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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR017916 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care arm | No Intervention | 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. | |
| Anesthesia Control Tower monitoring | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anesthesia Control Tower monitoring | Device | Real time data will be monitored through the AlertWatch® system as well as the patient's EHR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thirty-day Postoperative Mortality | 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 |
| Number of Participants With 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. | 7 days post-op |
| Number of Participants With 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 |
| Number of Participants With 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). | 7 days post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature Management | Percentage of patients with Temperature ≥ 36°C at end of surgery. | 1 day |
| Antibiotic Redosing | Percentage of patients with antibiotic redosing compliant with guidelines developed by the institutional pharmacy and therapeutics committee. |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Avidan, MBBCh | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39753404 | Derived | King CR, Fritz BA, Gregory SH, Budelier TP, Ben Abdallah A, Kronzer A, Helsten DL, Torres B, McKinnon SL, Tripathi S, Abdelhack M, Goswami S, Montes de Oca A, Mehta D, Valdez MA, Karanikolas E, Higo O, Kerby P, Henrichs B, Wildes TS, Politi MC, Abraham J, Avidan MS, Kannampallil T; ACTFAST collaborator group. Effect of telemedicine support for intraoperative anaesthesia care on postoperative outcomes: the TECTONICS randomised clinical trial. Br J Anaesth. 2025 Mar;134(3):671-680. doi: 10.1016/j.bja.2024.11.017. Epub 2025 Jan 3. | |
| 38826207 |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. Anesthesia Control Tower monitoring: Real time data will be monitored through the AlertWatch® system as well as the patient's EHR. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Anesthesia Control Tower Monitoring |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Thirty-day Postoperative Mortality | This will include death of any cause occurring in or out of the hospital, within 30 days of the index surgery. | Posted | Count of Participants | Participants | 30 days post-op |
|
30 days post-op
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Kannampallil | Washington University School of Medicine | (314) 273-7801 | thomas.k@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 14, 2020 | Jan 31, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2023 | Jan 31, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized Parallel assignment
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Anesthesia practitioner un-blinded to intervention, subject blinded to intervention, data analyst blinded to intervention, ACT Clinicians un-blinded to intervention
| 1 day |
| Mean Arterial Pressure Management | Percentage time during surgery with mean arterial pressure ≥ 60 mmHg | 1 day |
| Mean Airway Pressure With Mechanical Ventilation | Percentage time during surgery with low PIP (peak inspiratory pressure) | 1 day |
| Blood Glucose Management | Percentage of patients with blood glucose ≥ 200 mg/dL at end of surgery. | 1 day |
| Measured Anesthetic Concentration | Percentage of patients without ≥ 15 consecutive min of anesthetic concentration ≤ 0.3 MAC during anesthetic maintenance period. | 1 day |
| Fresh Gas Flow Rates | Percentage of patients with efficient fresh gas flow for ≥90% of the anesthetic maintenance period. | 1 day |
| Derived |
| King CR, Fritz BA, Gregory SH, Budelier TP, Ben Abdallah A, Kronzer A, Helsten DL, Torres B, McKinnon SL, Tripathi S, Abdelhack M, Goswami S, de Oca AM, Mehta D, Valdez MA, Karanikolas E, Higo O, Kerby P, Henrichs B, Wildes TS, Politi MC, Abraham J, Avidan MS, Kannampallil T; ACTFAST collaborator group. Effect of Telemedicine Support for Intraoperative Anaesthesia Care on Postoperative Outcomes: The TECTONICS Randomised Clinical Trial. medRxiv [Preprint]. 2024 Nov 26:2024.05.21.24307593. doi: 10.1101/2024.05.21.24307593. |
| 37547785 | Derived | Fritz B, King C, Chen Y, Kronzer A, Abraham J, Ben Abdallah A, Kannampallil T, Budelier T, Montes de Oca A, McKinnon S, Tellor Pennington B, Wildes T, Avidan M. Protocol for the perioperative outcome risk assessment with computer learning enhancement (Periop ORACLE) randomized study. F1000Res. 2022 Sep 29;11:653. doi: 10.12688/f1000research.122286.2. eCollection 2022. |
