Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT03976167
Status:
COMPLETED
Last Update Posted:
2019-06-10
First Post:
2019-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-06', 'studyFirstSubmitDate': '2019-05-30', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen desaturation', 'timeFrame': 'Trough study completion, an average of 2 years', 'description': 'Number of patients with Oxygen saturation under 94% during bronchoscopy'}], 'secondaryOutcomes': [{'measure': 'Moderate oxygen desaturations', 'timeFrame': 'Trough study completion, an average of 2 years', 'description': 'Number of patients with Oxygen saturation \\< 94% and \\> 90 %'}, {'measure': 'Severe oxygen desaturations', 'timeFrame': 'Trough study completion, an average of 2 years', 'description': 'Number of patients with Oxygen saturation\\< 90%'}, {'measure': 'Tachypnea', 'timeFrame': 'Trough study completion, an average of 2 years', 'description': 'Number of patients with Breath rate more than p95 fore age for more than 30 seconds'}, {'measure': 'Apnea', 'timeFrame': 'Trough study completion, an average of 2 years', 'description': 'Number of patients with Breath rate 0 for more than 20 seconds or recure intervention'}, {'measure': 'Bradycardia', 'timeFrame': 'Trough study completion, an average of 2 years', 'description': 'Number of patients with Heart rate less than p5 forte age for more than 20 seconds'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Children', 'Desaturations', 'Bronchoscopy', 'Oxygen', 'High flow oxygen'], 'conditions': ['Respiratory Disease']}, 'referencesModule': {'references': [{'pmid': '34506689', 'type': 'DERIVED', 'citation': 'Sharluyan A, Osona B, Frontera G, Brandstrup KB, Figuerola J, Sanz-Ruiz I, Salas A, Garrido B, Eva CG, Fernandez A, Pena-Zarza JA, Gil JA, Bover-Bauza C, Sailer S. High flow nasal cannula versus standard low flow nasal oxygen during flexible bronchoscopy in children: A randomized controlled trial. Pediatr Pulmonol. 2021 Dec;56(12):4001-4010. doi: 10.1002/ppul.25655. Epub 2021 Sep 10.'}]}, 'descriptionModule': {'briefSummary': "Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '29 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective flexible bronchoscopy\n\nExclusion Criteria:\n\n* admitted in Neonatal intensive care\n* previous respiratory support: oxygen any device, non invasive or invasive ventilation\n* patient who may benefit with continuous positive pressure during procedure'}, 'identificationModule': {'nctId': 'NCT03976167', 'briefTitle': 'Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Son Espases'}, 'officialTitle': 'Oxygen Administration During Bronchoscopy in Children, High Flow and Common Nasal Cannula: a Randomized Controled Trial', 'orgStudyIdInfo': {'id': 'IB 3150/16 PI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Common nasal cannula', 'description': 'Oxygen administration up to 4 liters according defined protocol', 'interventionNames': ['Device: Oxygen administration with Common nasal cannula']}, {'type': 'EXPERIMENTAL', 'label': 'High flow nasal cannula', 'description': 'Oxygen administered with high flow nasal cannula according child weight and protocol designed for this study', 'interventionNames': ['Device: Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel']}], 'interventions': [{'name': 'Oxygen administration with Common nasal cannula', 'type': 'DEVICE', 'description': 'Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1.', 'armGroupLabels': ['Common nasal cannula']}, {'name': 'Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel', 'type': 'DEVICE', 'armGroupLabels': ['High flow nasal cannula']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Artur sharluyan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ib-salut'}, {'name': 'Sebastian Sailer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ib-salud'}, {'name': 'Francisco de Borja Osona Rodriguez, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ib-salud'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Son Espases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}