Heart Rate VariabilityNCT01247727
Heart Rate Variability in Extracorporeal Membrane Oxygenation (ECMO) Patients
An observational study of Heart Rate Variability, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
National Taiwan University Hospital is the leading center for care of patients with extracorporeal membrane oxygenation (ECMO). The predictable factors associated with outcomes are still lacking in patients with the ECMO support. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2011to Dec 2012
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with the support of extracorporeal membrane oxygenation
Who may be able to join
- Adults patients (aged > 18 years; less than 90 years old) used ECMO for cardiopulmonary support
Who cannot join
- Patients used illicit drugs
- Patients received heart transplantation
- Patients have the history of arrhythmia
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Jin-Ming Wu, M.D., 886-0972653213, kptkptkpt@yahoo.com.tw
About this study
Official title: Clinical Application of Multimodal Physiological Signal Analysis in Critical Ill Patients Depending on Extracorporeal Membrane Oxygenation
National Taiwan University Hospital is the leading center for care of patients with extracorporeal membrane oxygenation (ECMO). The predictable factors associated with outcomes are still lacking in patients with the ECMO support. The aim of this study is to collect the electrical signals stored in the monitor of intensive care units (ICUs), which are analyzed by the bio-informatics software. The pre-, peri-, and post-ECMO heart rate variability, including linear and non-linear analysis is calculated to address the association with outcomes of patients with ECMO. In addition, we collected the demographics, body temperature, respiratory rate, and blood pressure to investigate the causes of heart rate variability.
Read the detailed description
Inclusion criteria:Adults patients (aged older than 18 years; less than 90 years old) used ECMO for cardiopulmonary support
Exclusion criteria:
- Patients used illicit drugs
- Patients received heart transplantation
- Patients have the history of arrhythmia
- Conditions
- Heart Rate Variability
- Keywords
- Heart rate variability, extracorporeal membrane oxygenation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startJul 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wen-Je Ko, M.D., Ph.D., Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247727
- Sponsor's protocol ID
- 201010075R
- Status last verified
- Mar 2011
- First submitted
- 22 Nov 2010
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Multimodal Physiological Signal Analysis in Critical Ill Patients Depending on Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT01247727
- Acronym / sponsor ID
- 201010075R
- Conditions
- Heart Rate Variability
- Keywords
- Heart rate variability, extracorporeal membrane oxygenation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 24 Nov 2010 (estimated)
- 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.
National Taiwan University Hospital is the leading center for care of patients with extracorporeal membrane oxygenation (ECMO). The predictable factors associated with outcomes are still lacking in patients with the ECMO support. The aim of this study is to collect the electrical signals stored in the monitor of intensive care units (ICUs), which are analyzed by the bio-informatics software. The pre-, peri-, and post-ECMO heart rate variability, including linear and non-linear analysis is calculated to address the association with outcomes of patients with ECMO. In addition, we collected the demographics, body temperature, respiratory rate, and blood pressure to investigate the causes of heart rate variability.
Detailed description
Inclusion criteria:Adults patients (aged older than 18 years; less than 90 years old) used ECMO for cardiopulmonary support
Exclusion criteria:
- Patients used illicit drugs
- Patients received heart transplantation
- Patients have the history of arrhythmia
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the support of extracorporeal membrane oxygenation
Key inclusion criteria (1 listed)
- Adults patients (aged > 18 years; less than 90 years old) used ECMO for cardiopulmonary support
Key exclusion criteria (3 listed)
- Patients used illicit drugs
- Patients received heart transplantation
- Patients have the history of arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2011.
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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.
Wen-Je Ko, M.D., Ph.D. study chair
National Taiwan University Hospital
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 Heart Rate Variability, run by National Taiwan University 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 1 inclusion and 3 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 22 Apr 2011. 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 Jin-Ming Wu, M.D. (886-0972653213, kptkptkpt@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 22 Apr 2011.