AnesthesiaNCT04520919
Feasibility Study of a Hemodynamic Parameter Algorithm
An observational study of Anesthesia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
An algorithm to calculate hemodynamic parameters based on blood pressure waveform was developed by collecting arterial blood pressure of patients during surgery Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- anesthesia;Radial artery puncture
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients who need surgery
Who may be able to join
- surgery patients
Who cannot join
- Weight ≤18kg arrhythmology cardiac disfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
Min Yan, Doctor, zryanmin@zju.edu.cn
About this study
An algorithm to calculate hemodynamic parameters based on blood pressure waveform was developed by collecting arterial blood pressure of patients during surgery
- Conditions
- Anesthesia
- Being tested
- anesthesia;Radial artery puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia;Radial artery punctureOther
we chose the patients who need to monitor invasive blood pressure to obtain high-fidelity arterial waveforms
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial blood pressure
a high-fidelity blood pressure waveforms
Measured: 30min~1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Mar 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 139 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
- NCT04520919
- Sponsor's protocol ID
- 2019-001
- Status last verified
- Jan 2020
- First submitted
- 18 Aug 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Hemodynamic Parameter Algorithm
- ClinicalTrials.gov ID
- NCT04520919
- Acronym / sponsor ID
- 2019-001
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 20 Aug 2020 (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.
An algorithm to calculate hemodynamic parameters based on blood pressure waveform was developed by collecting arterial blood pressure of patients during surgery
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who need surgery
Key inclusion criteria (1 listed)
- surgery patients
Key exclusion criteria (1 listed)
- Weight ≤18kg arrhythmology cardiac disfunction
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 |
|---|---|---|
| anesthesia;Radial artery puncturewe chose the patients who need to monitor invasive blood pressure to obtain high-fidelity arterial waveforms | Other | – |
Primary outcome
arterial blood pressure
Time frame: 30min~1 hour
a high-fidelity blood pressure waveforms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact QIWEN YU, undergraduate (+8618668022199, yuqw@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial blood pressure (time frame: 30min~1 hour). 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 20 Aug 2020.