Critical IllnessNCT01460329
Comparing Cardiac Output Measurements in Critically Ill Children Using USCOM and Transthoracic ECHO
An observational study of Critical Illness and Pediatrics, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to compare the accuracy and precision of two non-invasive methods of measuring cardiac output in critically ill children (<18 yrs). The participants will include any patient admitted to Pediatric intensive care unit (PICU) requiring a trans-thoracic ECHO (TTE) as part of their treatment… Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Critical Illness, Pediatrics
- What is being tested?
- Ultrasonic Cardiac Output Monitor (USCOM).
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 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 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The subjects for this study can be either male or female and not limited by race or ethnicity. They will include critically ill pediatric patients, less than 18 yrs of age, being treated in the Pediatric intensive care unit.
Who may be able to join
- Any UNC PICU patient <18 yrs requiring a transthoracic ECHO (TTE) as standard of care.
- Gestational age >36 weeks
- Wt > 2 kg
- Written informed parental permission
Who cannot join
- Any patient with known unrepaired intracardiac shunt lesion (ASD,PDA,VSD)
- any post operative patient with delayed closure of chest
- parental refusal to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Children's Hospital
Chapel Hill, North Carolina, 27614
About this study
Official title: Comparing Cardiac Output Measurements in Critically Ill Children Using Ultrasonic Cardiac Output Monitor and Transthoracic Echocardiography.
The purpose of this study is to compare the accuracy and precision of two non-invasive methods of measuring cardiac output in critically ill children (<18 yrs). The participants will include any patient admitted to Pediatric intensive care unit (PICU) requiring a trans-thoracic ECHO (TTE) as part of their treatment plan. Measurements of intermittent cardiac output will be obtained and compared on participants using standard 2-D TTE and Ultrasound Cardiac Output Monitor (USCOM).
- Conditions
- Critical Illness, Pediatrics
- Being tested
- Ultrasonic Cardiac Output Monitor (USCOM).
- Keywords
- intensive care units, pediatric, cardiac index, Doppler Ultrasonography
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Cardiac Output Monitor (USCOM).Device
Also called USCOM
This device is FDA approved and based on the principles of ECHO using continuous-wave Doppler ultrasound to measure cardiac output.
| Study group | Role | What they receive |
|---|---|---|
| USCOM Cardiac index | Not described Receives: Device: Ultrasonic Cardiac Output Monitor (USCOM). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Index
Measured: measured at the time of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Verdino, MD, University of North Carolina, Chapel Hill
- Investigators
- Nina J Verdino, MD, Principal investigator, East Carolina UniversityKeith C Kocis, MD, Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460329
- Sponsor's protocol ID
- 11-1178
- Status last verified
- May 2013
- First submitted
- 24 Oct 2011
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Cardiac Output Measurements in Critically Ill Children Using Ultrasonic Cardiac Output Monitor and Transthoracic Echocardiography.
- ClinicalTrials.gov ID
- NCT01460329
- Acronym / sponsor ID
- 11-1178
- Conditions
- Critical Illness, Pediatrics
- Keywords
- intensive care units, pediatric, cardiac index, Doppler Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Oct 2011 (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.
The purpose of this study is to compare the accuracy and precision of two non-invasive methods of measuring cardiac output in critically ill children (<18 yrs). The participants will include any patient admitted to Pediatric intensive care unit (PICU) requiring a trans-thoracic ECHO (TTE) as part of their treatment plan. Measurements of intermittent cardiac output will be obtained and compared on participants using standard 2-D TTE and Ultrasound Cardiac Output Monitor (USCOM).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| USCOM Cardiac index | – | Device: Ultrasonic Cardiac Output Monitor (USCOM). |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The subjects for this study can be either male or female and not limited by race or ethnicity. They will include critically ill pediatric patients, less than 18 yrs of age, being treated in the Pediatric intensive care unit.
Key inclusion criteria (4 listed)
- Any UNC PICU patient <18 yrs requiring a transthoracic ECHO (TTE) as standard of care.
- Gestational age >36 weeks
- Wt > 2 kg
- Written informed parental permission
Key exclusion criteria (3 listed)
- Any patient with known unrepaired intracardiac shunt lesion (ASD,PDA,VSD)
- any post operative patient with delayed closure of chest
- parental refusal to participate
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 |
|---|---|---|
| Ultrasonic Cardiac Output Monitor (USCOM).Also: USCOMThis device is FDA approved and based on the principles of ECHO using continuous-wave Doppler ultrasound to measure cardiac output. | Device | USCOM Cardiac index |
Primary outcome
Cardiac Index
Time frame: measured at the time of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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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.
Nina J Verdino, MD principal investigator
East Carolina University
Keith C Kocis, MD study chair
University of North Carolina, Chapel Hill
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 Critical Illness and Pediatrics, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 6 May 2013. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Index (time frame: measured at the time of study). 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 6 May 2013.