Cardiac OutputDEX-CONCT01001533
Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation
An observational study of Cardiac Output and Sedation, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The aim of the study is to investigate the use of a new FDA-approved non-invasive bio-impedance cardiac monitor, ICON, to detect hemodynamic effects during sedation in children undergoing radiology procedures. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cardiac Output, Sedation
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All pediatric patients (1 month to 18 years of age) eligible for Radiology Sedation Service for CT scan and Nuclear Medicine Scan procedure who agrees to participate in the study will have their vital signs and ICON measurements recorded continuously pre-sedation, during sedation and through recovery until discharge.
Who may be able to join
- All pediatric patients (1 month to 18 years of age)
- Eligible for Radiology Sedation Service for CT scan and Nuclear Medicine
- Scan procedure
Who cannot join
- Pacemakers and Vagus Nerve Stimulator
- Mitral or Aorta Valve Dysfunction
- Dextrocardia
- Second or Third degree heart block
- Current diagnosis of Cardiac, Pulmonary, Hepatic or Renal Failure
- Current diagnosis of pulmonary masses/tumor/pleural effusions/pneumonia/edema
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- Pericardial effusion
- Concomitant use of hypertension medications including ACE inhibitors, beta receptor and calcium channel blockers.
- Large Implanted Metallic Devices (including orthodontic braces, spine rods, plates and screws)
- Allergy to device electrodes
Trial locations and contacts
1 site in 1 country.
United States1 site
Children Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study to Assess the Ability of Non-invasive Bio-impedance Cardiac Monitoring to Detect and Trend Hemodynamic Variables During Dexmedetomidine (DEX) Sedation in Children for Radiology Procedures
The aim of the study is to investigate the use of a new FDA-approved non-invasive bio-impedance cardiac monitor, ICON, to detect hemodynamic effects during sedation in children undergoing radiology procedures. The purpose of the study is to determine the ability of the ICON monitor to identify the anticipated and documented hemodynamic changes in children which occur in response to Dexmedetomidine sedation. The investigators postulate that if the ICON device can trend hemodynamic changes, if any, during dexmedetomidine (DEX) sedation in children the investigators can delineate changes in cardiac output, stroke volume, and systemic vascular resistance associated with observed changes in heart rate and blood pressure.
- Conditions
- Cardiac Output, Sedation
- Keywords
- Electrical Cardiometry, Dexmedetomidine, ICON, bio-impedance, cardiac monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children sedated by DEX | All pediatric patients (1 month to 18 years of age) eligible for Radiology Sedation Service for CT scan and Nuclear Medicine Scan procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim is to ascertain if a decrease in heart rate (HR) with intravenous (IV) DEX is associated with a change in trend of cardiac output (CO) as measured by the ICON device.
Measured: pre-, during, and post sedation
Secondary outcomes (1)
To determine the cardiac parameters provided by the ICON device during changes in blood pressure.
Measured: pre-, during and post sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 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.
- More trials run by Boston Children's 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jackson Wong, Boston Children's Hospital
- Investigators
- Jackson Wong, MD, Principal investigator, Children Hospital Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001533
- Sponsor's protocol ID
- 09-03-0130
- Acronym
- DEX-CO
- Status last verified
- Jun 2011
- First submitted
- 23 Oct 2009
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong J, Steil GM, Curtis M, Papas A, Zurakowski D, Mason KP. Cardiovascular effects of dexmedetomidine sedation in children. Anesth Analg. 2012 Jan;114(1):193-9. doi: 10.1213/ANE.0b013e3182326d5a. Epub 2011 Sep 29.
PubMed 21965374
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Ability of Non-invasive Bio-impedance Cardiac Monitoring to Detect and Trend Hemodynamic Variables During Dexmedetomidine (DEX) Sedation in Children for Radiology Procedures
- ClinicalTrials.gov ID
- NCT01001533
- Acronym / sponsor ID
- DEX-CO / 09-03-0130
- Conditions
- Cardiac Output, Sedation
- Keywords
- Electrical Cardiometry, Dexmedetomidine, ICON, bio-impedance, cardiac monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Oct 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.
The aim of the study is to investigate the use of a new FDA-approved non-invasive bio-impedance cardiac monitor, ICON, to detect hemodynamic effects during sedation in children undergoing radiology procedures. The purpose of the study is to determine the ability of the ICON monitor to identify the anticipated and documented hemodynamic changes in children which occur in response to Dexmedetomidine sedation. The investigators postulate that if the ICON device can trend hemodynamic changes, if any, during dexmedetomidine (DEX) sedation in children the investigators can delineate changes in cardiac output, stroke volume, and systemic vascular resistance associated with observed changes in heart rate and blood pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children sedated by DEX | – | –All pediatric patients (1 month to 18 years of age) eligible for Radiology Sedation Service for CT scan and Nuclear Medicine Scan procedure. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All pediatric patients (1 month to 18 years of age) eligible for Radiology Sedation Service for CT scan and Nuclear Medicine Scan procedure who agrees to participate in the study will have their vital signs and ICON measurements recorded continuously pre-sedation, during sedation and through recovery until discharge.
Key inclusion criteria (3 listed)
- All pediatric patients (1 month to 18 years of age)
- Eligible for Radiology Sedation Service for CT scan and Nuclear Medicine
- Scan procedure
Key exclusion criteria (10 listed)
- Pacemakers and Vagus Nerve Stimulator
- Mitral or Aorta Valve Dysfunction
- Dextrocardia
- Second or Third degree heart block
- Current diagnosis of Cardiac, Pulmonary, Hepatic or Renal Failure
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
The primary aim is to ascertain if a decrease in heart rate (HR) with intravenous (IV) DEX is associated with a change in trend of cardiac output (CO) as measured by the ICON device.
Time frame: pre-, during, and post sedation
1 secondary outcome
To determine the cardiac parameters provided by the ICON device during changes in blood pressure.
Time frame: pre-, during and post sedation
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 5 Jan 2017.
- Derived from this study: PubMed 21965374Wong J, Steil GM, Curtis M, Papas A, Zurakowski D, Mason KP. Cardiovascular effects of dexmedetomidine sedation in children. Anesth Analg. 2012 Jan;114(1):193-9. doi: 10.1213/ANE.0b013e3182326d5a. Epub 2011 Sep 29.
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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.
Jackson Wong, MD principal investigator
Children Hospital Boston
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 and Sedation, run by Boston Children's Hospital 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 3 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 5 Jan 2017. 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?
The primary aim is to ascertain if a decrease in heart rate (HR) with intravenous (IV) DEX is associated with a change in trend of cardiac output (CO) as measured by the ICON device. (time frame: pre-, during, and post sedation). 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 NCT01001533, 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 5 Jan 2017.