Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 8:03 AM
Study NCT ID:
NCT04044157
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2019-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Output in Children During Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-18', 'studyFirstSubmitDate': '2019-07-31', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac output', 'timeFrame': 'Measurements start before the induction of anesthesia and ends at emergence from anesthesia', 'description': 'Cardiac output will be non-invasivaly measured during the perioperative period by means of electrical electrocardiometry'}], 'secondaryOutcomes': [{'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', 'description': 'Describe how cardiac output and blood pressure are associated in infants during 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', 'description': 'Describe how cardiac output and cerebral NIRS are associated in infants during 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', 'description': 'Describe how cardiac output and other anesthesia factors are associated in infants during anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Period', 'Cardiac Output', 'Pediatric Anesthesia', 'Arterial Hypotension']}, 'descriptionModule': {'briefSummary': 'This study investigates cardiac output in young children under 18 months of age during the perioperative period by means of electrical cardiometry.', 'detailedDescription': '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.\n\nRecent 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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children under 18 months undergoing elective surgery lasting more than 30 minutes.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 0 to 17 months included\n* undergo general anesthesia for surgery that is expected to last more than 30 minutes (combines anesthesia and surgical time)\n* parental/guardian permission (informed consent) obtained\n* ASA 1-3 status\n\nExclusion Criteria:\n\n* structural/anatomical anomaly or other circumstances (e.g. patient positioning) making it difficult to apply the sensors to the body\n* history of congenital heart diseases\n* known allergy to electrodes' glue\n* emergency surgery\n* prematurity (born before 37 week PMA)"}, 'identificationModule': {'nctId': 'NCT04044157', 'acronym': 'COC', 'briefTitle': 'Cardiac Output in Children During Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Non-invasive Cardiac Output Monitoring in Children During the Perioperative Period - a Pilot Study', 'orgStudyIdInfo': {'id': 'BASEC 2019-00884'}}, 'armsInterventionsModule': {'interventions': [{'name': 'non-invasive measurement of cardiac output', 'type': 'OTHER', 'otherNames': ['no other intervention'], 'description': 'cardiac output will be non-invasivaly measured by means of electrical cardiometry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University Hospitals of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Laszlo Vutskits, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hosptials of Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laszlo Vutskits', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Pediatric Anesthesia', 'investigatorFullName': 'Laszlo Vutskits', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}