| 32201572 | Derived | King CR, Abraham J, Kannampallil TG, Fritz BA, Ben Abdallah A, Chen Y, Henrichs B, Politi M, Torres BA, Mickle A, Budelier TP, McKinnon S, Gregory S, Kheterpal S, Wildes T, Avidan MS; TECTONICS Research Group. Protocol for the Effectiveness of an Anesthesiology Control Tower System in Improving Perioperative Quality Metrics and Clinical Outcomes: the TECTONICS randomized, pragmatic trial. F1000Res. 2019 Nov 29;8:2032. doi: 10.12688/f1000research.21016.1. eCollection 2019. |
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. Anesthesia Control Tower monitoring: Real time data will be monitored through the AlertWatch® system as well as the patient's EHR. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ASA Physical Status | Range, 1 to 6; 1 indicates healthy, 2 indicates mild systemic disease, 3 indicates severe systemic disease, 4 indicates severe systemic disease that is a constant threat to life, 5 indicates not expected to survive without surgery, 6 indicates neurologically deceased organ donor. In this study, only patients with an ASA 1 to 5 were collected. | Count of Participants | Participants |
|
|
|
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| Primary | Number of Participants With 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. | Patients that did not have a CAM-ICU performed, or CAM-ICU scores within 30 minutes of a documented deep level of sedation (Richmond Agitation Sedation Scale < -3) are excluded. All other delirium assessments within 7 days will be included, with any positive evaluations yielding a positive event. | Posted | Count of Participants | Participants | 7 days post-op |
|
|
|
|
| Primary | Number of Participants With 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. | Patients with tracheostomies and preoperative ventilation are excluded. Airway events within 24 hours after surgeries within 30 days of the index operation are excluded. That is, a 24 hour window of ventilation is allowed after all surgeries without triggering a positive event. | Posted | Count of Participants | Participants | 30 days post-op |
|
|
|
|
| Primary | Number of Participants With 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). | Patients with diagnosed renal failure, serum creatinine >4 mg/dl, and dialysis in the last week are excluded. | Posted | Count of Participants | Participants | 7 days post-op |
|
|
|
|
| Secondary | Temperature Management | Percentage of patients with Temperature ≥ 36°C at end of surgery. | Patients with missing secondary outcomes are not included in the analysis of those outcomes. | Posted | Count of Participants | Participants | 1 day |
|
|
|
|
| Secondary | Antibiotic Redosing | Percentage of patients with antibiotic redosing compliant with guidelines developed by the institutional pharmacy and therapeutics committee. | Patients without an indicated redosing event are excluded. | Posted | Count of Participants | Participants | 1 day |
|
|
|
|
| Secondary | Mean Arterial Pressure Management | Percentage time during surgery with mean arterial pressure ≥ 60 mmHg | Patients with missing secondary outcomes are not included in the analysis of those outcomes. | Posted | Mean | Standard Deviation | percentage of time | 1 day |
|
|
|
|
| Secondary | Mean Airway Pressure With Mechanical Ventilation | Percentage time during surgery with low PIP (peak inspiratory pressure) | Patients with missing secondary outcomes are not included in the analysis of those outcomes. | Posted | Mean | Standard Deviation | percentage of time | 1 day |
|
|
|
|
| Secondary | Blood Glucose Management | Percentage of patients with blood glucose ≥ 200 mg/dL at end of surgery. | Patients with missing secondary outcomes are not included in the analysis of those outcomes. | Posted | Count of Participants | Participants | 1 day |
|
|
|
|
| Secondary | Measured Anesthetic Concentration | Percentage of patients without ≥ 15 consecutive min of anesthetic concentration ≤ 0.3 MAC during anesthetic maintenance period. | Patients with doses of sedatives at greater than the following dose-rates are excluded: Propofol > 40 mcg/kg/min, Ketamine > 0.3 mg/kg/hr. Patients with missing secondary outcomes are not included in the analysis of those outcomes | Posted | Count of Participants | Participants | 1 day |
|
|
|
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| Secondary | Fresh Gas Flow Rates | Percentage of patients with efficient fresh gas flow for ≥90% of the anesthetic maintenance period. | Only times with > 0.3 age adjusted MAC are included. Patients with missing secondary outcomes are not included in the analysis of those outcomes | Posted | Count of Participants | Participants | 1 day |
|
|
|
|
| 899 |
| 39,750 |
| 0 |
| 39,750 |
| 0 |
| 39,750 |
| EG001 | 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. Anesthesia Control Tower monitoring: Real time data will be monitored through the AlertWatch® system as well as the patient's EHR. | 866 | 39,810 | 0 | 39,810 | 0 | 39,810 |
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