Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-02 @ 3:02 AM
Study NCT ID:
NCT05783050
Status:
COMPLETED
Last Update Posted:
2024-08-12
First Post:
2023-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support in Gastrointestinal Endoscopy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D001986', 'term': 'Bronchial Spasm'}, {'id': 'D004844', 'term': 'Epistaxis'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'computer-assisted randomization method'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoxia incidence', 'timeFrame': 'Intra-operative; after device insertion', 'description': 'Hypoxia is defined as SpO2 \\<92% at any time.'}], 'secondaryOutcomes': [{'measure': 'Airway assist maneuver required', 'timeFrame': 'Intra-operative; after device insertion', 'description': 'When the SpO2 value is below 90-92%, airway support maneuvers will be performed'}, {'measure': 'Procedure failure incidence', 'timeFrame': 'Intra-operative; after device insertion', 'description': 'The development of severe hypotension (MAP \\<55 mmHG), bradycardia ( HR\\< 45 bpm) and prolonged deep hypoxia(\\>60 sec SpO2\\<92%) during procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wei Nasal Jet Tube', 'Airway Complication', 'Nasal Cannula Oxygen Support', 'Gastrointestinal Endoscopy', 'sedation'], 'conditions': ['Supraglottic Airway Obstruction', 'Airway Complication of Anesthesia', 'Airway Obstruction', 'Anesthesia Complication', 'Bronchospasm', 'Nasal Bleeding', 'Oxygen Deficiency']}, 'descriptionModule': {'briefSummary': 'Sedoanalgesia is applied to patients during gastrointestinal endoscopy. Sedoanalgesia may cause respiratory depression and hypoxia in patients. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia.This study aimed to compare the efficacy and procedural performance of two different airway devices (Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support) in Gastrointestinal Endoscopy', 'detailedDescription': "Gastrointestinal endoscopy is performed as standard for the diagnosis of many gastrointestinal diseases. During gastrointestinal endoscopy, sedoanalgesia is applied to relieve patients' pain and increase patient comfort. Anesthetic drugs used for sedoanalgesia may cause respiratory depression and hypoxia in patients. Hypoxia resulting from hypoventilation in patients is responsible for many events, including coronary ischemia. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia. The purpose of this procedure is to provide safe oxygenation and ventilation. While providing oxygen support, nasal cannula, classical oxygen mask can be used, as well as new generation oxygenation devices. Our study will show us which method is more beneficial in preventing hypoxia and other side effects, providing comfort for the doctor performing the procedure and for the patient undergoing the procedure. This study aimed to compare the efficacy and procedural performance of two different airway devices (Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support) in Gastrointestinal Endoscopy"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing gastrointestinal endoscopy\n* ASA Physical Status 1-2\n* Body mass index 18.5 - 35 kg/m2\n\nExclusion Criteria:\n\n* High risk of pulmonary aspiration\n\n * Pregnancy\n * Anesthesic drug allergies\n * Difficult airway or facial deformities\n * Height \\<155 cm\n * Alcohol or narcotic drug usage\n * Restrictive or obstructive pulmonary diseases\n * Hepatic cardiac or renal failure\n * Neurologic or cognitive deficiencies.\n * Previous cervical surgery or cervical radiotherapy\n * Previous esophagus surgery\n * Psychotic problems'}, 'identificationModule': {'nctId': 'NCT05783050', 'briefTitle': 'Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support in Gastrointestinal Endoscopy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Comparison of Wei Nasal Jet Tube and Nasal Cannula Oxygen Support Methods in Sedated Gastrointestinal Endoscopy Patients: A Prospective, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Ismail04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Wei Nasal Jet Tube Group (Group W)', 'description': 'After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients.', 'interventionNames': ['Device: Wei Nasal Jet Tube']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nasal Cannula Oxygen Support Group (Group N)', 'description': 'After the induction of anesthesia, the Nasal Cannula Oxygen Cannula was placed in the patients.', 'interventionNames': ['Device: Nasal Cannula Oxygen Support']}], 'interventions': [{'name': 'Wei Nasal Jet Tube', 'type': 'DEVICE', 'description': 'The purpose of this procedure is to provide safe oxygenation and ventilation. While providing oxygen support, nasal cannula, classical oxygen mask can be used, as well as new generation oxygenation devices.', 'armGroupLabels': ['Wei Nasal Jet Tube Group (Group W)']}, {'name': 'Nasal Cannula Oxygen Support', 'type': 'DEVICE', 'description': 'The purpose of this procedure is to provide safe oxygenation and ventilation. While providing oxygen support, nasal cannula, classical oxygen mask can be used, as well as new generation oxygenation devices.', 'armGroupLabels': ['Nasal Cannula Oxygen Support Group (Group N)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'ISMAIL SUMER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem Vakif University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'İsmail SÜMER', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}