Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety (TECTONICS)
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|ClinicalTrials.gov Identifier: NCT03923699|
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Surgery Surgery--Complications Perioperative/Postoperative Complications||Device: Anesthesia Control Tower monitoring||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Parallel assignment|
|Masking Description:||Anesthesia practitioner un-blinded to intervention, subject blinded to intervention, data analyst blinded to intervention, ACT Clinicians un-blinded to intervention|
|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|
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.
- Number of Participants with clinically relevant adverse perioperative outcomes. [ Time Frame: 30 days post-op ]To assess clinically relevant adverse perioperative outcomes
- 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.
- 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.
- 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.
- 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).
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
|Contact: Sherry McKinnon, BSfirstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Sherry McKinnon, BS 314-286-1768 email@example.com|
|Principal Investigator: Michael S. Avidan, MBBCh, FCASA|
|Principal Investigator:||Michael S Avidan, MBBCh||Washington University School of Medicine|