Cardiac OutputNICIMNCT06090396
Non-invasive Cardiac Index in Children
An observational study of Cardiac Output and Anesthesia, run by Laszlo Vutskits at 1 site in Switzerland.
Trial summary
This study investigates the level of agreement of two non-invasive cardiac output monitors (transthoracic echocardiography and electrical cardiometry) in young children under anesthesia. Read more about this study
- Who is it for?
- Ages 0 to 17 months
- Conditions the study is for
- Cardiac Output, Anesthesia, Infant ALL
- What is being tested?
- cardiac output monitoring with electrical cardiometry
- How many people
- 55 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Oct 2023to 10 Dec 2025
- 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 0 to 17 months
- All sexes
- Child
Study population: Project population: infants (ASA1-3 status) up to 18 months of age undergoing a surgical procedure under general anaesthesia.
Who may be able to join
- Age 0 to 17 months included
- Greater than 36 weeks post-menstrual age (PMA) on the day of the study
- Undergoing general anaesthesia for surgery that is expected to last more than 30 minutes (combines anaesthesia and surgical time)
- Parental/guardian understands and reads French and permission (informed consent) obtained
- ASA 1-3 status
Who cannot join
- Structural/anatomical anomaly or other circumstances (e.g., patient positioning) making it difficult to apply the sensors to the body or limiting the feasibility of the TTE
- Any Congenital heart diseases
- Known allergy to electrodes' glue
- Thoracic, cardiac and head surgery
- Traumatic surgery with hemodynamic instability
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospitals of Geneva
Geneva, 1205
Laszlo Vutskits, MD PhD, +41795533462, laszlo.vutskits@hcuge.ch
Jeremie Koegel
About this study
Official title: Non-invasive Cardiac Index Monitoring in Young Children During the Perioperative Period: Quantitative Comparison of Electrical Cardiometry and Transthoracic Echocardiography
This study investigates the level of agreement of two non-invasive cardiac output monitors (transthoracic echocardiography and electrical cardiometry) in young children under anesthesia.
Read the detailed description
Young children are particularly prone to hemodynamic instability during the perioperative period which, in turn, may lead to organ morbidity. Currently, in routine surgical procedures in otherwise healthy children, hemodynamic status in the perioperative period is primarily assessed by non-invasive systemic blood pressure management. While this approach can detect systemic arterial hypotension, it does not provide us with guidance on whether the decrease in blood pressure is the result of changes in cardiac output and/or in systemic vascular resistance. This information would be important to know since treatment modalities may differ.
Recent technical development in electrical cardiometry allows us to non-invasively monitor cardiac output. The accuracy of the method has been validated in neonatal and paediatric cohorts, and electrical cardiometry is now regularly used to monitor cardiac output in the perioperative setting. Nevertheless, the trending patterns of cardiac output in otherwise healthy young children undergoing routine surgical procedures, still need to be described. Due to technical aspects, transthoracic echocardiography is now recognised as "gold-standard" measurement of cardiac output in paediatric patients.
This study is based on a commonly and non-invasively applied monitoring equipment (ICON) which is now regularly used on anesthetized children for the detection of cardiac output during the perioperative period. The primary objective of this validation study is to confirm the non-inferiority of cardiac output measurement with electrical cardiometry versus transthoracic echocardiography in young children ( 0-17 months of age) during the perioperative period.
The secondary objective is to describe the trending aspects of cardiac output during the anaesthesia until the recovery.
- Conditions
- Cardiac Output, Anesthesia, Infant ALL
- Being tested
- cardiac output monitoring with electrical cardiometry
- Keywords
- hemodynamics, electrical cariometry, non-invasive, infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac output monitoring with electrical cardiometryDiagnostic test
Also called cardiac output monitoring with transthoracic echocardiography
comparison of limits of agreement between the two monitoring modalities
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output measured by transthoracic electocardiometry ICON®- expressed as L/minutes
This parameter is widely used in validation studies aimed to assess cardiac output
Measured: During the intraoperative period, up to 30 minutes after anesthesia induction
Cardiac output measured by Transthoracic echocardiography - expressed as L/minutes
This parameter is widely used in validation studies aimed to assess cardiac output
Measured: During the intraoperative period, up to 30 minutes after anesthesia induction
Estimation of bias between cardiac outputs measured by ICON and Transthoracic echocardiography
This statistical description is widely used in studies comparing accuracy/agreement between two different measurement modalities using the same units of measurements; it does not have a physical unit of measure
Measured: During the intraoperative period, up to 30 minutes after anesthesia induction
Secondary outcomes (1)
The secondary endpoints are the bias in the temporal trend of changes between ICON®- and TTE-derived cardiac index values, and the Mean Percentage Error (MPE).
