Cardiac Output in Children During Anesthesia (COC)

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

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

Study Overview

• Status: Completed
• Conditions: Pediatric Anesthesia; Cardiac Output; Arterial Hypotension; Perioperative Period
• Intervention / Treatment: Other: non-invasive measurement of cardiac output

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 Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children under 18 months undergoing elective surgery lasting more than 30 minutes.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Laszlo Vutskits
• Investigators: Principal Investigator: Laszlo Vutskits, MD PhD, University Hosptials of Geneva

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 23, 2019
• Primary Completion (ACTUAL): March 17, 2020
• Study Completion (ACTUAL): March 19, 2020

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (ACTUAL): August 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: BASEC 2019-00884

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No