Auxiliary Anesthesia Technique for Extracting Advanced Hemodynamic Parameters Based on Peripheral Arterial Waveform Photography

April 16, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University anesthesiology department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General anesthesia Patients
Subjects experiencing general anesthesia
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.
Procedure: Pressure transducer
Arterial catheter were connected to conventional pressure transducers and Flotrac-Vigileo transducers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day
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
1 day
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

August 25, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-0554

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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