Key result
The TECTONICS trial is a study protocol designed to evaluate whether an anesthesiology control tower prevents adverse postoperative outcomes in 40,000 adult surgical patients.
Why the study?
Perioperative morbidity is a major public health priority, creating an opportunity to evaluate whether a telemedicine-based anesthesiology control center improves care and outcomes.
Does intraoperative telemedicine support from an Anesthesiology Control Tower reduce adverse postoperative outcomes in adults undergoing surgical procedures?
RCT (n=40,000)
Single-blind (patients and outcome assessors blinded)
1:1 cluster randomization by operating room
No
Does intraoperative telemedicine support from an Anesthesiology Control Tower reduce adverse postoperative outcomes in adults undergoing surgical procedures?
This study protocol outlines a large-scale pragmatic trial to determine if a telemedicine-based anesthesiology control tower can reduce adverse postoperative outcomes and improve perioperative care quality.
Protocol for large RCT of anesthesiology control tower; leaves open whether telemedicine reduces postoperative adverse events.
<ns3:p> <ns3:bold>Introduction:</ns3:bold> Perioperative morbidity is a public health priority, and surgical volume is increasing rapidly. With advances in technology, there is an opportunity to research the utility of a telemedicine-based control center for anesthesia clinicians that assess risk, diagnoses negative patient trajectories, and implements evidence-based practices. </ns3:p> <ns3:p> <ns3:bold>Objectives:</ns3:bold> The primary objective of this trial is to determine whether an anesthesiology control tower (ACT) prevents clinically relevant adverse postoperative outcomes including 30-day mortality, delirium, respiratory failure, and acute kidney injury. Secondary objectives are to determine whether the ACT improves perioperative quality of care metrics including management of temperature, mean arterial pressure, mean airway pressure with mechanical ventilation, blood glucose, anesthetic concentration, antibiotic redosing, and efficient fresh gas flow. </ns3:p> <ns3:p> <ns3:bold>Methods and analysis:</ns3:bold> We are conducting a single center, randomized, controlled, phase 3 pragmatic clinical trial. A total of 58 operating rooms are randomized daily to receive support from the ACT or not. All adults (eighteen years and older) undergoing surgical procedures in these operating rooms are included and followed until 30 days after their surgery. Clinicians in operating rooms randomized to ACT support receive decision support from clinicians in the ACT. In operating rooms randomized to no intervention, the current standard of anesthesia care is delivered. The intention-to-treat principle will be followed for all analyses. Differences between groups will be presented with 99% confidence intervals; p-values <0.005 will be reported as providing compelling evidence, and p-values between 0.05 and 0.005 will be reported as providing suggestive evidence. </ns3:p> <ns3:p> <ns3:bold>Registration:</ns3:bold> TECTONICS is registered on ClinicalTrials.gov, <ns3:ext-link xmlns:ns4="http://www.w3.org/1999/xlink" ext-link-type="uri" ns4:href="https://clinicaltrials.gov/ct2/show/NCT03923699"> <ns3:italic>NCT03923699</ns3:italic> </ns3:ext-link> ; registered on 23 April 2019. </ns3:p>
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King et al. (2019) conducted an RCT in Surgical procedures requiring anesthesia (n=40,000). Anesthesiology Control Tower (ACT) system vs. Usual care was evaluated on Adverse postoperative outcomes (30-day mortality, delirium, respiratory failure, acute kidney injury). The TECTONICS trial is a study protocol designed to evaluate whether an anesthesiology control tower prevents adverse postoperative outcomes in 40,000 adult surgical patients.
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