Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-01-05 @ 5:36 PM
Study NCT ID:
NCT03361657
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2017-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2017-11-29', 'studyFirstSubmitQcDate': '2017-11-29', 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between the Arterial to end-tidal carbon dioxide', 'timeFrame': 'Intraoperative', 'description': 'The arterial CO2 will be analysed from the blood gas and the endtidal carbon dioxide will be recorded from the capnography tracing.'}], 'secondaryOutcomes': [{'measure': 'PaCO2-ETCO2 Difference', 'timeFrame': 'Intraoperative', 'description': 'The arterial CO2 will be analysed from the blood gas and the endtidal carbon dioxide will be recorded from capnography.'}, {'measure': 'Heart rate', 'timeFrame': 'Intraoperative', 'description': 'The heart rate will be continuously monitored, intraoperatively'}, {'measure': 'The noninvasive systolic and diastolic arterial blood pressure', 'timeFrame': 'intraoperative', 'description': 'The non invasive systolic and diastolic arterial blood pressure will be recorded at fixed intervals'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraoperative Ventilation']}, 'referencesModule': {'references': [{'pmid': '34411630', 'type': 'DERIVED', 'citation': 'Abdel-Ghaffar HS, Bakr MA, Osman MA, Hanna SGL, Ali WN. End-tidal carbon dioxide measurements as a surrogate to arterial carbon dioxide during pediatric laparoscopic surgeries: a prospective observational cohort study. Braz J Anesthesiol. 2024 Sep-Oct;74(5):744261. doi: 10.1016/j.bjane.2021.07.036. Epub 2021 Aug 16.'}]}, 'descriptionModule': {'briefSummary': 'Studying the arterial to end-tidal carbon dioxide difference in children undergoing laparoscopic surgeries under different intra-abdominal pressures is of extreme importance. This is because both hyper and hypocarbia are detrimental in this vulnerable age group.', 'detailedDescription': 'Capnography provides a non-invasive estimate of arterial CO2 levels and allows clinicians to modify mechanical ventilation settings in order to maintain normocapnia. Normally, a positive gap between arterial CO2 and ETCO2 of approximately 0.5 kPa is assumed in a healthy patient and ventilation settings are adjusted accordingly. However, the correlation between PaCO2 and PetCO2 during laparoscopic surgery is inconsistent mainly due to inter- and intra-individual variability. Discrepancies between arterial carbon dioxide and End-tidal carbon dioxide measures have been demonstrated in ventilated children with cyanotic congenital heart disease , infants with respiratory failure and during visceral and urological laparoscopic surgery. Moreover, as the increase in PaCO2 is directly proportional to the level of intra-abdominal pressure (IAP) used, variations in the arterial to end-tidal carbon dioxide difference can be also expected with different levels of IAP used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children scheduled for laparoscopic surgery of Weight: 10-30 kg, Age: 1-6 years, both males and females,ASA physical status: I, II.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with the following inclusion criteria;\n* Weight: 10-30 kg.\n* Age: 1-6 years.\n* Sex: both males and females.\n* ASA physical status: I, II.\n* Operation: elective laparoscopic surgeries that last more than 45 min.\n\nExclusion Criteria:\n\nPatients will be excluded if they have;\n\n* Patients with any perioperative cardiovascular or respiratory event occurred which made the study intervention clinically unacceptable,\n* Patients with unsatisfactory preoperative peripheral arterial oxygen saturation,\n* Patients with unsatisfactory preoperative hemoglobin level, neurological or psychiatric disease,\n* Children with a BMI \\>95th percentile for age.'}, 'identificationModule': {'nctId': 'NCT03361657', 'acronym': 'PaCO2-EtCO2', 'briefTitle': 'Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Arterial to End-Tidal Carbon Dioxide Difference During Pediatric Laparoscopic Surgeries', 'orgStudyIdInfo': {'id': '17300081'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'One sample', 'description': 'Laparoscopic surgeries will be performed according to the standard surgical and anesthesia protocols. Pneumo-peritoneum will be achieved using non-heated non-humidified CO2 with the intra-abdominal pressure (IAP) maintained at 10-12mmHg'}]}, 'contactsLocationsModule': {'locations': [{'zip': '715715', 'city': 'Asyut', 'state': 'Assiut Governorate', 'country': 'Egypt', 'facility': 'Assiut university Pediatric hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Hala Abdelghaffar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'professor in Anesthesia department, faculty of medicine, Assiut university, Assiut, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Hala Saad Abdel-Ghaffar', 'investigatorAffiliation': 'Assiut University'}}}}