Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT06205212
Status:
UNKNOWN
Last Update Posted:
2024-01-12
First Post:
2023-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-flow Nasal Oxygenation During Preoxygenation and Atelectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2024-01-03', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung ultrasound score', 'timeFrame': 'Immediately after anesthesia induction', 'description': 'modified LUSS'}], 'secondaryOutcomes': [{'measure': 'Incidence of atelectasis', 'timeFrame': 'Immediately after anesthesia induction'}, {'measure': 'PaO2 to FiO2 ratio and PaCO2', 'timeFrame': 'Immediately after anesthesia induction'}, {'measure': 'Hemodynamic variables', 'timeFrame': 'During anesthesia induction', 'description': 'Blood pressure, heart rate, pulse oximetry'}, {'measure': 'Patient Satisfaction Score', 'timeFrame': 'During preoxygenation'}, {'measure': 'Lung ultrasound score', 'timeFrame': 'In the PACU after surgery'}, {'measure': 'Incidence of Spo2 less than 95%', 'timeFrame': 'during 48 hours postoperatively'}, {'measure': 'Maximum body temperature', 'timeFrame': 'during hospitalization up to 1 week'}, {'measure': 'Incidence of postoperative pulmonary complications', 'timeFrame': 'during hospitalization up to 1 week'}, {'measure': 'length of hospital stay', 'timeFrame': 'up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia, General', 'Pulmonary Atelectasis']}, 'descriptionModule': {'briefSummary': 'Atelectasis after induction of general anesthesia is common even in healthy patients and is clinically problematic, especially in obese patients. We aim to investigate whether preoxygenation with high-flow nasal oxygen during anesthesia induction reduces atelectasis in obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults patients undergoinig surgery under general anesthesia with a BMI of 30 kg/m2 or greater who have given informed consent\n\nExclusion Criteria:\n\n* surgery time less than 2 hours\n* Nasotracheal intubation\n* Severe cardiac or respiratory disease\n* History of difficult airway\n* History of a surgery or anatomical anomaly in the head and neck\n* History of Inability to breathe through nose\n* Gastric reflux disease'}, 'identificationModule': {'nctId': 'NCT06205212', 'briefTitle': 'High-flow Nasal Oxygenation During Preoxygenation and Atelectasis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of High-flow Nasal Cannula Applied During Preoxygenation for Prevention of Atelectasis in Patients With Obesity Undergoing General Anesthesia: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HFNO_PRE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'facemask', 'description': 'preoxygenation using a conventional facemask', 'interventionNames': ['Other: facemask']}, {'type': 'EXPERIMENTAL', 'label': 'high-flow nasal oxygen', 'description': 'preoxygenation using high-flow nasal cannula oxygen', 'interventionNames': ['Other: high-flow nasal oxygen']}], 'interventions': [{'name': 'high-flow nasal oxygen', 'type': 'OTHER', 'description': 'preoxygenation using high-flow nasal oxygen, FiO2 1.0, 40 L/min, 3 min', 'armGroupLabels': ['high-flow nasal oxygen']}, {'name': 'facemask', 'type': 'OTHER', 'description': 'preoxygenation using facemask, FIO2 1.0, fresh gas flow 10 L/min, 3 min', 'armGroupLabels': ['facemask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07061', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Tae Kyong Kim, MD', 'role': 'CONTACT', 'email': 'ktkktk@gmail.com', 'phone': '82-2-2072-2467'}], 'facility': 'SMG - SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'TAE KYONG KIM', 'role': 'CONTACT', 'email': 'ktkktk@gmail.com', 'phone': '82-2-870-2519'}], 'overallOfficials': [{'name': 'TAE KYONG KIM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}