Telemedicine Control Tower for the Post-Anesthesia Care Unit

NCT ID: NCT04020887

Last Updated: 2023-07-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-12-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Elective Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

The first phase is an observation phase and the next phase is an interaction phase.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Alertwatch - Interaction

Intervention Type DEVICE

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

Interventions

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Alertwatch - Interaction

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Adults (age ≄ 18) undergoing elective surgery at Barnes Jewish Hospital in St. Louis, Missouri will be enrolled
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Michael Avidan

Professor of Anesthesiology and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael S Avidan, MBBcH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33214879 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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201901180

Identifier Type: -

Identifier Source: org_study_id

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