Cardiac Output in Children During Anesthesia

Completed

• Conditions: Cardiac Output; Pediatric Anesthesia; Arterial Hypotension; Perioperative Period

• Registration Number: NCT04044157
• Lead Sponsor: Laszlo Vutskits

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).

Study Timeline

• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-05
• Study Start: 2019-09-23
• Primary Completion: 2020-03-17
• Study Completion: 2020-03-19
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac output	Measurements start before the induction of anesthesia and ends at emergence from anesthesia	Cardiac output will be non-invasivaly measured during the perioperative period by means of electrical electrocardiometry

Secondary Outcome Measures

Name	Time	Method
Association between cardiac output and other anesthesia factors (concentration of anesthetic agent, carbon dioxide) during anesthesia	Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia	Describe how cardiac output and other anesthesia factors are associated in infants during anesthesia
Association between cardiac output and blood pressure during anesthesia	Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia	Describe how cardiac output and blood pressure are associated in infants during anesthesia
Association between cardiac output and cerebral NIRS during anesthesia	Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia	Describe how cardiac output and cerebral NIRS are associated in infants during anesthesia

Trial Locations

Locations (1)

University Hospitals of Geneva; 🇨🇭 Geneva, Switzerland