Skip to main content
OpenTrials
Completed

NCT Number: NCT04044157

Cardiac Output in Children During Anesthesia

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Perioperative Period Arterial Hypotension Cardiac Output Cardiovascular Diseases Hypotension Pediatric Anesthesia Vascular Diseases

Age range

Up to 17 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Geneva

Geneva, 1205, Switzerland

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

non-invasive measurement of cardiac output

Other

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

Other names: no other intervention

Primary outcomes

  1. Cardiac output

    Time frame: 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 outcomes

  1. Association between cardiac output and blood pressure during anesthesia

    Time frame: 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

  2. Association between cardiac output and cerebral NIRS during anesthesia

    Time frame: 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

  3. Association between cardiac output and other anesthesia factors (concentration of anesthetic agent, carbon dioxide) during anesthesia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Laszlo Vutskits

Other

Registry information

Official study title

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

Acronym: COC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2019
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.