Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT01559402
Status:
COMPLETED
Last Update Posted:
2014-09-03
First Post:
2012-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxygenation Test During General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}, {'id': 'C077194', 'term': 'AIEOP acute lymphoblastic leukemia protocol'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-31', 'studyFirstSubmitDate': '2012-03-12', 'studyFirstSubmitQcDate': '2012-03-19', 'lastUpdatePostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in peripheral O2 saturation(SpO2)during and 1 hour after anesthesia in comparison to awake before anesthesia.', 'timeFrame': 'Change in SpO2 from 5 min before start of anesthesia, to 5 min after intubation, 5 min before extubation and 1 hour after extubation.', 'description': 'During anesthesia SpO2 is measured at three different levels of oxygen; 21, 26 and 31 % respectively as long as SpO2 does not go lower than 87 % and compared to SpO2 immediately before anesthesia. SpO2 breathing air one hour after anesthesia is compared to SpO2 before anesthesia.'}], 'secondaryOutcomes': [{'measure': 'Arterial blood gas values for saturation (SaO2)', 'timeFrame': '5 min before anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after anesthesia.', 'description': 'During anesthesia SaO2 is measured at three different levels of oxygen; 21, 26 and 31 % respectively as long as SpO2 (sic! does not go lower than 87 % and compared to SaO2 immediately before anesthesia. SaO2 breathing air one hour after anesthesia is compared to SaO2 before anesthesia.'}, {'measure': 'Arterial oxygen tension (PaO2)', 'timeFrame': '5 min before start of anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after extubation.', 'description': 'During anesthesia PaO2 is measured at three different levels of oxygen; 21, 26 and 31 % respectively as long as SpO2 (sic) does not go lower than 87 % and compared to PaO2 immediately before anesthesia. PaO2 breathing air one hour after anesthesia is compared to PaO2 before anesthesia.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Morbid Obesity']}, 'descriptionModule': {'briefSummary': 'The study investigates if applying a special ventilatory strategy during anesthesia for laparoscopic gastric by pass, produces less atelectasis and better oxygenation in spite of using 100 % oxygen during pre oxygenation and induction of anesthesia. The study investigates oxygenation with blood gas samples but also with a new method that might give more information without the use of blood gas samples.\n\nPrimary: Oxygenation in patients with morbid obesity improves if preoxygenation, induction and maintenance of anesthesia is performed with either a continuous positive airway pressure (CPAP) or a positive end expiratory pressure (PEEP), respectively, of 10 cm H2O, in comparison to a technique without CPAP but with a PEEP of 10 cm H2O.\n\nSecondary: The improved oxygenation during anesthesia can be prolonged inte the postoperative period if emergence from anesthesia is performed without high levels of oxygen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients scheduled for elective surgery of Morbid Obesity.\n* ASA 1-2. (ASA = American Society of Anesthesiologists classification).\n* "Body mass index" (BMI) ≥ 35 but \\< 50\n\nExclusion Criteria:\n\n* "ASA 3"\n* Anticipated difficult intubation.\n* Major bleeding.\n* Problems with ventilation necessitating protocol aberrations.\n* Obstructive sleep apnea syndrome with CPAP treatment at home.\n* Angina Pectoris'}, 'identificationModule': {'nctId': 'NCT01559402', 'briefTitle': 'Oxygenation Test During General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Region Västmanland'}, 'officialTitle': 'Application of Protective Ventilation Improves Oxygenation During and After Anesthesia. Is it Possible That a Special Procedure, an Oxygenation Test, Can Replace Arterial Blood Gases When Evaluating Oxygenation?', 'orgStudyIdInfo': {'id': 'Dnr 2011 / 462'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Start O2 100% and CPAP 10, end O2 100%.', 'description': 'This arm describes some aspects of ventilation during anesthesia for laparoscopic gastric bypass. Pre-oxygenation is with an inspiratory oxygen fraction(FIO2) of 1.0, supplied by a continuous positive airway pressure of 10 centimeters of water(cmH2O), during anesthesia a positive end-expiratory pressure of 10 cmH2O is used and during emergence from anesthesia a FIO2 of 1.0 is used. The intervention associated with this arm is labeled CPAP and 100% oxygen.', 'interventionNames': ['Procedure: CPAP and 100% oxygen']}, {'type': 'EXPERIMENTAL', 'label': 'Start O2 100% and CPAP 10, end O2 31%.', 'description': 'This arm describes some aspects of ventilation during anesthesia for laparoscopic gastric bypass. Pre-oxygenation is with a FIO2 of 1.0, supplied by a continuous positive airway pressure of 10 cmH2O, during anesthesia a positive end-expiratory pressure of 10 cmH2O is used and during emergence from anesthesia a FIO2 of 0.3 is used. The intervention associated with this arm is labeled CPAP and 31% oxygen.', 'interventionNames': ['Procedure: CPAP and 31% oxygen']}, {'type': 'EXPERIMENTAL', 'label': 'Start O2 100% and CPAP 0, end O2 100%.', 'description': 'This arm describes some aspects of ventilation during anesthesia for laparoscopic gastric bypass. Pre-oxygenation is with a FIO2 of 1.0, without a continuous positive airway pressure, during anesthesia a positive end-expiratory pressure of 10 cmH2O is used and during emergence from anesthesia a FIO2 of 1.0 is used. The intervention associated with this arm is labeled No CPAP and 100% oxygen.', 'interventionNames': ['Procedure: No CPAP and 100% oxygen']}], 'interventions': [{'name': 'CPAP and 100% oxygen', 'type': 'PROCEDURE', 'otherNames': ['Preventive ventilation'], 'description': 'During pre oxygenation and induction of anesthesia 100 % oxygen is used with a continuous positive airway pressure of 10 cmH2O, during maintenance of anesthesia a positive endexpiratory pressure of 10 cm H20 is used with controlled volume ventilation aiming at an end tidal carbon dioxide (CO2) level of 5 %. During emergence from anesthesia 100 % oxygen is used.', 'armGroupLabels': ['Start O2 100% and CPAP 10, end O2 100%.']}, {'name': 'CPAP and 31% oxygen', 'type': 'PROCEDURE', 'otherNames': ['Preventive ventilation'], 'description': 'During pre oxygenation and induction of anesthesia 100 % oxygen is used with a continuous positive airway pressure of 10 cm H2O, during maintenance of anesthesia a positive endexpiratory pressure of 10 cm H20 is used with controlled volume ventilation aiming at an end tidal CO2 level of 5 %. During emergence from anesthesia 31 % inspiratory oxygen or the inspiratory oxygen level needed to achieve a SpO2 of at least 96 % (if 31 % oxygen is not enough), is used.', 'armGroupLabels': ['Start O2 100% and CPAP 10, end O2 31%.']}, {'name': 'No CPAP and 100% oxygen', 'type': 'PROCEDURE', 'otherNames': ['Standard protocol.'], 'description': 'This intervention follows a standard protocol without the use CPAP during induction of anesthesia.', 'armGroupLabels': ['Start O2 100% and CPAP 0, end O2 100%.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '721 89', 'city': 'Västerås', 'country': 'Sweden', 'facility': 'Operationskliniken, Västmanlands sjukhus Västerås', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'overallOfficials': [{'name': 'Göran Hedenstierna, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Västmanland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lennart Edmark', 'investigatorAffiliation': 'Region Västmanland'}}}}