UnknownNot Applicable

Non-invasive Cardiac Index in Children

Switzerland55 participantsStarted 2023-10-15

Plain-language 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.

Who can participate

Age range

0 Months – 17 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cardiac output measured by transthoracic electocardiometry ICON®- expressed as L/minutes

Timeframe: During the intraoperative period, up to 30 minutes after anesthesia induction

Cardiac output measured by Transthoracic echocardiography - expressed as L/minutes

Timeframe: During the intraoperative period, up to 30 minutes after anesthesia induction

Estimation of bias between cardiac outputs measured by ICON and Transthoracic echocardiography

Timeframe: During the intraoperative period, up to 30 minutes after anesthesia induction

Trial details

NCT IDNCT06090396

SponsorLaszlo Vutskits

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-10

Contact for this trial

Laszlo Vutskits, MD PhD

+41795533462 laszlo.vutskits@hcuge.ch

View on ClinicalTrials.gov More Cardiac Output trials

Who can participate

Age range

0 Months – 17 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

What they're measuring

Cardiac output measured by transthoracic electocardiometry ICON®- expressed as L/minutes

Timeframe: During the intraoperative period, up to 30 minutes after anesthesia induction

Cardiac output measured by Transthoracic echocardiography - expressed as L/minutes

Timeframe: During the intraoperative period, up to 30 minutes after anesthesia induction

Estimation of bias between cardiac outputs measured by ICON and Transthoracic echocardiography

Timeframe: During the intraoperative period, up to 30 minutes after anesthesia induction