MedDataX Logo

Non-invasive Cardiac Index in Children

NCT ID: NCT06090396

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-15

Study Completion Date

2025-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study investigates the level of agreement of two non-invasive cardiac output monitors (transthoracic echocardiography and electrical cardiometry) in young children under anesthesia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Output Anesthesia Infant ALL

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hemodynamics electrical cariometry non-invasive infant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cardiac output monitoring with electrical cardiometry

comparison of limits of agreement between the two monitoring modalities

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cardiac output monitoring with transthoracic echocardiography

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

0 Months

Maximum Eligible Age

17 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Laszlo Vutskits

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Laszlo Vutskits

Head of Paediatric Anaesthesia

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospitals of Geneva

Geneva, , Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Laszlo Vutskits, MD PhD

Role: CONTACT

Phone: +41795533462

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Laszlo Vutskits, MD PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GE 2023-00672

Identifier Type: -

Identifier Source: org_study_id