NICIM: Non-invasive Cardiac Index in Children

• Sponsor: Laszlo Vutskits (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06090396
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Output; Anesthesia; Infant ALL	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 Design

• Study Type: Observational
• Anticipated Enrollment: 55 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Non-invasive Cardiac Index Monitoring in Young Children During the Perioperative Period: Quantitative Comparison of Electrical Cardiometry and Transthoracic Echocardiography
• Anticipated Study Start Date: Oct 10, 2023
• Anticipated Primary Completion Date: Oct 10, 2025
• Anticipated Study Completion Date: Dec 10, 2025

Outcome Measures

Primary Outcome Measures

1. Cardiac output measured by transthoracic electocardiometry ICON®- expressed as L/min/m2 [During the intraoperative period, up to 30 min after anesthesia induction]

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

2. Cardiac output measured by Transthoracic echocardiography - expressed as L/min/m2 [During the intraoperative period, up to 30 min after anesthesia induction]

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

3. Estimation of bias between cardiac outputs measured by ICON and Transthoracic echocardiography [During the intraoperative period, up to 30 min after anesthesia induction]

   This parameter is widely used in studies comparing accuracy/agreement between two different measurement modalities using the same units of measurements

Secondary Outcome Measures

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 min after anesthesia induction]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Months to 17 Months
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals of Geneva	Geneva		Switzerland	1205

Sponsors and Collaborators

• Laszlo Vutskits

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laszlo Vutskits, Head of Paediatric Anaesthesia, University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT06090396
• Other Study ID Numbers: GE 2023-00672
• First Posted: Oct 19, 2023
• Last Update Posted: Oct 19, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Laszlo Vutskits, Head of Paediatric Anaesthesia, University Hospital, Geneva: hemodynamics; electrical cariometry; non-invasive; infant

Study Results

No Results Posted as of Oct 19, 2023