Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-03 @ 4:15 PM
Study NCT ID:
NCT02167334
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2014-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Positive Pressure Ventilation for Preoxygenation During Panendoscopy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2014-06-11', 'studyFirstSubmitQcDate': '2014-06-17', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'non hypoxemic apnea time', 'timeFrame': 'up to 5 minutes after stopping oxygenation', 'description': 'time the oxygen saturation is going down to 90% during apnea'}], 'secondaryOutcomes': [{'measure': 'surgical laryngoscopy frequency', 'timeFrame': 'up to 15 minutes after stopping oxygenation', 'description': 'number of stopped surgical laryngoscopy because of a low oxygen saturation under 90% with necessity to ventilate the patients during apnea'}, {'measure': 'preoxygenation time', 'timeFrame': 'up to 10 min after the start of oxygenation', 'description': 'time to reach expired oxygen fraction to 90%'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['panendoscopy', 'preoxygenation', 'non invasive ventilation'], 'conditions': ['ENT Cancer Screening']}, 'referencesModule': {'references': [{'pmid': '26716862', 'type': 'RESULT', 'citation': 'Abou-Arab O, Guinot PG, Dimov E, Diouf M, de Broca B, Biet A, Zaatar R, Bernard E, Dupont H, Lorne E. Low-positive pressure ventilation improves non-hypoxaemic apnoea tolerance during ear, nose and throat pan-endoscopy: A randomised controlled trial. Eur J Anaesthesiol. 2016 Apr;33(4):269-74. doi: 10.1097/EJA.0000000000000394.'}]}, 'descriptionModule': {'briefSummary': 'the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy compared to spontaneous breathing preoxygenation.\n\nthe hypothesis is PPV extends the residual functional capacity of lung so it provides more oxygen during apnea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient going for scheduled panendoscopy under general anesthesia\n\nExclusion Criteria:\n\n* BMI upper to 35 kg/m2\n* pregnancy\n* requirement of jet ventilation\n* tracheostomy\n* acute respiratory failure: pneumonia, pulmonary embolism\n* health insurance careless'}, 'identificationModule': {'nctId': 'NCT02167334', 'acronym': 'PANNIV', 'briefTitle': 'Using Positive Pressure Ventilation for Preoxygenation During Panendoscopy.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Non Invasive Ventilation (NIV) Versus Spontaneous Breathing for Preoxygenation During Ear, Nose, and Throat (ENT) Panendoscopy. A Controlled, Prospective, Randomized Study.', 'orgStudyIdInfo': {'id': 'PI12-DR-DIMOV'}, 'secondaryIdInfos': [{'id': '2012-A01053-40', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'positive pressure ventilation', 'description': 'Positive Pressure Ventilation with a 4 cmH2O inhale pressure, a positive end-expiratory pressure of 4 cm H2O, a trigger 2, an inspiratory slope of 0, an inhaled oxygen fraction of 100% administered at a 10 L / min flow.', 'interventionNames': ['Device: positive pressure ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxygenation with simple breathing mask', 'description': 'spontaneously breathing preoxygenation with adapted face mask, to restrict leakage, at 10L/min oxygen, with inhaled fraction of 100% and a 2 L balloon volume.', 'interventionNames': ['Procedure: Oxygenation with simple breathing mask']}], 'interventions': [{'name': 'positive pressure ventilation', 'type': 'DEVICE', 'otherNames': ['non invasive ventilation (NIV)'], 'description': 'Positive Pressure Ventilation with a 4 cmH2O inhale pressure, a positive end-expiratory pressure of 4 cm H2O, a trigger 2, an inspiratory slope of 0, an inhaled oxygen fraction of 100% administered at a 10 L / min flow.', 'armGroupLabels': ['positive pressure ventilation']}, {'name': 'Oxygenation with simple breathing mask', 'type': 'PROCEDURE', 'description': 'Spontaneously breathing preoxygenation with adapted face mask, to restrict leakage, at 10L/min oxygen, with inhaled fraction of 100% and a 2 L balloon volume.', 'armGroupLabels': ['Oxygenation with simple breathing mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Osama ABOU ARAB, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}