Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-04 @ 3:13 PM
Study NCT ID:
NCT02216006
Status:
COMPLETED
Last Update Posted:
2015-05-13
First Post:
2014-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Fresh Gas Flow After Intubation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-12', 'studyFirstSubmitDate': '2014-08-01', 'studyFirstSubmitQcDate': '2014-08-12', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atelectasis', 'timeFrame': 'Within 1-2 hours, just before emergence from anesthesia', 'description': 'The area of atelectasis in the lungs is assessed by computed tomography (CT) 10 mm above the dome of the right diaphragm and expressed in cm2 and as % of the total lung area in the particular scan.'}], 'secondaryOutcomes': [{'measure': 'Arterial blood gases', 'timeFrame': 'Within 2-3 hours perioperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atelectasis', 'Fresh gas flow', 'Prevention', 'Oxygenation', 'Anaesthesia'], 'conditions': ['Atelectasis']}, 'descriptionModule': {'briefSummary': 'Atelectasis is common during and after general anesthesia. Atelectasis develops early if preoxygenation with 100% oxygen is used and continuously used during induction until endotracheal intubation. The investigators hypothesize that a rapid anti-preoxygenation maneuver immediately after confirming a successful intubation, reduces the area of atelectasis as investigated by computed tomography compared to a standard procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy patients, American Society of Anesthesiology (ASA) I-II\n* Patients scheduled for orthopaedic day case surgery in general anaesthesia\n\nExclusion Criteria:\n\n* ASA class III or higher\n* Body Mass Index (BMI) 30 or higher\n* Arterial oxygen saturation (SpO2) \\<94% breathing air\n* Chronic Obstructive Pulmonary Disease (COPD)\n* Ischemic heart disease\n* Haemoglobin \\<100g/L\n* Known or anticipated difficult airway and/or intubation\n* Active smokers and ex-smokers with a history of more than 6 pack years\n* Need for interscalene or supraclavicular regional anaesthesia with risk of phrenic nerve paralysis'}, 'identificationModule': {'nctId': 'NCT02216006', 'briefTitle': 'High Fresh Gas Flow After Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Region Västmanland'}, 'officialTitle': 'High Fresh Gas Flow After Intubation - A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Dnr 2012/335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group, conventional ventilatory settings', 'description': 'Handling of the airway during induction and intubation is performed in a conventional manner.\n\nInitial ventilatory settings are also done in a conventional manner.', 'interventionNames': ['Procedure: Control group, conventional ventilatory settings']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High fresh gas flow, high minute ventilation', 'description': 'Handling of the airway during induction and intubation is performed in a conventional manner.\n\nImmediately after confirming a successful intubation the effect of preoxygenation is eliminated with an anti-preoxygenation maneuver.', 'interventionNames': ['Procedure: High fresh gas flow, high minute ventilation']}], 'interventions': [{'name': 'Control group, conventional ventilatory settings', 'type': 'PROCEDURE', 'description': 'Handling of the airway during induction and intubation is performed in a conventional manner.\n\nInitial ventilatory settings are also done in a conventional manner. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI \\>25) and a respiratory frequency of 10. The fresh gas flow is set to 1 Liter per minute with an oxygen mixture of 40%, aiming for an inspired FiO2 of 30-35%.\n\nUnless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.', 'armGroupLabels': ['Control group, conventional ventilatory settings']}, {'name': 'High fresh gas flow, high minute ventilation', 'type': 'PROCEDURE', 'description': 'Handling of the airway during induction and intubation is performed in a conventional manner.\n\nImmediately after confirming a successful intubation, the effect of preoxygenation is eliminated with a fresh gas flow of 10 L/min of air, delivered with volume controlled ventilation consisting of tidal volumes of approximately 15 ml/kg ideal body weight, a positive expiratory pressure of 10 cm H20 and a respiratory frequency of 10. As soon as the end tidal O2 reaches 25%, the ventilator settings are adjusted to normal values (same as in the control group), i.e. tidal volume 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI \\>25). The mixture of oxygen in the fresh gas is increased to 40% and the fresh gas flow is set to 1 Liter per minute, aiming for an inspired FiO2 of 30-35%.\n\nUnless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure.', 'armGroupLabels': ['High fresh gas flow, high minute ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '731 30', 'city': 'Köping', 'state': 'Västmanland County', 'country': 'Sweden', 'facility': 'Landstinget Västmanland', 'geoPoint': {'lat': 59.51404, 'lon': 15.99255}}], 'overallOfficials': [{'name': 'Mats Enlund, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Landstinget i Värmland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Västmanland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Erland Ostberg', 'investigatorAffiliation': 'Region Västmanland'}}}}