NCT05961358

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

July 6, 2023

Last Update Submit

February 20, 2025

Conditions

Keywords

arterial blood pressurecardiac outputadvanced hemodynamicmobile Applications

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

General anesthesia Patients

Subjects experiencing general anesthesia

Procedure: snapshots or videos of monitorProcedure: Pressure transducer

Interventions

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.

General anesthesia Patients

Arterial catheter were connected to conventional pressure transducers and Flotrac-Vigileo transducers.

General anesthesia Patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Invasive blood pressure monitoring
  • Aged 18-65 years
  • ASA class I-III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Transducers, Pressure

Intervention Hierarchy (Ancestors)

TransducersElectrical Equipment and SuppliesEquipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 27, 2023

Study Start

August 1, 2023

Primary Completion

January 30, 2025

Study Completion

May 30, 2025

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations