Elective SurgeryRCT PilotNCT06732921
Recovery Control Tower Feasibility Pilot
A study of Elective Surgery, run by Washington University School of Medicine at 1 site in United States.
Trial summary
A pilot study in perioperative telemedicine that aims to demonstrate the efficiency, and safety of integrating telemedicine into the PACU environment. This pilot study will expand on our previously conducted proof-of-concept study for a telemedicine solution in the PACU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,500 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 (18 years and older)
- 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: Protocol for a Pilot Interventional Study Evaluating the Efficiency and Safety of a Telemedicine Solution for the Post-Anesthesia Care Unit
A pilot study in perioperative telemedicine that aims to demonstrate the efficiency, and safety of integrating telemedicine into the PACU environment. This pilot study will expand on our previously conducted proof-of-concept study for a telemedicine solution in the PACU. If this pilot study proves to be successful, the study team intends subsequently to expand such a telemedicine solution to multiple clinical locations.
- Conditions
- Elective Surgery
- Being tested
- Alertwatch - Recovery Control Tower
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alertwatch - Recovery Control TowerDevice
Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU
| Study group | Role | What they receive |
|---|---|---|
| Recovery Control Tower (RCT) | Experimental | Clinicians in the RCT will remotely work with PACU clinicians to care for patients assigned to one of the two study bays. A version of AlertWatch® (AlertWatch, Ann Arbor, Michigan) decision-support software, customized for the PACU environment, will assist clinicians in the RCT to perform core PACU-related functions remotely. Caregility's iObserver, from the Caregility Cloud™ Virtual Care Platform, will be used for two-way video communication When feasible, RCT clinicians will join handoff activities from the OR to the PACU and discuss pertinent intraoperative events with clinical teams on the ground. RCT clinicians will document patient specific recovery tasks within AlertWatch to assist in tracking patient recovery progresses. RCT clinicians will be the initial point of contact for ongoing recovery care, such as order placements. The attending anesthesiologist in the RCT will assess patients' discharge readiness throughout their PACU stay. Receives: Device: Alertwatch - Recovery Control Tower |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in PACU
Time patient enters PACU to time patient leaves PACU
Measured: Day of surgery
Secondary outcomes (10)
Time to PACU sign-out by anesthesia clinician
Time patient enters PACU to time discharge note is signed in EHR by anesthesiologist
Measured: From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
Pain score in PACU
0 to 10 (numeric rating scale [NRS]) - 0 correspond to no pain, ≤ 3 to mild pain, 4-6 to moderate, and scores ≥7 to severe pain
Measured: From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
PONV status in PACU
None, resolved, resolved and tolerable, persists despite treatment, unable to evaluate
Measured: From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
Clinician interactions - Number of contacts RCT clinicians receive from PACU clinicians
Reason for contact will be logged (i.e. order placement requests, patient assessments)
Measured: From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
Clinician interactions - Number of contacts RCT clinicians make to PACU clinicians for on-the-ground intervention
Reason for contact will be logged
Measured: From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
Safety events - Return to hospital
New admission notes, and ED/urgent care notes
Measured: 24 hours
Safety events - Number of participants with elevation of care
Patients with floor to ICU transfer, and unplanned floor to OR (return to OR)
Measured: 24 Hours
Safety events - Number of participants with administration of rescue drugs
Events of Naloxone (opioid overdose) and Flumazenil (benzodiazepine overdose) administration
Measured: 24 Hours
Safety events - Significant event notes
To identify death events
Measured: 24 Hours
PACU clinician satisfaction
From monthly surveys
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start2 Oct 2023
- Primary completion31 Dec 2024
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8,500 participants (estimated)
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
- NCT06732921
- Sponsor's protocol ID
- 202305152
- Acronym
- RCT Pilot
- Status last verified
- Jul 2025
- First submitted
- 18 Sep 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Pilot Interventional Study Evaluating the Efficiency and Safety of a Telemedicine Solution for the Post-Anesthesia Care Unit
- ClinicalTrials.gov ID
- NCT06732921
- Acronym / sponsor ID
- RCT Pilot / 202305152
- Conditions
- Elective Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,500 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study in perioperative telemedicine that aims to demonstrate the efficiency, and safety of integrating telemedicine into the PACU environment. This pilot study will expand on our previously conducted proof-of-concept study for a telemedicine solution in the PACU. If this pilot study proves to be successful, the study team intends subsequently to expand such a telemedicine solution to multiple clinical locations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recovery Control Tower (RCT) | Experimental | Device: Alertwatch - Recovery Control TowerClinicians in the RCT will remotely work with PACU clinicians to care for patients assigned to one of the two study bays. A version of AlertWatch® (AlertWatch, Ann Arbor, Michigan) decision-support software, customized for the PACU environment, will assist clinicians in the RCT to perform core PACU-related functions remotely. Caregility's iObserver, from the Caregility Cloud™ Virtual Care Platform, will be used for two-way video communication When feasible, RCT clinicians will join handoff activities from the OR to the PACU and discuss pertinent intraoperative events with clinical teams on the ground. RCT clinicians will document patient specific recovery tasks within AlertWatch to assist in tracking patient recovery progresses. RCT clinicians will be the initial point of contact for ongoing recovery care, such as order placements. The attending anesthesiologist in the RCT will assess patients' discharge readiness throughout their PACU stay. |
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 - Recovery Control TowerDecision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU | Device | Recovery Control Tower (RCT) |
Primary outcome
Time spent in PACU
Time frame: Day of surgery
Time patient enters PACU to time patient leaves PACU
10 secondary outcomes
Time to PACU sign-out by anesthesia clinician
Time frame: From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
Pain score in PACU
Time frame: From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
PONV status in PACU
Time frame: From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
Clinician interactions - Number of contacts RCT clinicians receive from PACU clinicians
Time frame: From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
Clinician interactions - Number of contacts RCT clinicians make to PACU clinicians for on-the-ground intervention
Time frame: From the time the patient enters post-anesthesia care unit until time patient leaves post-anesthesia care unit, assessed up to 24 hours after surgery.
Safety events - Return to hospital
Time frame: 24 hours
Safety events - Number of participants with elevation of care
Time frame: 24 Hours
Safety events - Number of participants with administration of rescue drugs
Time frame: 24 Hours
Safety events - Significant event notes
Time frame: 24 Hours
PACU clinician satisfaction
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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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 of 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time spent in PACU (time frame: Day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2025.