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Completed

NCT Number: NCT02830126

Anesthesiology Control Tower

This study is a pragmatic, comparative effectiveness trial that will randomize approximately 12,000 adult surgical patients on an operating room (OR) level to a control or to an intervention group. All OR clinicians will have access to decision support software within the OR as a part of enhanced standard intraoperative care. The ACT will monitor patients in both groups and will provide additional support to the clinicians assigned to intervention ORs.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

The study will logically build on our previous work and utilize the already established infrastructure and resources of the intra-operative electronic medical record and the AlertWatch® alerting system. In conceptualizing this pilot study, as well as a larger follow-up trial focused on clinical outcomes, we have been mindful of challenges put forward to investigators by the National Institutes of Health, which seek to support low-cost, pragmatic, patient-centered randomized controlled trials. Specifically in relation to ACTFAST, (1) the highly developed, specialized IT infrastructure limits the investment required for embarking on this study; (2) the study will be conducted entirely within the context of routine clinical care, negating the need for dedicated trial-related visits; (3) access to registries with granular data on complications and patient-reported outcomes obviates the need for a new and costly infrastructure to track patient outcomes; (4) inclusion of large numbers of broadly representative patients in this study will be highly efficient with a waiver of informed consent. The design for this pilot proof-of-concept study will be a randomized clinical effectiveness trial. It will include a 6-month pre-intervention period during which time the ACT will be staffed but no alerts will be sent. This will allow for the training of controllers, refinement of alerts, and optimization of processes for obtaining and filtering information from diverse electronic sources. Following this period, the trial will begin and run for 12 months. On a daily basis during the study period (weekdays from 7am to 5pm), each operating room in Barnes-Jewish Hospital (BJH) will be eligible for randomization, which will occur using computer-generated assignment. Anesthesiology teams in ORs allocated to the experimental arm will receive the additional support of the ACT in the form of control-tower alerts that complement the AlertWatch® system. The outcomes of interest in this pilot study will be the usability and usefulness of the ACT, clinician adherence to recommendations for monitoring, documentation and therapeutic interventions, key physiologic variables such as temperature and blood pressure. We will also document patient outcomes including duration of postoperative hospital stay, incidence of postoperative morbidity (myocardial infarction, surgical site infection), functional recovery, and postoperative quality of life. Data on these endpoints will inform the design of a subsequent trial focused on clinically relevant outcomes, which will logically follow the current pilot randomized trial. All of the alerts included in this study will be chosen because they follow proven best intraoperative management practice and are in line with national metrics for quality and safety.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • On a daily basis during the study period (weekdays from 7am to 5pm), each operating room of Barnes-Jewish Hospital (BJH) will be eligible for randomization, which will occur at the level of the operating room using computer-generated assignment.

Exclusion criteria

-

Treatment and study plan

Anesthesiology Control Tower Feedback

Other

Clinicians in the Anesthesiology Control Tower will provide extra support for the anesthesiology team in the operating room.

Primary outcomes

  1. Compliance with recommendations for intraoperative temperature management

    Time frame: 1 day

    Proportion of patients with final recorded temperature in OR greater than 36 degrees Celsiustemperature, the target for this outcome was that the ACT intervention will increase the proportion of patients whose final recorded intraoperative temperature is above 36 degrees Celsius from 60% to 95%. For this calculation we assumed a standard deviation of core temperature of 0.9 degrees Celsius for both groups based on an unpublished EMR audit.

  2. Compliance with recommendations for intraoperative blood glucose management

    Time frame: 1 day

    Proportion of cases with blood glucose <=180 mg/dL upon arrival to the anesthesia recovery area

  3. Assess the usability of the Anesthesiology Control Tower (ACT) for an operating suite

    Time frame: 2 years

    Usability and usefulness are key features of successful implementation of new information technologies 24,99,100. The success of the proof-of-concept ACT implementation and its perceived usefulness and usability depend on participation and support of the entire anesthetic team. Our usability testing procedure will explore the 5Es (effectiveness, efficiency, engagement, error tolerance, ease of learning) needed to develop a useful and usable resource.

Secondary outcomes

  1. Intraoperative blood pressure management

    Time frame: 1 day

    Mean duration of time spent with Mean Arterial Pressure < 60 mmHg

  2. Temperature monitoring

    Time frame: 1 day

    Proportion of procedures lasting greater than 1 hour with documented temperature

  3. Antibiotic dosing

    Time frame: 1 day

    Proportion of procedures with appropriate administration of repeat doses of antibiotics

  4. Intraoperative blood glucose management

    Time frame: 1 day

    Proportion of cases with at least one dose of insulin administered for blood glucose greater than 180 mg/dL Intraoperative measurement of blood glucose in patients with type 1 diabetes undergoing cases >= 1 hour in length and patients with type 2 diabetes undergoing cases > 2 hours in length

  5. Train of four documentation

    Time frame: 1 day

    Proportion of cases with a train of four documented prior to extubation if a nondepolarizing neuromuscular blocking agent was administered

  6. Ventilator management

    Time frame: 1 day

    Proportion of cases with median tidal volume less than 10 mL/kg ideal body mass

  7. Volatile anesthetic utilization

    Time frame: 1 day

    Mean and standard deviation of fresh gas flow rates for cases with volatile anesthetic use > 80% of case duration

  8. Postoperative acute renal failure

    Time frame: 30 days

    Incidence of individual outcomes

  9. Postoperative atrial fibrillation

    Time frame: 30 days

    Incidence of individual outcomes

  10. Postoperative respiratory failure

    Time frame: 30 days

    Incidence of individual outcome

  11. Postoperative delirium

    Time frame: 30 days

    Incidence of individual outcome

  12. Intraoperative awareness

    Time frame: 30 days

    Incidence of individual outcomes

  13. Surgical site infection

    Time frame: 30 days

    Incidence of individual outcomes

  14. 30-day readmission

    Time frame: 30 days

    Incidence of individual outcomes

  15. 30-day mortality

    Time frame: 30 days

    Mortality will be assessed at 30 days

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Anesthesiology Control Tower: Feedback Alerts to Supplement Treatments (ACTFAST)

Acronym: ACTFAST

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2016
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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