Multiple Organ FailureNCT03827369
The Blood Pressure Analysis on Critically Ill Patients
An observational study of Multiple Organ Failure and Intensive Care Unit Syndrome, run by Taoyuan General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Multiple Organ Failure, Intensive Care Unit Syndrome
- What is being tested?
- ICU patient
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Apr 2019to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients without severe arrhythmia admitted to the ICU of Taoyuan General Hospital.
Who may be able to join
- 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
Who cannot join
- Subject has severe arrhythmia
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan, 33004
About this study
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.
- Being tested
- ICU patient
- Keywords
- Blood pressure, Arterial pulse, Coefficient of variation of harmonic magnitude
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ICU patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start30 Apr 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taoyuan General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tzu-Yi Chuang, Principal investigator, Taoyuan General Hospital, Minstry of Healthy and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827369
- Sponsor's protocol ID
- TYGH107041
- Status last verified
- Mar 2020
- First submitted
- 30 Jan 2019
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Blood Pressure Analysis on Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03827369
- Acronym / sponsor ID
- TYGH107041
- Keywords
- Blood pressure, Arterial pulse, Coefficient of variation of harmonic magnitude
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taoyuan General HospitalOther government
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patient | – | Diagnostic Test: ICU patientPulse 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. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients without severe arrhythmia admitted to the ICU of Taoyuan General Hospital.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Subject has severe arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICU patientOur 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. | Diagnostic test | ICU patient |
Primary outcome
Coefficient of variation of harmonic magnitude
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzu-Yi Chuang principal investigator
Taoyuan General Hospital, Minstry of Healthy and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Organ Failure and Intensive Care Unit Syndrome, run by Taoyuan General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu-Yi Chuang (886-3-3699721 ext. 3787, revival_chuang@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficient of variation of harmonic magnitude (time frame: 15 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.