Trial Outcomes & Findings for Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety (NCT NCT03923699)

NCT ID: NCT03923699

Last Updated: 2024-07-17

Results Overview

This will include death of any cause occurring in or out of the hospital, within 30 days of the index surgery.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 79560 participants
• Primary outcome timeframe: 30 days post-op
• Results posted on: 2024-07-17

Participant Flow

Unit of analysis: Operating Room Days

Participant milestones

Measure	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.	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.
Overall Study STARTED	39750 17907	39810 18091
Overall Study COMPLETED	39750 17907	39810 18091
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard of Care Arm n=39750 Participants 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 n=39810 Participants 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.	Total n=79560 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 17.0 • n=5 Participants	57.2 years STANDARD_DEVIATION 16.8 • n=7 Participants	57.2 years STANDARD_DEVIATION 16.9 • n=5 Participants
Sex/Gender, Customized Female	19752 Participants n=5 Participants	19813 Participants n=7 Participants	39565 Participants n=5 Participants
Sex/Gender, Customized Male	19994 Participants n=5 Participants	19992 Participants n=7 Participants	39986 Participants n=5 Participants
Sex/Gender, Customized Unknown or Other	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	112 Participants n=5 Participants	111 Participants n=7 Participants	223 Participants n=5 Participants
Race (NIH/OMB) Asian	417 Participants n=5 Participants	453 Participants n=7 Participants	870 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	58 Participants n=5 Participants	63 Participants n=7 Participants	121 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7776 Participants n=5 Participants	7875 Participants n=7 Participants	15651 Participants n=5 Participants
Race (NIH/OMB) White	27595 Participants n=5 Participants	27628 Participants n=7 Participants	55223 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3792 Participants n=5 Participants	3680 Participants n=7 Participants	7472 Participants n=5 Participants
Region of Enrollment United States	39750 participants n=5 Participants	39810 participants n=7 Participants	79560 participants n=5 Participants
ASA Physical Status ASA 1	1406 Participants n=5 Participants	1413 Participants n=7 Participants	2819 Participants n=5 Participants
ASA Physical Status ASA 2	12071 Participants n=5 Participants	12117 Participants n=7 Participants	24188 Participants n=5 Participants
ASA Physical Status ASA 3	17295 Participants n=5 Participants	17282 Participants n=7 Participants	34577 Participants n=5 Participants
ASA Physical Status ASA 4	4009 Participants n=5 Participants	4034 Participants n=7 Participants	8043 Participants n=5 Participants
ASA Physical Status ASA 5	132 Participants n=5 Participants	120 Participants n=7 Participants	252 Participants n=5 Participants
ASA Physical Status Unknown or Other	4837 Participants n=5 Participants	4844 Participants n=7 Participants	9681 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post-op

This will include death of any cause occurring in or out of the hospital, within 30 days of the index surgery.

Outcome measures

Measure	Standard of Care Arm n=39750 Participants 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 n=39810 Participants 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.
Thirty-day Postoperative Mortality	899 Participants	866 Participants

PRIMARY outcome

Timeframe: 7 days post-op

Population: 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.

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.

Outcome measures

Measure	Standard of Care Arm n=4711 Participants 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 n=4681 Participants 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.
Number of Participants With Postoperative Delirium	1506 Participants	1502 Participants

PRIMARY outcome

Timeframe: 30 days post-op

Population: 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.

Defined as mechanical ventilation for greater than 24 hours after surgery, or unplanned postoperative re-intubation and mechanical ventilation within 30 days of surgery.

Outcome measures

Measure	Standard of Care Arm n=37600 Participants 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 n=37652 Participants 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.
Number of Participants With Postoperative Respiratory Failure	1301 Participants	1282 Participants

PRIMARY outcome

Timeframe: 7 days post-op

Population: Patients with diagnosed renal failure, serum creatinine \>4 mg/dl, and dialysis in the last week are excluded.

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).

Outcome measures

Measure	Standard of Care Arm n=37240 Participants 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 n=37393 Participants 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.
Number of Participants With Postoperative Acute Kidney Injury	2784 Participants	2736 Participants

SECONDARY outcome

Timeframe: 1 day

Population: Patients with missing secondary outcomes are not included in the analysis of those outcomes.

Percentage of patients with Temperature ≥ 36°C at end of surgery.

Outcome measures

Measure	Standard of Care Arm n=34340 Participants 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 n=34711 Participants 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.
Temperature Management	27101 Participants	27398 Participants

SECONDARY outcome

Timeframe: 1 day

Population: Patients without an indicated redosing event are excluded.

Percentage of patients with antibiotic redosing compliant with guidelines developed by the institutional pharmacy and therapeutics committee.

Outcome measures

Measure	Standard of Care Arm n=5811 Participants 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 n=5919 Participants 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.
Antibiotic Redosing	5520 Participants	5629 Participants

SECONDARY outcome

Timeframe: 1 day

Population: Patients with missing secondary outcomes are not included in the analysis of those outcomes.

Percentage time during surgery with mean arterial pressure ≥ 60 mmHg

Outcome measures

Measure	Standard of Care Arm n=39032 Participants 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 n=39127 Participants 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.
Mean Arterial Pressure Management	0.96 percentage of time Standard Deviation 0.08	0.96 percentage of time Standard Deviation 0.08

SECONDARY outcome

Timeframe: 1 day

Population: Patients with missing secondary outcomes are not included in the analysis of those outcomes.

Percentage time during surgery with low PIP (peak inspiratory pressure)

Outcome measures

Measure	Standard of Care Arm n=30306 Participants 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 n=30573 Participants 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.
Mean Airway Pressure With Mechanical Ventilation	0.92 percentage of time Standard Deviation 0.21	0.92 percentage of time Standard Deviation 0.22

SECONDARY outcome

Timeframe: 1 day

Population: Patients with missing secondary outcomes are not included in the analysis of those outcomes.

Percentage of patients with blood glucose ≥ 200 mg/dL at end of surgery.

Outcome measures

Measure	Standard of Care Arm n=32435 Participants 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 n=32437 Participants 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.
Blood Glucose Management	1786 Participants	1848 Participants

SECONDARY outcome

Timeframe: 1 day

Population: 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

Percentage of patients without ≥ 15 consecutive min of anesthetic concentration ≤ 0.3 MAC during anesthetic maintenance period.

Outcome measures

Measure	Standard of Care Arm n=30175 Participants 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 n=30460 Participants 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.
Measured Anesthetic Concentration	29851 Participants	30087 Participants

SECONDARY outcome

Timeframe: 1 day

Population: Only times with \> 0.3 age adjusted MAC are included. Patients with missing secondary outcomes are not included in the analysis of those outcomes

Percentage of patients with efficient fresh gas flow for ≥90% of the anesthetic maintenance period.

Outcome measures

Measure	Standard of Care Arm n=26739 Participants 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 n=26837 Participants 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.
Fresh Gas Flow Rates	19899 Participants	19839 Participants

Adverse Events

Standard of Care Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 899 deaths

Anesthesia Control Tower Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 866 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Kannampallil

Washington University School of Medicine

Phone: (314) 273-7801

Email: thomas.k@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place