AnesthesiologyNCT01678066
A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor
An observational study of Anesthesiology and Pediatrics, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Study hypothesis: The Cardiotronic ICON non-invasive cardiac output monitor gives accurate information when placed on a patient's Right or Left side. Summary: To simultaneously compare physiologic data collected from two non-invasive cardiac output monitors placed bilaterally on pediatric patients undergoing general… Read more about this study
- Who is it for?
- Ages 1 month to 8 years
- Conditions the study is for
- Anesthesiology, Pediatrics, General Surgery
- What is being tested?
- Bilateral cardiac output
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Feb 2013
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients who will undergo general anesthesia in the operating room from age 1 month old to 8 years old with all types of medical conditions who are having lower abdominal and lower extremity surgery in this study so that the additional 8 EKG leads placed on the patients do not interfere with the surgical site or patient positioning.
Who may be able to join
- 1 month old to 8 years old.
- Lower abdominal or lower extremity surgery.
Who cannot join
- Less than 1 month old.
- Greater than 8 years old.
- Patients undergoing upper abdominal, thoracic, upper extremity, or head/neck surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Thomas A Anderson, PhD, MD, 617-724-7247, tanderson9@partners.org
Charles J Cote, MD, 617-724-2250, cjcote@partners.org
About this study
Official title: A Prospective Study to Bilaterally Compare a New FDA-Approved Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia
Study hypothesis: The Cardiotronic ICON non-invasive cardiac output monitor gives accurate information when placed on a patient's Right or Left side.
Summary: To simultaneously compare physiologic data collected from two non-invasive cardiac output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the manufacturer in pediatric and adult patients with leads placed on the left side. However, sometimes the surgical site and/or patient position precludes placement of the monitor leads on the left side. In such situations it would be useful to know whether placement of the monitor's leads on a patient's right side gives accurate cardiac output data. We will prospectively collect, and compare, simultaneous physiologic data for all enrolled children using two monitors, one on the patient's right side and one on the patient's left side.
Read the detailed description
Traditionally cardiac output has been estimated with thermodilution, Fick oxygen consumption or with echocardiography. Other non-invasive techniques such as analysis of arterial wave forms and measurement of expired carbon dioxide have been attempted but with variable success. Recently a new device (Cardiotronic® EC™) has been approved by the FDA for use in children of all ages including neonates. Electrical cardiometry is a new method which can continuously estimate stroke volume and left ventricular outflow to calculate cardiac output, calculate cardiac index, as well as a variety of other parameters through quantitation of changes in impedance associated with changes in the orientation of red blood cells. During diastole red cells are organized chaotically but during systole they assume a position parallel to the direction of blood flow. Thus thoracic electrical bioimpedance relate to changes in thoracic aortic blood flow and through the use of refined algorithms non-invasive measurement of cardiac output is achieved.
The height (cm), gender, weight (kg) and age of the patient are entered into the hand-held device. Eight electrodes are applied to the neck and chest at specified locations, four per device. The device records the heart rate and averages cardiac output every 10-60 heartbeats again depending upon how the device is configured.
This is a prospective, non-randomized study to collect data from two noninvasive FDA-approved cardiac output monitors simultaneously in pediatric patients under general anesthesia in the operating room from age 1 month old to 8 years old with all types of medical conditions. We will enroll 50 male and female pediatric patients who are having lower abdominal and lower extremity surgery in this study so that the additional 8 EKG leads placed on the patients do not interfere with the surgical site or patient positioning.
- Conditions
- Anesthesiology, Pediatrics, General Surgery, Orthopedics, General Anesthesia, Cardiac Output
- Being tested
- Bilateral cardiac output
- Keywords
- Noninvasive cardiac output., Pediatrics.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral cardiac outputDevice
Also called Cardiotronic ICON non-invasive cardiac output monitor
| Study group | Role | What they receive |
|---|---|---|
| Bilateral cardiac output | This is a prospective, non-randomized study to collect data from two noninvasive FDA-approved cardiac output monitors simultaneously in pediatric patients under general anesthesia in the operating room from age 1 month old to 8 years old with all types of medical conditions. We will enroll 50 male and female pediatric patients who are having lower abdominal and lower extremity surgery in this study so that the additional 8 EKG leads placed on the patients do not interfere with the surgical site or patient positioning. Receives: Device: Bilateral cardiac output |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral cardiac output using the Cardiotronic ICON non-invasive cardiac output monitor.
