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 range0 Months – 17 Months

SexALL

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

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 range0 Months – 17 Months

SexALL

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