Non-invasive Cardiac Index in Children

NCT06090396 | Unknown

• 1 other identifier: GE 2023-00672
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Output; Anesthesia; Infant ALL

Keywords

hemodynamics; electrical cariometry; non-invasive; infant

Outcome Measures

Primary Outcomes (3)

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

  This parameter is widely used in validation studies aimed to assess cardiac output

  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

  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

  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).

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

Interventions

cardiac output monitoring with electrical cardiometry DIAGNOSTIC_TEST

comparison of limits of agreement between the two monitoring modalities

Also known as: cardiac output monitoring with transthoracic echocardiography

Eligibility Criteria

• Age: 0 Months - 17 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Project population: infants (ASA1-3 status) up to 18 months of age undergoing a surgical procedure under general anaesthesia.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laszlo Vutskits: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Laszlo Vutskits, MD PhD

CONTACT

+41795533462; laszlo.vutskits@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Paediatric Anaesthesia

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 19, 2023
• Study Start: October 15, 2023
• Primary Completion: October 10, 2025
• Study Completion: December 10, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-10

Locations

CH (1)