Cardiac Output in Children During Anesthesia

Cardiac Output Clinical Trial

— COC  

Official title:

Non-invasive Cardiac Output Monitoring in Children During the Perioperative Period - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044157
• Other study ID #: BASEC 2019-00884
• Status: Completed
• Start date: September 23, 2019
• Est. completion date: March 19, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study investigates cardiac output in young children under 18 months of age during the perioperative period by means of electrical cardiometry.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 19, 2020
• Est. primary completion date: March 17, 2020
• Gender: All
• Age group: N/A to 17 Months

Eligibility

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)

Related Conditions & MeSH terms

• Arterial Hypotension
• Cardiac Output
• Hypotension
• Pediatric Anesthesia
• Perioperative Period

Intervention

Other:
• non-invasive measurement of cardiac output
cardiac output will be non-invasivaly measured by means of electrical cardiometry

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Laszlo Vutskits

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output	Cardiac output will be non-invasivaly measured during the perioperative period by means of electrical electrocardiometry	Measurements start before the induction of anesthesia and ends at emergence from anesthesia
Secondary	Association between cardiac output and blood pressure during anesthesia	Describe how cardiac output and blood pressure are associated in infants during anesthesia	Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia
Secondary	Association between cardiac output and cerebral NIRS during anesthesia	Describe how cardiac output and cerebral NIRS are associated in infants during anesthesia	Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia
Secondary	Association between cardiac output and other anesthesia factors (concentration of anesthetic agent, carbon dioxide) during anesthesia	Describe how cardiac output and other anesthesia factors are associated in infants during anesthesia	Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia