NCT03827369

Brief Summary

The study is to explore the relationship between coefficient of variation of harmonic magnitude (HCV) and different organ failures among those critically ill patients. In the future, we can act as a warning system on patients with multiple organ failures or terminal illness, also as an indicator of treatment effect.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

January 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

January 30, 2019

Last Update Submit

March 26, 2020

Conditions

Keywords

Blood pressureArterial pulseCoefficient of variation of harmonic magnitude

Outcome Measures

Primary Outcomes (1)

  • Coefficient of variation of harmonic magnitude

    We measure the blood pressure of participants with multiple organ failures (MOF) by pressure transducer during the 6 months study in the ICU of Taoyuan General Hospital. The radial artery pressure pulse of both hands are recorded with a pressure transducer fixed on the skin with tape and an adjustable belt with a small button to achieve suitable pressure.

    15 min

Study Arms (1)

ICU patient

Pulse pressure of the radical artery was obtained by arterial line. The output of the transducer was connected to an IBM PC for analysis via an A/D converter with sampling rate = 250 datapoints/sec. The pulse spectrum was analyzed with the Fourier transformation using T (period) = 1 pulse time.

Diagnostic Test: ICU patient

Interventions

ICU patientDIAGNOSTIC_TEST

Our study is to measure the coefficient of variation of the HCV of the radial arterial pulse among ICU patients with multiple organ failures (MOF). Patients admitted to Taoyuan General Hospital were recorded during the 6 months study.

ICU patient

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients without severe arrhythmia admitted to the ICU of Taoyuan General Hospital.

You may qualify if:

  • ICU patients in the 20-to-99 age range
  • Subjects agree to sign the Informed Consent Form and are willing to cooperate with Arterial pulse measurement

You may not qualify if:

  • Subject has severe arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyuan General Hospital, Ministry of Health and Welfare

Taoyuan District, 33004, Taiwan

RECRUITING

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tzu-Yi Chuang

    Taoyuan General Hospital, Minstry of Healthy and Welfare

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 1, 2019

Study Start

April 30, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 27, 2020

Record last verified: 2020-03

Locations