Cardiac OutputNCT00852254
Validation of Minimally Invasive Ultrasound Indicator Dilution Technique in Critically Ill Children
An observational study of Cardiac Output, run by Transonic Systems Inc. at 1 site in United States.
Trial summary
A novel method to measure cardiac index based on ultrasound indicator dilution technology (UIDT) has been developed by Transonic Systems Inc. (Ithaca, NY, USA). The method overcomes many of the limitations that have plagued the existing techniques used to measure cardiac index in critically ill children. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiac Output
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to May 2011
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients (less than 18 years of age) with in situ arterial and central venous catheters.
Who may be able to join
- Age: less than 18 years.
- Admission to the CICU (Cardiac Intensive Care Unit) (8S) or MISICU (Medical-Surgical Intensive Care Unit) (7S) of the Children's Hospital Boston.
- Presence of a central venous catheter with its tip in the superior vena cava or a catheter in the pulmonary artery, documented by radiography.
- Requirement for mechanical ventilation via an endotracheal or tracheostomy tube.
- Presence of an arterial catheter.
- Patients must have a two ventricle circulation.
Who cannot join
- Endotracheal tube leak of greater than 10%.
- A significant air leak around the endotracheal tube makes VO2 impossible to measure.
- Presence of relevant intracardiac shunt.
- Intracardiac shunt will decrease the area under the arterial dilution curve unpredictably, making cardiac index calculations unreliable.
- A patent foramen ovale and a single ventricular septal defect less than or equal to 2mm or an atrial septal defect less than or equal to 3mm will be considered irrelevant for the purposes of this study.
- Previous enrollment in an incompatible research study.
Show all 10Show fewer
- Current or prior diagnosis of heparin induced thrombocytopenia.
- A small amount of heparin is required to flush the extracorporeal AV (Arteriovenous) loop that is required for the measurements.
- Pneumothorax with ongoing air leak.
- An air leak will invalidate the measurement of VO2.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Validation of a Novel, Minimally Invasive Ultrasound Indicator Dilution Technique for Measuring Cardiac Index in Critically Ill Children
A novel method to measure cardiac index based on ultrasound indicator dilution technology (UIDT) has been developed by Transonic Systems Inc. (Ithaca, NY, USA). The method overcomes many of the limitations that have plagued the existing techniques used to measure cardiac index in critically ill children.
In the proposed investigation, the investigators hope to validate a novel application of an existing technology in critically ill infants and children. The primary aim of this study is to determine the accuracy of cardiac index measured by UIDT when compared to the gold-standard Fick technique. The primary hypothesis is that the average of three consecutive measurements of cardiac index by UIDT will be accurate when compared to the Fick technique. Secondary aims will be to determine the precision of the measurement, the feasibility of the technique with regards to time required and any complications encountered. An exploratory secondary aim of this study is to determine whether central blood volume (CBV) derived from indicator transit time (ITT) correlates with central venous pressure (CVP) and echocardiography derived measures of preload.
- Conditions
- Cardiac Output
- Keywords
- Cardiac Index, Ultrasound Dilution, Accuracy of ultrasound dilution cardiac index.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the accuracy of cardiac index measured by ultrasound dilution when compared to the gold-standard Fick technique.
Measured: 5-8 minutes minimum
Secondary outcomes (1)
To determine the precision and feasibility of the measurements. Also to determine whether central blood volume (CBV) measured by ultrasound dilution correlates with central venous pressure (CVP) and echocardiography derived preload measures.
Measured: 5-8 minutes minimum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac OutputStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transonic Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Satish Rajagopal, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852254
- Sponsor's protocol ID
- TSI-C-COSTATUS-6A-H
- Other IDs
- 2R44HL061994-04A2
- Status last verified
- May 2016
- First submitted
- 25 Feb 2009
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.
PubMed 18496416
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel, Minimally Invasive Ultrasound Indicator Dilution Technique for Measuring Cardiac Index in Critically Ill Children
- ClinicalTrials.gov ID
- NCT00852254
- Acronym / sponsor ID
- TSI-C-COSTATUS-6A-H
- Conditions
- Cardiac Output
- Keywords
- Cardiac Index, Ultrasound Dilution, Accuracy of ultrasound dilution cardiac index.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Transonic Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 26 Feb 2009 (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.
A novel method to measure cardiac index based on ultrasound indicator dilution technology (UIDT) has been developed by Transonic Systems Inc. (Ithaca, NY, USA). The method overcomes many of the limitations that have plagued the existing techniques used to measure cardiac index in critically ill children.
In the proposed investigation, the investigators hope to validate a novel application of an existing technology in critically ill infants and children. The primary aim of this study is to determine the accuracy of cardiac index measured by UIDT when compared to the gold-standard Fick technique. The primary hypothesis is that the average of three consecutive measurements of cardiac index by UIDT will be accurate when compared to the Fick technique. Secondary aims will be to determine the precision of the measurement, the feasibility of the technique with regards to time required and any complications encountered. An exploratory secondary aim of this study is to determine whether central blood volume (CBV) derived from indicator transit time (ITT) correlates with central venous pressure (CVP) and echocardiography derived measures of preload.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients (less than 18 years of age) with in situ arterial and central venous catheters.
Key inclusion criteria (6 listed)
- Age: less than 18 years.
- Admission to the CICU (Cardiac Intensive Care Unit) (8S) or MISICU (Medical-Surgical Intensive Care Unit) (7S) of the Children's Hospital Boston.
- Presence of a central venous catheter with its tip in the superior vena cava or a catheter in the pulmonary artery, documented by radiography.
- Requirement for mechanical ventilation via an endotracheal or tracheostomy tube.
- Presence of an arterial catheter.
Key exclusion criteria (10 listed)
- Endotracheal tube leak of greater than 10%.
- A significant air leak around the endotracheal tube makes VO2 impossible to measure.
- Presence of relevant intracardiac shunt.
- Intracardiac shunt will decrease the area under the arterial dilution curve unpredictably, making cardiac index calculations unreliable.
- A patent foramen ovale and a single ventricular septal defect less than or equal to 2mm or an atrial septal defect less than or equal to 3mm will be considered irrelevant for the purposes of this study.
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
To determine the accuracy of cardiac index measured by ultrasound dilution when compared to the gold-standard Fick technique.
Time frame: 5-8 minutes minimum
1 secondary outcome
To determine the precision and feasibility of the measurements. Also to determine whether central blood volume (CBV) measured by ultrasound dilution correlates with central venous pressure (CVP) and echocardiography derived preload measures.
Time frame: 5-8 minutes minimum
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 27 May 2016.
- Background: PubMed 18496416Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.
- Individual participant dataSharing planned: No
Related trials for Cardiac Output
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
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.
Satish Rajagopal, MD principal investigator
Boston Children's 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 Cardiac Output, run by Transonic Systems Inc. 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 6 inclusion and 10 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 27 May 2016. 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?
To determine the accuracy of cardiac index measured by ultrasound dilution when compared to the gold-standard Fick technique. (time frame: 5-8 minutes minimum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00852254, which also lists 1 linked publication.
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 May 2016.