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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05961358
Other study ID # 2023-0554
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date August 30, 2024

Study information

Verified date July 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 Android/iOS application for mobile devices and application in patient management.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date August 30, 2024
Est. primary completion date August 25, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Invasive blood pressure monitoring - Aged 18-65 years - ASA class I-III Exclusion Criteria: - Spontaneous breathing - Prone position - Non-radial artery cannulation - Aortic regurgitation - Heart arrhythmia - Heart rate > 100/min - Intra-aortic balloon pump - Peripheral vascular disease - Body weight < 40 kg

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
snapshots or videos of monitor
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 transducer
Arterial catheter were connected to conventional pressure transducers and Flotrac-Vigileo transducers.

Locations

Country Name City State
China The Second Affiliated Hospital of Zhejiang University anesthesiology department Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of mobile device analysis results with Vigileo analysis results Cardiac output and Stroke Volume Variation were acquired by mobile device and Vigileo 1 day
Primary 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 1 day
Primary 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 1 day
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