Non-invasive Cardiac Index in Children (NICIM)

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.

Study Overview

• Status: Recruiting
• Conditions: Infant ALL; Anesthesia; Cardiac Output
• Intervention / Treatment: Diagnostic test: cardiac output monitoring with electrical cardiometry

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 Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Laszlo Vutskits, MD PhD; Phone Number: +41795533462; Email: laszlo.vutskits@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Recruiting
    • University Hospitals of Geneva
    • Contact: Laszlo Vutskits, MD PhD; Phone Number: +41795533462; Email: laszlo.vutskits@hcuge.ch
    • Principal Investigator: Jeremie Koegel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

1. Age 0 to 17 months included
2. Greater than 36 weeks post-menstrual age (PMA) on the day of the study
3. Undergoing general anaesthesia for surgery that is expected to last more than 30 minutes (combines anaesthesia and surgical time)
4. Parental/guardian understands and reads French and permission (informed consent) obtained
5. ASA 1-3 status

Exclusion Criteria:

1. 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
2. Any Congenital heart diseases
3. Known allergy to electrodes' glue
4. Thoracic, cardiac and head surgery
5. Traumatic surgery with hemodynamic instability

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During the intraoperative period, up to 30 minutes after anesthesia induction

Collaborators and Investigators

• Sponsor: Laszlo Vutskits

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Estimated): October 10, 2025
• Study Completion (Estimated): December 10, 2025

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: non-invasive; hemodynamics; infant; electrical cariometry
• Other Study ID Numbers: GE 2023-00672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No