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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04020887
Other study ID # 201901180
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date December 6, 2021

Study information

Verified date December 2021
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

A proof-of-concept study in perioperative telemedicine that aims to demonstrate the (i) acceptability and (ii) utility of integrating telemedicine into the PACU environment. This proof-of-concept study will be conducted in the PACU.


Recruitment information / eligibility

Status Completed
Enrollment 560
Est. completion date December 6, 2021
Est. primary completion date December 6, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Adults (age = 18) undergoing elective surgery at Barnes Jewish Hospital in St. Louis, Missouri will be enrolled

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions. Percent of patients the telemedicine center participated in the hand-off process from OR to the PACU in both the observation and interaction phases. Participation by the telemedicine center was successful if the telemedicine center could both remotely join the hand-off process and collect relevant patient care information. up to 1 day
Secondary Detection of Physiological Derangements in PACU Patients The proportion of physiological derangements identified in the telemedicine center in both the observation and interaction phases approximately 1 day
Secondary Identification of Symptoms Requiring Treatment in PACU Patients Number of patients identified with symptoms requiring treatment in PACU such as pain or nausea in both the observation and interaction phases approximately 1 day
Secondary Recognition of Situations Requiring Emergency Medical Intervention The number of patients identified requiring emergency medical intervention in both the observation and interaction phases approximately 1 day
Secondary Determination of Patient Readiness for PACU Discharge Number of patients determined to be ready for PACU discharge prior to documentation by the PACU Team in both the observation and interaction phases approximately 1 day
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