The Blood Pressure Analysis on Critically Ill Patients

• Sponsor: Taoyuan General Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03827369
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 19.1
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Organ Failure; Intensive Care Unit Syndrome	Diagnostic Test: ICU patient

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The Blood Pressure Analysis on Critically Ill Patients
• Actual Study Start Date: Apr 30, 2019
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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; 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.

Outcome Measures

Primary Outcome Measures

1. Coefficient of variation of harmonic magnitude [15 min]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subject has severe arrhythmia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taoyuan General Hospital, Ministry of Health and Welfare	Taoyuan		Taiwan	33004

Sponsors and Collaborators

• Taoyuan General Hospital

Investigators

• Principal Investigator: Tzu-Yi Chuang, Taoyuan General Hospital, Minstry of Healthy and Welfare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taoyuan General Hospital
• ClinicalTrials.gov Identifier: NCT03827369
• Other Study ID Numbers: TYGH107041
• First Posted: Feb 1, 2019
• Last Update Posted: Mar 27, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Taoyuan General Hospital: Blood pressure; Arterial pulse; Coefficient of variation of harmonic magnitude
• Additional relevant MeSH terms: Multiple Organ Failure

Study Results

No Results Posted as of Mar 27, 2020