Telemedicine Control Tower for the Post-Anesthesia Care Unit

NCT04020887 | Completed Results FDA Device

• 1 other identifier: 201901180
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

A single center prospective before-and-after proof-of-concept study to evaluate a telemedicine center for the PACU.

Conditions

Elective Surgery

Keywords

Telemedicine; Post Anesthesia Care Unit (PACU)

Outcome Measures

Primary Outcomes (1)

• Difference in Time to PACU Discharge Determination From Observation to Interaction Phase

  The difference in discharge readiness time between the observation and interaction phases will be compared

  up to 1 day

Secondary Outcomes (5)

• Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions.

  up to 1 day

• Detection of Physiological Derangements in PACU Patients

  approximately 1 day

• Identification of Symptoms Requiring Treatment in PACU Patients

  approximately 1 day

• Recognition of Situations Requiring Emergency Medical Intervention

  approximately 1 day

• Determination of Patient Readiness for PACU Discharge

  approximately 1 day

Study Arms (2)

Observation Phase

NO INTERVENTION

In the first three months of this proof-of-concept study, a telemedicine center for the PACU will monitor patients assigned to PACU bays. Both telemedicine center clinicians and nurses caring for patients in these PACU bays will independently record information on patient physiological derangements, treatable symptoms, situations requiring urgent medical intervention, and discharge readiness (based on the modified Aldrete scale). During this phase of the study, clinicians in the telemedicine center will not communicate with clinicians in the PACU (nurses or physicians), unless there was a patient safety event.

Interaction Phase

EXPERIMENTAL

In the three months following the observation phase, clinicians in the telemedicine center will interact with clinicians and patients in the two designated PACU bays using audio-visual technology. The clinicians in the telemedicine center will continue to document information on physiological derangements, treatable symptoms, situations requiring urgent medical intervention, and discharge readiness.

Device: Alertwatch - Interaction

Interventions

Alertwatch - Interaction DEVICE

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

Interaction Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Adults (age ≥ 18) 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

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Budelier TP, King CR, Goswami S, Bansal A, Gregory SH, Wildes TS, Abraham J, McKinnon SL, Cooper A, Kangrga I, Martin JL Jr, Milbrandt M, Evers AS, Avidan MS. Protocol for a proof-of-concept observational study evaluating the potential utility and acceptability of a telemedicine solution for the post-anesthesia care unit. F1000Res. 2020 Oct 20;9:1261. doi: 10.12688/f1000research.26794.1. eCollection 2020.

  PMID: 33214879 DERIVED

Results Point of Contact

• Title: Thaddeus Budelier
• Organization: Washington University School of Medicine

thaddeus.budelier@wustl.edu

314-273-8646

Study Officials

• Michael S Avidan, MBBcH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Surgery

Model Details: The first phase is an observation phase and the next phase is an interaction phase.

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: July 16, 2019
• Study Start: March 1, 2020
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: July 19, 2023
• Results First Posted: July 19, 2023

Record last verified: 2021-12

Locations

US (1)