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Cardiac Output in Children During Anesthesia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04044157
Acronym
COC
Enrollment
52
Registered
2019-08-05
Start date
2019-09-23
Completion date
2020-03-19
Last updated
2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypotension, Cardiac Output, Pediatric Anesthesia, Perioperative Period

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).

Interventions

OTHERnon-invasive measurement of cardiac output

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

Sponsors

Laszlo Vutskits
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Months

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)

Design outcomes

Primary

MeasureTime frameDescription
Cardiac outputMeasurements start before the induction of anesthesia and ends at emergence from anesthesiaCardiac output will be non-invasivaly measured during the perioperative period by means of electrical electrocardiometry

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026