NCT06732921

Brief Summary

A pilot study in perioperative telemedicine that aims to demonstrate the efficiency, and safety of integrating telemedicine into the PACU environment. This pilot study will expand on our previously conducted proof-of-concept study for a telemedicine solution in the PACU. If this pilot study proves to be successful, the study team intends subsequently to expand such a telemedicine solution to multiple clinical locations.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

September 18, 2023

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time spent in PACU

    Time patient enters PACU to time patient leaves PACU

    Day of surgery

Secondary Outcomes (10)

  • Time to PACU sign-out by anesthesia clinician

    From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.

  • Pain score in PACU

    From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.

  • PONV status in PACU

    From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.

  • Clinician interactions - Number of contacts RCT clinicians receive from PACU clinicians

    From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.

  • Clinician interactions - Number of contacts RCT clinicians make to PACU clinicians for on-the-ground intervention

    From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.

  • +5 more secondary outcomes

Study Arms (1)

Recovery Control Tower (RCT)

EXPERIMENTAL

Clinicians in the RCT will remotely work with PACU clinicians to care for patients assigned to one of the two study bays. A version of AlertWatch® (AlertWatch, Ann Arbor, Michigan) decision-support software, customized for the PACU environment, will assist clinicians in the RCT to perform core PACU-related functions remotely. Caregility's iObserver, from the Caregility Cloud™ Virtual Care Platform, will be used for two-way video communication When feasible, RCT clinicians will join handoff activities from the OR to the PACU and discuss pertinent intraoperative events with clinical teams on the ground. RCT clinicians will document patient specific recovery tasks within AlertWatch to assist in tracking patient recovery progresses. RCT clinicians will be the initial point of contact for ongoing recovery care, such as order placements. The attending anesthesiologist in the RCT will assess patients' discharge readiness throughout their PACU stay.

Device: Alertwatch - Recovery Control Tower

Interventions

Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU

Recovery Control Tower (RCT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Adults (18 years and older) * Undergoing elective surgery at Barnes Jewish Hospital in St. Louis, Missouri will be enrolled.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Study Officials

  • Michael S Avidan, MBBcH

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Anesthesiology

Study Record Dates

First Submitted

September 18, 2023

First Posted

December 13, 2024

Study Start

October 2, 2023

Primary Completion

December 31, 2024

Study Completion

September 30, 2025

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations