Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-01-14 @ 2:25 AM
Study NCT ID:
NCT01994928
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2013-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High-flow Nasal Cannula Oxygen.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007440', 'term': 'Intubation'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-31', 'studyFirstSubmitDate': '2013-11-20', 'studyFirstSubmitQcDate': '2013-11-20', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in hemodynamics.', 'timeFrame': 'during intubation and up to 30 minutes after intubation', 'description': 'Changes in mean arterial pressure \\[mmHg\\] measured via arterial line.'}], 'primaryOutcomes': [{'measure': 'Mean decrease in the saturation of oxygen (SpO2) during intubation.', 'timeFrame': 'during intubation', 'description': 'Mean decrease in the saturation of oxygen measured by pulse oximetry (SpO2 \\[%\\]) during intubation.'}], 'secondaryOutcomes': [{'measure': 'Changes in blood gases after intubation.', 'timeFrame': '30 minutes after intubation', 'description': 'Changes in arterial blood gases collected from arterial line (PaO2/FiO2 \\[mmHg\\] and PaCO2 \\[mmHg\\]) after intubation.'}]}, 'conditionsModule': {'conditions': ['Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '27274092', 'type': 'RESULT', 'citation': 'Simon M, Wachs C, Braune S, de Heer G, Frings D, Kluge S. High-Flow Nasal Cannula Versus Bag-Valve-Mask for Preoxygenation Before Intubation in Subjects With Hypoxemic Respiratory Failure. Respir Care. 2016 Sep;61(9):1160-7. doi: 10.4187/respcare.04413. Epub 2016 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'Preoxygenation is routinely performed before endotracheal intubation. In the intensive care unit, preoxygenation is often accomplished using a nose-mouth mask. It seems probable that high flow nasal cannula oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of hypoxemia during intubation. In this prospective randomized study preoxygenation using high flow nasal cannula oxygen is compared with preoxygenation via nose-mouth mask in patients with hypoxemic respiratory failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients treated in an intensive care unit\n* indication for intubation\n* presence of hypoxemic (SaO2/fraction of inspired oxygen(FiO2): 300 or less) respiratory failure\n* informed consent\n\nExclusion Criteria:\n\n* blocked nasopharynx\n* contraindications for nose-mouth mask or high flow nasal cannula oxygen\n* expected difficult airway'}, 'identificationModule': {'nctId': 'NCT01994928', 'briefTitle': 'Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High-flow Nasal Cannula Oxygen.', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Prospective Randomised Study on Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High Flow Nasal Cannula Oxygen.', 'orgStudyIdInfo': {'id': 'PV-4429'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nose-mouth mask', 'description': 'Performance of intubation after preoxygenation using a nose-mouth mask.', 'interventionNames': ['Device: Nose-mouth mask', 'Procedure: Intubation']}, {'type': 'EXPERIMENTAL', 'label': 'High flow nasal cannula oxygen', 'description': 'Performance of intubation after preoxygenation using high flow nasal cannula oxygen.', 'interventionNames': ['Device: High flow nasal cannula oxygen', 'Procedure: Intubation']}], 'interventions': [{'name': 'Nose-mouth mask', 'type': 'DEVICE', 'description': 'Preoxygenation using a nose-mouth mask.', 'armGroupLabels': ['Nose-mouth mask']}, {'name': 'High flow nasal cannula oxygen', 'type': 'DEVICE', 'description': 'Preoxygenation using high flow nasal cannula oxygen.', 'armGroupLabels': ['High flow nasal cannula oxygen']}, {'name': 'Intubation', 'type': 'PROCEDURE', 'description': 'Intubation', 'armGroupLabels': ['High flow nasal cannula oxygen', 'Nose-mouth mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf, Department of Intensive Care Medicine', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Stefan Kluge', 'investigatorFullName': 'Stefan Kluge', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}