AnesthesiaNCT05961358
Auxiliary Anesthesia Technique for Extracting Advanced Hemodynamic Parameters Based on Peripheral Arterial Waveform Photography
An observational study of Anesthesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In this study, the arterial blood pressure waveform was digitized by snapshots or videos of the patient monitor to further estimate advanced hemodynamic parameters, so as to realize continuous and automatic monitoring of advanced hemodynamics on mobile devices to assist anesthesia, with a view to developing an… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- snapshots or videos of monitor and Pressure transducer
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 30 May 2025
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants for this study will be recruited at the Second Affiliated Hospital Zhejiang University School of Medicine. The study participants will be adult general anesthesia patients.
Who may be able to join
- Invasive blood pressure monitoring
- Aged 18-65 years
- ASA class I-III
Who cannot join
- Spontaneous breathing
- Prone position
- Non-radial artery cannulation
- Aortic regurgitation
- Heart arrhythmia
- Heart rate > 100/min
Show all 9Show fewer
- Intra-aortic balloon pump
- Peripheral vascular disease
- Body weight < 40 kg
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
About this study
In this study, the arterial blood pressure waveform was digitized by snapshots or videos of the patient monitor to further estimate advanced hemodynamic parameters, so as to realize continuous and automatic monitoring of advanced hemodynamics on mobile devices to assist anesthesia, with a view to developing an Android/iOS application for mobile devices and application in patient management.
- Conditions
- Anesthesia
- Being tested
- snapshots or videos of monitor, Pressure transducer
- Keywords
- arterial blood pressure, cardiac output, advanced hemodynamic, mobile Applications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
snapshots or videos of monitorProcedure or surgery
The mobile device（a phone）was used to obtain the screen image of the monitor, and the arterial blood pressure waveform is extracted by image processing technology.
Pressure transducerProcedure or surgery
Arterial catheter were connected to conventional pressure transducers and Flotrac-Vigileo transducers.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia Patients | Subjects experiencing general anesthesia Receives: Procedure: snapshots or videos of monitor; Procedure: Pressure transducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mobile device analysis results with Vigileo analysis results
Cardiac output and Stroke Volume Variation were acquired by mobile device and Vigileo
Measured: 1 day
Comparison of arterial waveform collected directly analysis results and Vigileo analysis results
Cardiac output and Stroke Volume Variation were acquired by Vigileo and arterial waveform collected directly analysis
Measured: 1 day
Comparison of arterial waveform collected directly analysis results and mobile device analysis results
Cardiac output and Stroke Volume Variation were acquired by mobile device and arterial waveform collected directly analysis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2023
- Primary completion30 Jan 2025
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961358
- Sponsor's protocol ID
- 2023-0554
- Status last verified
- Feb 2025
- First submitted
- 6 Jul 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auxiliary Anesthesia Technique for Extracting Advanced Hemodynamic Parameters Based on Peripheral Arterial Waveform Photography
- ClinicalTrials.gov ID
- NCT05961358
- Acronym / sponsor ID
- 2023-0554
- Conditions
- Anesthesia
- Keywords
- arterial blood pressure, cardiac output, advanced hemodynamic, mobile Applications
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 27 Jul 2023 (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.
In this study, the arterial blood pressure waveform was digitized by snapshots or videos of the patient monitor to further estimate advanced hemodynamic parameters, so as to realize continuous and automatic monitoring of advanced hemodynamics on mobile devices to assist anesthesia, with a view to developing an Android/iOS application for mobile devices and application in patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General anesthesia Patients | – | Procedure: snapshots or videos of monitor, Procedure: Pressure transducerSubjects experiencing general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants for this study will be recruited at the Second Affiliated Hospital Zhejiang University School of Medicine. The study participants will be adult general anesthesia patients.
Key inclusion criteria (3 listed)
- Invasive blood pressure monitoring
- Aged 18-65 years
- ASA class I-III
Key exclusion criteria (9 listed)
- Spontaneous breathing
- Prone position
- Non-radial artery cannulation
- Aortic regurgitation
- Heart arrhythmia
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 |
|---|---|---|
| snapshots or videos of monitorThe mobile device（a phone）was used to obtain the screen image of the monitor, and the arterial blood pressure waveform is extracted by image processing technology. | Procedure or surgery | General anesthesia Patients |
| Pressure transducerArterial catheter were connected to conventional pressure transducers and Flotrac-Vigileo transducers. | Procedure or surgery | General anesthesia Patients |
Primary outcome
Comparison of mobile device analysis results with Vigileo analysis results
Time frame: 1 day
Cardiac output and Stroke Volume Variation were acquired by mobile device and Vigileo
Comparison of arterial waveform collected directly analysis results and Vigileo analysis results
Time frame: 1 day
Cardiac output and Stroke Volume Variation were acquired by Vigileo and arterial waveform collected directly analysis
Comparison of arterial waveform collected directly analysis results and mobile device analysis results
Time frame: 1 day
Cardiac output and Stroke Volume Variation were acquired by mobile device and arterial waveform collected directly analysis
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 24 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. 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 24 Feb 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 China. 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?
Comparison of mobile device analysis results with Vigileo analysis results (time frame: 1 day). The study lists 3 primary outcomes in all. 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 24 Feb 2025.