To simultaneously compare physiologic data collected from two non-invasive cardiac output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the manufacturer in pediatric and adult patients with leads placed on the left side. However, sometimes the surgical site and/or patient position precludes placement of the monitor leads on the left side. In such situations it would be useful to know whether placement of the monitor's leads on a patient's right side gives accurate cardiac output data. We will prospectively collect, and compare, simultaneous physiologic data for all enrolled children using two monitors, one on the patient's right side and one on the patient's left side.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startSep 2012
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiologyStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Anthony Anderson, Massachusetts General Hospital
- Investigators
- Thomas A Anderson, PhD, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678066
- Sponsor's protocol ID
- 2012P001561
- Status last verified
- Aug 2012
- First submitted
- 30 Aug 2012
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Suttner S, Schollhorn T, Boldt J, Mayer J, Rohm KD, Lang K, Piper SN. Noninvasive assessment of cardiac output using thoracic electrical bioimpedance in hemodynamically stable and unstable patients after cardiac surgery: a comparison with pulmonary artery thermodilution. Intensive Care Med. 2006 Dec;32(12):2053-8. doi: 10.1007/s00134-006-0409-x. Epub 2006 Oct 13.
PubMed 17039348Norozi K, Beck C, Osthaus WA, Wille I, Wessel A, Bertram H. Electrical velocimetry for measuring cardiac output in children with congenital heart disease. Br J Anaesth. 2008 Jan;100(1):88-94. doi: 10.1093/bja/aem320. Epub 2007 Nov 16.
PubMed 18024954Zoremba N, Bickenbach J, Krauss B, Rossaint R, Kuhlen R, Schalte G. Comparison of electrical velocimetry and thermodilution techniques for the measurement of cardiac output. Acta Anaesthesiol Scand. 2007 Nov;51(10):1314-9. doi: 10.1111/j.1399-6576.2007.01445.x.
PubMed 17944633
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Bilaterally Compare a New FDA-Approved Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT01678066
- Acronym / sponsor ID
- 2012P001561
- Conditions
- Anesthesiology, Pediatrics, General Surgery, Orthopedics, General Anesthesia, Cardiac Output
- Keywords
- Noninvasive cardiac output., Pediatrics.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Study completion
- Feb 2013 (estimated)
- First posted
- 3 Sep 2012 (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.
Study hypothesis: The Cardiotronic ICON non-invasive cardiac output monitor gives accurate information when placed on a patient's Right or Left side.
Summary: To simultaneously compare physiologic data collected from two non-invasive cardiac output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the manufacturer in pediatric and adult patients with leads placed on the left side. However, sometimes the surgical site and/or patient position precludes placement of the monitor leads on the left side. In such situations it would be useful to know whether placement of the monitor's leads on a patient's right side gives accurate cardiac output data. We will prospectively collect, and compare, simultaneous physiologic data for all enrolled children using two monitors, one on the patient's right side and one on the patient's left side.
Detailed description
Traditionally cardiac output has been estimated with thermodilution, Fick oxygen consumption or with echocardiography. Other non-invasive techniques such as analysis of arterial wave forms and measurement of expired carbon dioxide have been attempted but with variable success. Recently a new device (Cardiotronic® EC™) has been approved by the FDA for use in children of all ages including neonates. Electrical cardiometry is a new method which can continuously estimate stroke volume and left ventricular outflow to calculate cardiac output, calculate cardiac index, as well as a variety of other parameters through quantitation of changes in impedance associated with changes in the orientation of red blood cells. During diastole red cells are organized chaotically but during systole they assume a position parallel to the direction of blood flow. Thus thoracic electrical bioimpedance relate to changes in thoracic aortic blood flow and through the use of refined algorithms non-invasive measurement of cardiac output is achieved.
