Cardiac Output in Children During Anesthesia
COC
Non-invasive Cardiac Output Monitoring in Children During the Perioperative Period - a Pilot Study
1 other identifier
observational
52
1 country
1
Brief Summary
This study investigates cardiac output in young children under 18 months of age during the perioperative period by means of electrical cardiometry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedStudy Start
First participant enrolled
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2020
CompletedDecember 21, 2020
December 1, 2020
6 months
July 31, 2019
December 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Cardiac output
Cardiac output will be non-invasivaly measured during the perioperative period by means of electrical electrocardiometry
Measurements start before the induction of anesthesia and ends at emergence from anesthesia
Secondary Outcomes (3)
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
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
Interventions
cardiac output will be non-invasivaly measured by means of electrical cardiometry
Eligibility Criteria
Children under 18 months undergoing elective surgery lasting more than 30 minutes.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laszlo Vutskitslead
Study Sites (1)
University Hospitals of Geneva
Geneva, 1205, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laszlo Vutskits, MD PhD
University Hosptials of Geneva
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of Pediatric Anesthesia
Study Record Dates
First Submitted
July 31, 2019
First Posted
August 5, 2019
Study Start
September 23, 2019
Primary Completion
March 17, 2020
Study Completion
March 19, 2020
Last Updated
December 21, 2020
Record last verified: 2020-12