These are statistical parameters and they do not have a physical unit of measure
Measured: During the intraoperative period, up to 30 minutes after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start15 Oct 2023
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laszlo Vutskits
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laszlo Vutskits, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090396
- Sponsor's protocol ID
- GE 2023-00672
- Acronym
- NICIM
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Cardiac Index Monitoring in Young Children During the Perioperative Period: Quantitative Comparison of Electrical Cardiometry and Transthoracic Echocardiography
- ClinicalTrials.gov ID
- NCT06090396
- Acronym / sponsor ID
- NICIM / GE 2023-00672
- Conditions
- Cardiac Output, Anesthesia, Infant ALL
- Keywords
- hemodynamics, electrical cariometry, non-invasive, infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Laszlo VutskitsUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 19 Oct 2023 (actual)
- 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.
This study investigates the level of agreement of two non-invasive cardiac output monitors (transthoracic echocardiography and electrical cardiometry) in young children under anesthesia.
Detailed description
Young children are particularly prone to hemodynamic instability during the perioperative period which, in turn, may lead to organ morbidity. Currently, in routine surgical procedures in otherwise healthy children, hemodynamic status in the perioperative period is primarily assessed by non-invasive systemic blood pressure management. While this approach can detect systemic arterial hypotension, it does not provide us with guidance on whether the decrease in blood pressure is the result of changes in cardiac output and/or in systemic vascular resistance. This information would be important to know since treatment modalities may differ.
Recent technical development in electrical cardiometry allows us to non-invasively monitor cardiac output. The accuracy of the method has been validated in neonatal and paediatric cohorts, and electrical cardiometry is now regularly used to monitor cardiac output in the perioperative setting. Nevertheless, the trending patterns of cardiac output in otherwise healthy young children undergoing routine surgical procedures, still need to be described. Due to technical aspects, transthoracic echocardiography is now recognised as "gold-standard" measurement of cardiac output in paediatric patients.
This study is based on a commonly and non-invasively applied monitoring equipment (ICON) which is now regularly used on anesthetized children for the detection of cardiac output during the perioperative period. The primary objective of this validation study is to confirm the non-inferiority of cardiac output measurement with electrical cardiometry versus transthoracic echocardiography in young children ( 0-17 months of age) during the perioperative period.
The secondary objective is to describe the trending aspects of cardiac output during the anaesthesia until the recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 17 months
- Sex
- All
- Age groups
- Child
- Study population
- Project population: infants (ASA1-3 status) up to 18 months of age undergoing a surgical procedure under general anaesthesia.
Key inclusion criteria (5 listed)
- Age 0 to 17 months included
- Greater than 36 weeks post-menstrual age (PMA) on the day of the study
- Undergoing general anaesthesia for surgery that is expected to last more than 30 minutes (combines anaesthesia and surgical time)
- Parental/guardian understands and reads French and permission (informed consent) obtained
- ASA 1-3 status
Key exclusion criteria (5 listed)
- Structural/anatomical anomaly or other circumstances (e.g., patient positioning) making it difficult to apply the sensors to the body or limiting the feasibility of the TTE
- Any Congenital heart diseases
- Known allergy to electrodes' glue
- Thoracic, cardiac and head surgery
- Traumatic surgery with hemodynamic instability
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 |
|---|---|---|
| cardiac output monitoring with electrical cardiometryAlso: cardiac output monitoring with transthoracic echocardiographycomparison of limits of agreement between the two monitoring modalities | Diagnostic test | – |
Primary outcome
Cardiac output measured by transthoracic electocardiometry ICON®- expressed as L/minutes
Time frame: During the intraoperative period, up to 30 minutes after anesthesia induction
This parameter is widely used in validation studies aimed to assess cardiac output
Cardiac output measured by Transthoracic echocardiography - expressed as L/minutes
Time frame: During the intraoperative period, up to 30 minutes after anesthesia induction
This parameter is widely used in validation studies aimed to assess cardiac output
Estimation of bias between cardiac outputs measured by ICON and Transthoracic echocardiography
Time frame: During the intraoperative period, up to 30 minutes after anesthesia induction
This statistical description is widely used in studies comparing accuracy/agreement between two different measurement modalities using the same units of measurements; it does not have a physical unit of measure
1 secondary outcome
The secondary endpoints are the bias in the temporal trend of changes between ICON®- and TTE-derived cardiac index values, and the Mean Percentage Error (MPE).
Time frame: During the intraoperative period, up to 30 minutes after anesthesia induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Anesthesia, run by Laszlo Vutskits at 1 site in Switzerland.
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 5 inclusion and 5 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 5 Dec 2023. 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 Switzerland. 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 Laszlo Vutskits, MD PhD (+41795533462, laszlo.vutskits@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output measured by transthoracic electocardiometry ICON®- expressed as L/minutes (time frame: During the intraoperative period, up to 30 minutes after anesthesia induction). The study lists 3 primary outcomes in all. 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 5 Dec 2023.