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Telemedicine Control Tower for the Post-Anesthesia Care Unit (PACU Telemed)

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ClinicalTrials.gov Identifier: NCT04020887
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Avidan, Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
Elective Surgery Device: Alertwatch - Interaction Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The first phase is an observation phase and the next phase is an interaction phase.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Proof-of-concept Observational Study Evaluating the Acceptability and Utility of a Telemedicine Solution for the Post Anesthesia Care Unit
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
No Intervention: Observation Phase
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.
Experimental: Interaction Phase
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
Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU




Primary Outcome Measures :
  1. Difference in time to PACU discharge determination from observation to interaction phase [ Time Frame: 6 months ]
    The difference in discharge readiness time between the observation and interaction phases will be compared


Secondary Outcome Measures :
  1. Demonstrate the potential ability of a remote telemedicine center for the PACU to assist with PACU functions. [ Time Frame: 6 months ]
    Percent of patients in the interaction phase when the telemedicine center participates in the hand-off process from OR to the PACU

  2. Detection of physiological derangements in PACU patients [ Time Frame: approximately 1 day ]
    The proportion of physiological derangements identified in the telemedicine center in both the observation and interaction phases

  3. Identification of symptoms requiring treatment in PACU patients [ Time Frame: approximately 1 day ]
    Number of patients identified with symptoms requiring treatment in PACU such as pain or nausea in both the observation and interaction phases

  4. Recognition of situations requiring emergency medical intervention [ Time Frame: approximately 1 day ]
    The number of patients identified requiring emergency medical intervention in both the observation and interaction phases

  5. Determination of patient readiness for PACU discharge [ Time Frame: approximately 1 day ]
    Number of patients determined to be ready for PACU discharge prior to documentation by the PACU Team in both the observation and interaction phases



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Adults (age ≥ 18) undergoing elective surgery at Barnes Jewish Hospital in St. Louis, Missouri will be enrolled

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020887


Contacts
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Contact: Thaddeus Budelier, MD 314-747-0421 thaddeus.budelier@wustl.edu
Contact: Sherry McKinnon, BS 314-286-1768 smckinnon@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Michael S Avidan, MBBcH Washington University School of Medicine

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Responsible Party: Michael Avidan, Professor of Anesthesiology and Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04020887     History of Changes
Other Study ID Numbers: 201901180
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Michael Avidan, Washington University School of Medicine:
Telemedicine
Post Anesthesia Care Unit (PACU)

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs