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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03923699
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : July 10, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Michael Avidan, 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.

Condition or disease Intervention/treatment Phase
Surgery Surgery--Complications Perioperative/Postoperative Complications Device: Anesthesia Control Tower monitoring Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Parallel assignment
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
Primary Purpose: Prevention
Official Title: Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety - Randomized Pragmatic Trial
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Arm Intervention/treatment
No Intervention: Standard of care arm
Operating rooms in the standard of care group will be monitored but, the ACT clinicians will not contact the operating room unless it is clinically necessary for patient safety purposes.
Experimental: Anesthesia Control Tower monitoring
Clinicians 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.
Device: Anesthesia Control Tower monitoring
Real time data will be monitored through the AlertWatch® system as well as the patient's EHR.




Primary Outcome Measures :
  1. Number of Participants with clinically relevant adverse perioperative outcomes. [ Time Frame: 30 days post-op ]
    To assess clinically relevant adverse perioperative outcomes


Secondary Outcome Measures :
  1. Thirty-day postoperative mortality [ Time Frame: 30 days post-op ]
    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.

  2. Postoperative delirium [ Time Frame: 30 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. 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. Postoperative acute kidney injury [ Time Frame: 30 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923699


Contacts
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Contact: Sherry McKinnon, BS 314-286-1768 smckinnon@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Sherry McKinnon, BS    314-286-1768    mckinnos@anest.wustl.edu   
Principal Investigator: Michael S. Avidan, MBBCh, FCASA         
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Michael S Avidan, MBBCh Washington University School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Avidan, Professor of Anesthesiology and Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03923699    
Other Study ID Numbers: 201903026
R01NR017916 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers as the data is collected under a waiver of informed consent and is also protected by a Certificate of Confidentiality from the NIH.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michael Avidan, Washington University School of Medicine:
Telemedicine
Anesthesia Control Tower
Machine Learning
Forecasting Algorithms
Decision Support
Randomized Controlled Trial
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs