Clinical Trials Directory

Trials / Completed

CompletedNCT04044157

Cardiac Output in Children During Anesthesia

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

Status
Completed
Phase
Study type
Observational
Enrollment
52 (actual)
Sponsor
Laszlo Vutskits · Academic / Other
Sex
All
Age
17 Months
Healthy volunteers

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

Interventions

TypeNameDescription
OTHERnon-invasive measurement of cardiac outputcardiac output will be non-invasivaly measured by means of electrical cardiometry

Timeline

Start date
2019-09-23
Primary completion
2020-03-17
Completion
2020-03-19
First posted
2019-08-05
Last updated
2020-12-21

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04044157. Inclusion in this directory is not an endorsement.