Perioperative/Postoperative Complications, Surgery, Surgery--Complications
Conditions
Keywords
Telemedicine, Anesthesia Control Tower, Machine Learning, Forecasting Algorithms, Decision Support, Randomized Controlled Trial
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.
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.
Interventions
DEVICEAnesthesia Control Tower monitoring
Real time data will be monitored through the AlertWatch® system as well as the patient's EHR.
Sponsors
National Institute of Nursing Research (NINR)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Anesthesia practitioner un-blinded to intervention, subject blinded to intervention, data analyst blinded to intervention, ACT Clinicians un-blinded to intervention
Intervention model description
Randomized Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients 18 years or older undergoing surgery at Barnes Jewish Hospital in St. Louis, MO
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thirty-day Postoperative Mortality | 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. |
| Number of Participants With Postoperative Delirium | 7 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. |
| Number of Participants With Postoperative Respiratory Failure | 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. |
| Number of Participants With Postoperative Acute Kidney Injury | 7 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose Management | 1 day | Percentage of patients with blood glucose ≥ 200 mg/dL at end of surgery. |
| Temperature Management | 1 day | Percentage of patients with Temperature ≥ 36°C at end of surgery. |
| Fresh Gas Flow Rates | 1 day | Percentage of patients with efficient fresh gas flow for ≥90% of the anesthetic maintenance period. |
| Measured Anesthetic Concentration | 1 day | Percentage of patients without ≥ 15 consecutive min of anesthetic concentration ≤ 0.3 MAC during anesthetic maintenance period. |
| Antibiotic Redosing | 1 day | Percentage of patients with antibiotic redosing compliant with guidelines developed by the institutional pharmacy and therapeutics committee. |
| Mean Arterial Pressure Management | 1 day | Percentage time during surgery with mean arterial pressure ≥ 60 mmHg |
| Mean Airway Pressure With Mechanical Ventilation | 1 day | Percentage time during surgery with low PIP (peak inspiratory pressure) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39,750 |
| 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. | 39,810 |
| Total | 79,560 |
Baseline characteristics
| Characteristic | Standard of Care Arm | Total | Anesthesia Control Tower Monitoring |
|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 17 | 57.2 years STANDARD_DEVIATION 16.9 | 57.2 years STANDARD_DEVIATION 16.8 |
| ASA Physical Status ASA 1 | 1406 Participants | 2819 Participants | 1413 Participants |
| ASA Physical Status ASA 2 | 12071 Participants | 24188 Participants | 12117 Participants |
| ASA Physical Status ASA 3 | 17295 Participants | 34577 Participants | 17282 Participants |
| ASA Physical Status ASA 4 | 4009 Participants | 8043 Participants | 4034 Participants |
| ASA Physical Status ASA 5 | 132 Participants | 252 Participants | 120 Participants |
| ASA Physical Status Unknown or Other | 4837 Participants | 9681 Participants | 4844 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 112 Participants | 223 Participants | 111 Participants |
| Race (NIH/OMB) Asian | 417 Participants | 870 Participants | 453 Participants |
| Race (NIH/OMB) Black or African American | 7776 Participants | 15651 Participants | 7875 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 58 Participants | 121 Participants | 63 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3792 Participants | 7472 Participants | 3680 Participants |
| Race (NIH/OMB) White | 27595 Participants | 55223 Participants | 27628 Participants |
| Region of Enrollment United States | 39750 participants | 79560 participants | 39810 participants |
| Sex/Gender, Customized Female | 19752 Participants | 39565 Participants | 19813 Participants |
| Sex/Gender, Customized Male | 19994 Participants | 39986 Participants | 19992 Participants |
| Sex/Gender, Customized Unknown or Other | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 899 / 39,750 | 866 / 39,810 |
| other Total, other adverse events | 0 / 39,750 | 0 / 39,810 |
| serious Total, serious adverse events | 0 / 39,750 | 0 / 39,810 |
Outcome results
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).
