Non-invasive Cardiac Output Monitoring in Children During the Perioperative Period - a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Cardiac output
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 17 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
- Association between cardiac output and other anesthesia factors (concentration of anesthetic agent, carbon dioxide) during anesthesia(Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia)
- Association between cardiac output and blood pressure 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(Time-locked measurements start before the induction of anesthesia and ends at emergence from anesthesia)
Investigators
Laszlo Vutskits
Head of Pediatric Anesthesia
University Hospital, Geneva