SurgeryPhase 3TECTONICSNCT03923699

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

A Phase 3 study of Surgery and Surgery--Complications, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgery, Surgery--Complications, Perioperative/Postoperative Complications
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79,560 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2019to 31 Jan 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients 18 years or older undergoing surgery at Barnes Jewish Hospital in St. Louis, MO

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety - Randomized Pragmatic Trial

Read the 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.

Conditions: Surgery, Surgery--Complications, Perioperative/Postoperative Complications
Being tested: Anesthesia Control Tower monitoring
Keywords: Telemedicine, Anesthesia Control Tower, Machine Learning, Forecasting Algorithms, Decision Support, Randomized Controlled Trial
Medical subject headings: Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anesthesia Control Tower monitoringDevice
Real time data will be monitored through the AlertWatch® system as well as the patient's EHR.

Study groups in NCT03923699
Study group	Role	What they receive
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. Receives: Device: Anesthesia Control Tower monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 7 days post-op

Secondary outcomes (7)

Temperature Management
Percentage of patients with Temperature ≥ 36°C at end of surgery.
Measured: 1 day
Antibiotic Redosing
Percentage of patients with antibiotic redosing compliant with guidelines developed by the institutional pharmacy and therapeutics committee.
Measured: 1 day
Mean Arterial Pressure Management
Percentage time during surgery with mean arterial pressure ≥ 60 mmHg
Measured: 1 day
Mean Airway Pressure With Mechanical Ventilation
Percentage time during surgery with low PIP (peak inspiratory pressure)
Measured: 1 day
Blood Glucose Management
Percentage of patients with blood glucose ≥ 200 mg/dL at end of surgery.
Measured: 1 day
Measured Anesthetic Concentration
Percentage of patients without ≥ 15 consecutive min of anesthetic concentration ≤ 0.3 MAC during anesthetic maintenance period.
Measured: 1 day
Fresh Gas Flow Rates
Percentage of patients with efficient fresh gas flow for ≥90% of the anesthetic maintenance period.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201931 Jan 2023

First posted23 Apr 2019
Study start1 Jul 2019
Primary completion31 Jan 2023
Study completion31 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for SurgeryStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized Parallel assignment
Masking: Single blind
Who is masked: Participant
Enrolment: 79,560 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03923699
Sponsor's protocol ID: 201903026
Other IDs: R01NR017916
Acronym: TECTONICS
Status last verified: Jun 2024
First submitted: 6 Mar 2019
Last updated: 17 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: 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.

Publications

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.
PubMed 39753404
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.
PubMed 38826207
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.
PubMed 37547785
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.
PubMed 32201572

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telemedicine Control Tower for the Operating Room: Navigating Information, Care and Safety - Randomized Pragmatic Trial
ClinicalTrials.gov ID: NCT03923699
Acronym / sponsor ID: TECTONICS / 201903026
Conditions: Surgery, Surgery--Complications, Perioperative/Postoperative Complications
Keywords: Telemedicine, Anesthesia Control Tower, Machine Learning, Forecasting Algorithms, Decision Support, Randomized Controlled Trial
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 79,560 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 1 Jul 2019 (actual)
Primary completion: 31 Jan 2023 (actual)
Study completion: 31 Jan 2023 (actual)
First posted: 23 Apr 2019 (actual)
Results: Posted 17 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Randomized Parallel assignment

Arm	Type	Receives
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	Device: Anesthesia Control Tower monitoringClinicians 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All patients 18 years or older undergoing surgery at Barnes Jewish Hospital in St. Louis, MO

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anesthesia Control Tower monitoringReal time data will be monitored through the AlertWatch® system as well as the patient's EHR.	Device	Anesthesia Control Tower monitoring

Primary outcome

Thirty-day Postoperative Mortality
Time frame: 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
Time frame: 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
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.
Number of Participants With Postoperative Acute Kidney Injury
Time frame: 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).

7 secondary outcomes

Temperature Management
Time frame: 1 day
Antibiotic Redosing
Time frame: 1 day
Mean Arterial Pressure Management
Time frame: 1 day
Mean Airway Pressure With Mechanical Ventilation
Time frame: 1 day
Blood Glucose Management
Time frame: 1 day
Measured Anesthetic Concentration
Time frame: 1 day
Fresh Gas Flow Rates
Time frame: 1 day

Results and safety

Results posted to the registry on 17 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care Arm	39,750	39,750
Anesthesia Control Tower Monitoring	39,810	39,810

Primary outcome: Thirty-day Postoperative Mortality

Time frame: 30 days post-op. Count of participants. Unit: Participants

Measure	Standard of Care Arm n = 39750	Anesthesia Control Tower Monitoring n = 39810
Value	899	866

Standard of Care Arm vs Anesthesia Control Tower Monitoring: Risk Ratio (RR): 0.96 (95% CI 0.85 to 1.08), p = 0.41, Regression, Poisson

Primary outcome: Number of Participants With Postoperative Delirium

Time frame: 7 days post-op. Count of participants. Unit: Participants

Measure	Standard of Care Arm n = 4711	Anesthesia Control Tower Monitoring n = 4681
Value	1506	1502

Standard of Care Arm vs Anesthesia Control Tower Monitoring: Risk Ratio (RR): 1.00 (95% CI 0.92 to 1.10), p = 0.92, Regression, Poisson

Population analysed: 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.

Primary outcome: Number of Participants With Postoperative Respiratory Failure

Time frame: 30 days post-op. Count of participants. Unit: Participants

Measure	Standard of Care Arm n = 37600	Anesthesia Control Tower Monitoring n = 37652
Value	1301	1282

Standard of Care Arm vs Anesthesia Control Tower Monitoring: Risk Ratio (RR): 0.98 (95% CI 0.89 to 1.09), p = 0.68, Regression, Poisson

Population analysed: 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.

Primary outcome: Number of Participants With Postoperative Acute Kidney Injury

Time frame: 7 days post-op. Count of participants. Unit: Participants

Measure	Standard of Care Arm n = 37240	Anesthesia Control Tower Monitoring n = 37393
Value	2784	2736

Standard of Care Arm vs Anesthesia Control Tower Monitoring: Risk Ratio (RR): 0.98 (95% CI 0.92 to 1.05), p = 0.42, Regression, Poisson

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

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days post-op. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care Arm	0 of 39,750 (0%)	0 of 39,750 (0%)	899 of 39,750
Anesthesia Control Tower Monitoring	0 of 39,810 (0%)	0 of 39,810 (0%)	866 of 39,810

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39753404King 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.
Derived from this study: PubMed 38826207King 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.
Derived from this study: PubMed 37547785Fritz 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.
Derived from this study: PubMed 32201572King 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.
Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael S Avidan, MBBCh principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Surgery and Surgery--Complications, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thirty-day Postoperative Mortality (time frame: 30 days post-op). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03923699, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.