Cardiac Output in Children During Anesthesia

NCT ID: NCT04044157

Last Updated: 2020-12-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2020-03-19

Brief Summary

This study investigates cardiac output in young children under 18 months of age during the perioperative period by means of 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 pediatric cohorts, and electrical cardiometry is now regularly used to monitor cardiac output in the perioperative setting. Nevertheless, the temporal patterns of cardiac output changes in otherwise healthy young children undergoing routine surgical procedures have not been systematically reported. This information is important since it will increase our understanding of hemodynamic changes in small children during anesthesia/surgery and would ultimately lead to a better anesthesia care in this patient population.

The primary objective of this pilot exploratory observational study is to describe temporal patterns of cardiac output in young children ( under18 months of age) during the perioperative period. The secondary objectives are to describe how changes in cardiac output are associated with (i) non-invasively-measured systemic arterial blood pressure; (ii) near-infrared spectroscopy; (iii) other anesthesia factors (arterial oxygen saturation, concentration of anesthesia agents, CO2 levels).

Conditions

Perioperative Period; Cardiac Output; Pediatric Anesthesia; Arterial Hypotension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

non-invasive measurement of cardiac output

cardiac output will be non-invasivaly measured by means of electrical cardiometry

Intervention Type: OTHER

Other Intervention Names

no other intervention

Eligibility Criteria

Inclusion Criteria

• age 0 to 17 months included
• undergo general anesthesia for surgery that is expected to last more than 30 minutes (combines anesthesia and surgical time)
• parental/guardian 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
• history of congenital heart diseases
• known allergy to electrodes' glue
• emergency surgery
• prematurity (born before 37 week PMA)

• Maximum Eligible Age: 17 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laszlo Vutskits

OTHER

Sponsor Role: lead

Responsible Party

Laszlo Vutskits

Head of Pediatric Anesthesia

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Laszlo Vutskits, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hosptials of Geneva

Locations

University Hospitals of Geneva

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

BASEC 2019-00884

Identifier Type: -

Identifier Source: org_study_id