Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2026-03-01 @ 9:55 PM
Study NCT ID:
NCT03823716
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2019-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inadvertent Hyperventilation During Intraoperative Care in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-14', 'studyFirstSubmitDate': '2019-01-23', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased Partial Pressure of Carbon Dioxide (PaCO2)', 'timeFrame': 'During surgical procedure (average of 2-3 hours)', 'description': 'PaCO2 from arterial blood gas (ABG) ≤ 35'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Disorder']}, 'referencesModule': {'references': [{'pmid': '32184375', 'type': 'DERIVED', 'citation': 'Chenault K, Wakimoto M, Miller R, Tobias JD. The Incidence and Severity of Hypocarbia in Neonates Undergoing General Anesthesia. Respir Care. 2020 Aug;65(8):1154-1159. doi: 10.4187/respcare.07382. Epub 2020 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'In order to evaluate current anesthetic practice in the care of preterm infants and neonates, the investigators will retrospectively review surgical procedures in infants who are less than 60 weeks post-conceptual age in which an arterial cannula was placed intraoperatively or in situ upon arrival in the operating room. They will evaluate the mode of ventilation (pressure or volume-controlled), tidal volume or peak inflating pressure, the level of PEEP, inspired oxygen concentration (FiO2), and respiratory rate used during the procedure to determine the average minute ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients seen at Nationwide Children's Hospital.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* neonates (\\<60 weeks post-conceptual age) undergoing non-cardiac operative procedures in which arterial access is generally present (exploratory laparotomy or thoracotomy)\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03823716', 'briefTitle': 'Inadvertent Hyperventilation During Intraoperative Care in Neonates', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Inadvertent Hyperventilation During Intraoperative Care in Neonates', 'orgStudyIdInfo': {'id': 'IRB17-00032'}}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Kristin Chenault, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor of Anesthesiology', 'investigatorFullName': 'Kristin Chenault', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}