Elective SurgeryPACU TelemedNCT04020887
Telemedicine Control Tower for the Post-Anesthesia Care Unit
A study testing Alertwatch - Interaction in people with Elective Surgery, run by Washington University School of Medicine at 1 site in United States.
Trial summary
A single center prospective before-and-after proof-of-concept study to evaluate a telemedicine center for the PACU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Surgery
- What is being tested?
- Alertwatch - Interaction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 6 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Adults (age ≥ 18) undergoing elective surgery at Barnes Jewish Hospital in St. Louis, Missouri will be enrolled
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Proof-of-concept Observational Study Evaluating the Acceptability and Utility of a Telemedicine Solution for the Post Anesthesia Care Unit
A single center prospective before-and-after proof-of-concept study to evaluate a telemedicine center for the PACU.
Read the 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.
- Conditions
- Elective Surgery
- Being tested
- Alertwatch - Interaction
- Keywords
- Telemedicine, Post Anesthesia Care Unit (PACU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alertwatch - InteractionDevice
Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Alertwatch - Interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 day
Secondary outcomes (5)
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.
Measured: up to 1 day
Detection of Physiological Derangements in PACU Patients
The proportion of physiological derangements identified in the telemedicine center in both the observation and interaction phases
Measured: approximately 1 day
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
Measured: approximately 1 day
Recognition of Situations Requiring Emergency Medical Intervention
The number of patients identified requiring emergency medical intervention in both the observation and interaction phases
Measured: approximately 1 day
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
Measured: approximately 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Mar 2020
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective SurgeryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The first phase is an observation phase and the next phase is an interaction phase.
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Avidan, Washington University School of Medicine
- Investigators
- Michael S Avidan, MBBcH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020887
- Sponsor's protocol ID
- 201901180
- Acronym
- PACU Telemed
- Status last verified
- Dec 2021
- First submitted
- 6 Mar 2019
- Last updated
- 19 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 33214879
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept Observational Study Evaluating the Acceptability and Utility of a Telemedicine Solution for the Post Anesthesia Care Unit
- ClinicalTrials.gov ID
- NCT04020887
- Acronym / sponsor ID
- PACU Telemed / 201901180
- Conditions
- Elective Surgery
- Keywords
- Telemedicine, Post Anesthesia Care Unit (PACU)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Posted 19 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single center prospective before-and-after proof-of-concept study to evaluate a telemedicine center for the PACU.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first phase is an observation phase and the next phase is an interaction phase.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Alertwatch - InteractionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alertwatch - InteractionDecision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU | Device | Interaction Phase |
Primary outcome
Difference in Time to PACU Discharge Determination From Observation to Interaction Phase
Time frame: up to 1 day
The difference in discharge readiness time between the observation and interaction phases will be compared
5 secondary outcomes
Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions.
Time frame: up to 1 day
Detection of Physiological Derangements in PACU Patients
Time frame: approximately 1 day
Identification of Symptoms Requiring Treatment in PACU Patients
Time frame: approximately 1 day
Recognition of Situations Requiring Emergency Medical Intervention
Time frame: approximately 1 day
Determination of Patient Readiness for PACU Discharge
Time frame: approximately 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33214879Budelier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Avidan, MBBcH principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alertwatch - Interaction in people with Elective Surgery, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Time to PACU Discharge Determination From Observation to Interaction Phase (time frame: up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04020887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.