The height (cm), gender, weight (kg) and age of the patient are entered into the hand-held device. Eight electrodes are applied to the neck and chest at specified locations, four per device. The device records the heart rate and averages cardiac output every 10-60 heartbeats again depending upon how the device is configured.
This is a prospective, non-randomized study to collect data from two noninvasive FDA-approved cardiac output monitors simultaneously in pediatric patients under general anesthesia in the operating room from age 1 month old to 8 years old with all types of medical conditions. We will enroll 50 male and female pediatric patients who are having lower abdominal and lower extremity surgery in this study so that the additional 8 EKG leads placed on the patients do not interfere with the surgical site or patient positioning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral cardiac output | – | Device: Bilateral cardiac outputThis is a prospective, non-randomized study to collect data from two noninvasive FDA-approved cardiac output monitors simultaneously in pediatric patients under general anesthesia in the operating room from age 1 month old to 8 years old with all types of medical conditions. We will enroll 50 male and female pediatric patients who are having lower abdominal and lower extremity surgery in this study so that the additional 8 EKG leads placed on the patients do not interfere with the surgical site or patient positioning. |
Who may qualify
- Ages
- 1 month to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients who will undergo general anesthesia in the operating room from age 1 month old to 8 years old with all types of medical conditions who are having lower abdominal and lower extremity surgery in this study so that the additional 8 EKG leads placed on the patients do not interfere with the surgical site or patient positioning.
Key inclusion criteria (2 listed)
- 1 month old to 8 years old.
- Lower abdominal or lower extremity surgery.
Key exclusion criteria (3 listed)
- Less than 1 month old.
- Greater than 8 years old.
- Patients undergoing upper abdominal, thoracic, upper extremity, or head/neck surgery.
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 |
|---|---|---|
| Bilateral cardiac outputAlso: Cardiotronic ICON non-invasive cardiac output monitor | Device | Bilateral cardiac output |
Primary outcome
Bilateral cardiac output using the Cardiotronic ICON non-invasive cardiac output monitor.
Time frame: 6 months
To simultaneously compare physiologic data collected from two non-invasive cardiac output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the manufacturer in pediatric and adult patients with leads placed on the left side. However, sometimes the surgical site and/or patient position precludes placement of the monitor leads on the left side. In such situations it would be useful to know whether placement of the monitor's leads on a patient's right side gives accurate cardiac output data. We will prospectively collect, and compare, simultaneous physiologic data for all enrolled children using two monitors, one on the patient's right side and one on the patient's left side.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
- Background: PubMed 17039348Suttner S, Schollhorn T, Boldt J, Mayer J, Rohm KD, Lang K, Piper SN. Noninvasive assessment of cardiac output using thoracic electrical bioimpedance in hemodynamically stable and unstable patients after cardiac surgery: a comparison with pulmonary artery thermodilution. Intensive Care Med. 2006 Dec;32(12):2053-8. doi: 10.1007/s00134-006-0409-x. Epub 2006 Oct 13.
- Background: PubMed 18024954Norozi K, Beck C, Osthaus WA, Wille I, Wessel A, Bertram H. Electrical velocimetry for measuring cardiac output in children with congenital heart disease. Br J Anaesth. 2008 Jan;100(1):88-94. doi: 10.1093/bja/aem320. Epub 2007 Nov 16.
- Background: PubMed 17944633Zoremba N, Bickenbach J, Krauss B, Rossaint R, Kuhlen R, Schalte G. Comparison of electrical velocimetry and thermodilution techniques for the measurement of cardiac output. Acta Anaesthesiol Scand. 2007 Nov;51(10):1314-9. doi: 10.1111/j.1399-6576.2007.01445.x.
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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.
Thomas A Anderson, PhD, MD principal investigator
Massachusetts General 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 Anesthesiology and Pediatrics, run by Massachusetts General 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 2 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 3 Sep 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas A Anderson, PhD, MD (617-724-7247, tanderson9@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral cardiac output using the Cardiotronic ICON non-invasive cardiac output monitor. (time frame: 6 months). 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 NCT01678066, which also lists 3 linked publications.
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 3 Sep 2012.