Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-07 @ 3:57 AM
Study NCT ID:
NCT05659758
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2022-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Effective Preoxygenation in Elderly Patients Related to Position?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2022-12-11', 'studyFirstSubmitQcDate': '2022-12-20', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time ETO2 85%', 'timeFrame': 'Time between placement of face mask and end tidal oxygen concentration reaches 85 %', 'description': 'Time to reach ETO2 85 %'}], 'secondaryOutcomes': [{'measure': 'Desaturation time', 'timeFrame': 'Time between initiation laryngoscopy for endotracheal intubation and peripheral oxygen saturation reaches 92 % measured by pulseoxymeter', 'description': 'Time to reach the Spo2 of 92 % after intubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preoxygenation, elderly'], 'conditions': ['Anesthesia Intubation Complication']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of the head-up position of 20 and 30 degrees on the ETO2 reaching time of 85% and the desaturation time of 92% after intubation in elderly patients compared to the supine position.', 'detailedDescription': "Patients will be randomized into 3 groups. The patients will lay in the supine position, in the control group and 20 and 30 degrees head up position in other two groups. Each patient will be preoxygenated with well fitting anaesthesia face mask with FiO2 of 100% at least 6L of flow until the ETO2 reaches concentration of 85%. The angle (20 or 30 degrees) formed by the patients' bodies (hips and feet parallel to the ground, lifting the back from the ground plane) with the ground will be measured with a spirit level, angle meter, and confirmed with a smartphone application. The time to reach ETO2 85% by starting preoxygenation in patients will be measured and recorded with a stopwatch. When the target is reached, anesthesia induction will be performed and the patients will be intubated. After the start of the intubation attempt, the stopwatch will be started again, after intubation, the patient will be ventilated with a balloon once and the location of the tube will be confirmed, the circuit will be separated and SpO2 will be expected to go down to the level of 92 % and recorded during this time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 65 years\n* ASA 1-2\n\nExclusion Criteria:\n\n* heart failure\n* uncooperative\n* patients refusing well fitting face mask before reaching EtO2 85%\n* chronic lung disease\n* anemia (hb\\<8gr/dl)\n* BMI\\>40\n* neurological sequela'}, 'identificationModule': {'nctId': 'NCT05659758', 'briefTitle': 'Is Effective Preoxygenation in Elderly Patients Related to Position?', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Is Effective Preoxygenation in Elderly Patients Related to Position?', 'orgStudyIdInfo': {'id': 'E1-22-2775'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'control', 'description': 'patients will be preoxygenated in supine position', 'interventionNames': ['Procedure: Head up positioning during preoxygenation']}, {'type': 'EXPERIMENTAL', 'label': '20 degree', 'description': 'patients will be preoxygenated in 20 degrees head up position', 'interventionNames': ['Procedure: Head up positioning during preoxygenation']}, {'type': 'EXPERIMENTAL', 'label': '30 degree', 'description': 'patients will be preoxygenated in 30 degrees head up position', 'interventionNames': ['Procedure: Head up positioning during preoxygenation']}], 'interventions': [{'name': 'Head up positioning during preoxygenation', 'type': 'PROCEDURE', 'description': 'patients will be preoxygenated in head up position', 'armGroupLabels': ['20 degree', '30 degree', 'control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology and Reanimation, Principle Investigator', 'investigatorFullName': 'Namik ozcan', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}