Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT03637257
Status:
WITHDRAWN
Last Update Posted:
2020-11-06
First Post:
2018-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbon Dioxide (CO2) Measurement With a CO2/O2 Guedel Airway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001049', 'term': 'Apnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective, randomized, single-blinded cross-over study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'due to other priorities', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2018-08-07', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'end-tidal carbon-dioxide concentration (etCO2)', 'timeFrame': '90 seconds', 'description': 'Difference between capillary and maximum etCO2 sampled via a modified CO2/O2 Guedel airway versus a CO2/O2 nasal cannula'}], 'secondaryOutcomes': [{'measure': 'Change of end-tidal carbon-dioxide concentration (etCO2) according to different oxygen flows (O2)', 'timeFrame': '90 seconds', 'description': 'Effect of O2 administration on etCO2 measurement'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Capnography', 'Pediatric', 'nasal cannula', 'Guedel airway'], 'conditions': ['Breathing Stop']}, 'referencesModule': {'references': [{'pmid': '29757925', 'type': 'BACKGROUND', 'citation': 'Moll J, Anagnostopoulou P, Frei FJ, Erb TO. A modified CO2/O2 Guedel airway improves capnographic accuracy compared with a CO2/O2 nasal cannula: An infant manikin study. Eur J Anaesthesiol. 2018 Aug;35(8):566-572. doi: 10.1097/EJA.0000000000000818.'}]}, 'descriptionModule': {'briefSummary': 'This trial compares capnographic signals using a modified CO2/O2 Guedel airway with a CO2/O2 nasal cannula without and with oxygen supply in sedated children aged 4 - 24 months.', 'detailedDescription': 'Sedation of pediatric patients is frequently jeopardized by respiratory adverse events such as central and/or obstructive apnea resulting in hypoxemia. Various factors such as patient comorbidities, medication and inconsistent physiologic monitoring are known to contribute to or facilitate adverse events during sedation. Therefore, monitoring of breathing by capnography is recommended and has become common standard e.g. by the use of a CO2/O2 nasal cannula.\n\nHowever, capnography derived from CO2/O2 nasal cannulas may be impaired and these impairments are exaggerated in infants based on their physiologic characteristics (small tidal volumes, high respiratory rates).\n\nTo overcome these impairments, the investigators developed a modified CO2/O2 Guedel airway including a CO2 sampling port at the tip of the airway. In a previous study, significantly more accurate capnographic signals resulted compared with measurements derived from a nasal cannula when using a modified CO2/O2 Guedel airway in a model of a breathing 6-month-old manikin.\n\nThe aim of the study is to examine the accuracy of capnographic measurements of the modified CO2/O2 Guedel airway in comparison with measurements from a CO2/O2 nasal cannula in sedated children aged 4 - 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '4 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term born infants aged 4 to 24 months\n* Physical status according classification I or II (American Society of Anaesthesiologists (ASA))\n* Scheduled for elective diagnostic/therapeutic procedures or surgery under sedation/anaesthesia\n* Informed Consent as documented by signature of the parents or legal caregiver\n\nExclusion Criteria:\n\n* syndrome that affects the airway anatomy\n* Physical status according classification III or IV (American Society of Anaesthesiologists (ASA))\n* Upper respiratory tract infection at present or within the last two weeks before the study\n* Previous enrolment into the current study\n* Known hypersensitivity or allergic reactions to midazolam, nitrous oxide (N2O), Propofol or Sevoflurane.\n* Positive Family History for malignant hyperthermia, Morbus Pompe or ophthalmic operations with gas injection or Sinus- or inner ear surgery.'}, 'identificationModule': {'nctId': 'NCT03637257', 'briefTitle': 'Carbon Dioxide (CO2) Measurement With a CO2/O2 Guedel Airway', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Measurement of Expired Carbon Dioxide: Comparison of a Modified CO2/O2 Guedel Airway With a Nasal Cannula in Sedated Children Aged 4-24 Months', 'orgStudyIdInfo': {'id': 'UKBB_Anae_CO2_Gued_Feas'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasal cannula / Guedel', 'description': 'Record of capnography using a standard nasal cannula followed by use of a modified Guedel airway', 'interventionNames': ['Device: modified Guedel airway']}, {'type': 'EXPERIMENTAL', 'label': 'Guedel / nasal cannula', 'description': 'Record of capnography using a modified Guedel airway followed by use of a standard nasal cannula', 'interventionNames': ['Device: modified Guedel airway']}], 'interventions': [{'name': 'modified Guedel airway', 'type': 'DEVICE', 'description': 'Monitoring of breathing', 'armGroupLabels': ['Guedel / nasal cannula', 'Nasal cannula / Guedel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Children´s Hospital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Thomas Erb, Prof. Dr. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UKBB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': "University Children's Hospital Basel", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}