Time frame: 7 days post-op
Population: Patients with diagnosed renal failure, serum creatinine \>4 mg/dl, and dialysis in the last week are excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Number of Participants With Postoperative Acute Kidney Injury | 2784 Participants |
| Anesthesia Control Tower Monitoring | Number of Participants With Postoperative Acute Kidney Injury | 2736 Participants |
p-value: 0.4295% CI: [0.92, 1.05]Regression, Poisson
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Number of Participants With Postoperative Delirium | 1506 Participants |
| Anesthesia Control Tower Monitoring | Number of Participants With Postoperative Delirium | 1502 Participants |
p-value: 0.9295% CI: [0.92, 1.1]Regression, Poisson
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Number of Participants With Postoperative Respiratory Failure | 1301 Participants |
| Anesthesia Control Tower Monitoring | Number of Participants With Postoperative Respiratory Failure | 1282 Participants |
p-value: 0.6895% CI: [0.89, 1.09]Regression, Poisson
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.
Time frame: 30 days post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Thirty-day Postoperative Mortality | 899 Participants |
| Anesthesia Control Tower Monitoring | Thirty-day Postoperative Mortality | 866 Participants |
p-value: 0.4195% CI: [0.85, 1.08]Regression, Poisson
Secondary
Antibiotic Redosing
Percentage of patients with antibiotic redosing compliant with guidelines developed by the institutional pharmacy and therapeutics committee.
Time frame: 1 day
Population: Patients without an indicated redosing event are excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Antibiotic Redosing | 5520 Participants |
| Anesthesia Control Tower Monitoring | Antibiotic Redosing | 5629 Participants |
p-value: 0.9595% CI: [0.95, 1.05]Regression, Poisson
Secondary
Blood Glucose Management
Percentage of patients with blood glucose ≥ 200 mg/dL at end of surgery.
Time frame: 1 day
Population: Patients with missing secondary outcomes are not included in the analysis of those outcomes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Blood Glucose Management | 1786 Participants |
| Anesthesia Control Tower Monitoring | Blood Glucose Management | 1848 Participants |
p-value: 0.395% CI: [0.95, 1.13]Regression, Poisson
Secondary
Fresh Gas Flow Rates
Percentage of patients with efficient fresh gas flow for ≥90% of the anesthetic maintenance period.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Fresh Gas Flow Rates | 19899 Participants |
| Anesthesia Control Tower Monitoring | Fresh Gas Flow Rates | 19839 Participants |
p-value: 0.5195% CI: [0.97, 1.02]Regression, poisson
Secondary
Mean Airway Pressure With Mechanical Ventilation
Percentage time during surgery with low PIP (peak inspiratory pressure)
Time frame: 1 day
Population: Patients with missing secondary outcomes are not included in the analysis of those outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Arm | Mean Airway Pressure With Mechanical Ventilation | 0.92 percentage of time | Standard Deviation 0.21 |
| Anesthesia Control Tower Monitoring | Mean Airway Pressure With Mechanical Ventilation | 0.92 percentage of time | Standard Deviation 0.22 |
p-value: 0.3795% CI: [-0.01, 0]Regression, Linear
Secondary
Mean Arterial Pressure Management
Percentage time during surgery with mean arterial pressure ≥ 60 mmHg
Time frame: 1 day
Population: Patients with missing secondary outcomes are not included in the analysis of those outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Arm | Mean Arterial Pressure Management | 0.96 percentage of time | Standard Deviation 0.08 |
| Anesthesia Control Tower Monitoring | Mean Arterial Pressure Management | 0.96 percentage of time | Standard Deviation 0.08 |
p-value: 0.2995% CI: [0, 0]Regression, Linear
Secondary
Measured Anesthetic Concentration
Percentage of patients without ≥ 15 consecutive min of anesthetic concentration ≤ 0.3 MAC during anesthetic maintenance period.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Measured Anesthetic Concentration | 29851 Participants |
| Anesthesia Control Tower Monitoring | Measured Anesthetic Concentration | 30087 Participants |
p-value: 0.8595% CI: [0.98, 1.02]Regression, Poisson
Secondary
Temperature Management
Percentage of patients with Temperature ≥ 36°C at end of surgery.
Time frame: 1 day
Population: Patients with missing secondary outcomes are not included in the analysis of those outcomes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Arm | Temperature Management | 27101 Participants |
| Anesthesia Control Tower Monitoring | Temperature Management | 27398 Participants |
p-value: 0.9995% CI: [0.98, 1.02]Regression, Poisson