Clinical trial NCT04044157: Cardiac Output in Children During Anesthesia
Official title: Non-invasive Cardiac Output Monitoring in Children During the Perioperative Period - a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Period
Cardiac Output
Pediatric Anesthesia
Arterial Hypotension
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 52
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 18 months undergoing elective surgery lasting more than 30 minutes.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Cardiac output
timeFrame: Measurements start before the induction of anesthesia and ends at emergence from anesthesia
Secondary outcomes:
measure: Association between cardiac output and blood pressure during anesthesia
timeFrame: Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia
measure: Association between cardiac output and cerebral NIRS during anesthesia
timeFrame: Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia
measure: Association between cardiac output and other anesthesia factors (concentration of anesthetic agent, carbon dioxide) during anesthesia
timeFrame: Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
affiliation: University Hosptials of Geneva
name: Laszlo Vutskits, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: