO
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
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.
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.
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
- Antibiotic Redosing(1 day)
- Mean Arterial Pressure Management(1 day)
- Measured Anesthetic Concentration(1 day)
- Fresh Gas Flow Rates(1 day)
- Temperature Management(1 day)
- Mean Airway Pressure With Mechanical Ventilation(1 day)
- Blood Glucose Management(1 day)