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

Surgery Clinical Trial

— TECTONICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923699
• Other study ID #: 201903026
• Secondary ID: R01NR017916
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 83410
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Perioperative/Postoperative Complications
• Postoperative Complications
• Surgery
• Surgery--Complications

Intervention

Device:
• Anesthesia Control Tower monitoring
Real time data will be monitored through the AlertWatch® system as well as the patient's EHR.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with clinically relevant adverse perioperative outcomes.	To assess clinically relevant adverse perioperative outcomes	30 days post-op
Secondary	Thirty-day postoperative mortality	Definition postoperative mortality provided by Johnson et al. 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
Secondary	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.	30 days post-op
Secondary	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
Secondary	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).	30 days post-op