Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT01170156
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2010-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-04', 'studyFirstSubmitDate': '2010-07-22', 'studyFirstSubmitQcDate': '2010-07-26', 'lastUpdatePostDateStruct': {'date': '2011-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of blue dye in the trachea and/or the bronchi after the suctioning manoeuvre.', 'timeFrame': '48 hours after the beginning of the mechanical ventilation', 'description': 'The cuff pressure will be first checked and reset at 30 cm H2O if needed. Next, blue dye will be instilled just above the cuff through the lumen ending in the subglottic area of the Hi-Lo Evac tube. Then a suctioning manoeuvre will be performed with a suction pressure of - 400 mbar through a 16 French suction catheter. Thereafter, a fiberoptic bronchoscopy will be performed, looking for the presence of blue dye in the trachea and/or the bronchi.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['deep sedation', 'respiratory resuscitation', 'Hi-Lo Evac tube', 'suctioning manoeuvre'], 'conditions': ['Deep Sedation', 'Respiration, Artificial']}, 'referencesModule': {'references': [{'pmid': '23134813', 'type': 'DERIVED', 'citation': 'Beuret P, Philippon B, Fabre X, Kaaki M. Effect of tracheal suctioning on aspiration past the tracheal tube cuff in mechanically ventilated patients. Ann Intensive Care. 2012 Nov 7;2(1):45. doi: 10.1186/2110-5820-2-45.'}]}, 'descriptionModule': {'briefSummary': 'The leakage of oropharyngeal secretions around high-volume low-pressure tracheal tube cuffs is usually considered as a major risk factor for bacterial tracheal colonization and subsequent development of ventilator-associated pneumonia. The rate of leakage around the cuff is related to the pressure differential across the cuff, namely the difference between the pressure of the subglottic fluid above the cuff and the tracheal pressure under the cuff. Consequently, positive end-expiratory pressure (PEEP) improves the sealing around the cuff towards fluid leakage. However, this preventive effect of PEEP is compromised during prolonged mechanical ventilation by tracheal suctioning manoeuvre, which may enhance fluid leakage, by decreasing tracheal pressure. Indeed, in a benchtop model, a suctioning manoeuvre, without disconnection of the ventilator, induced a constant fluid leakage past a high-volume low-pressure tracheal tube cuff when performed with a high level of suction pressure (- 400 mbar) and a large size of suction catheter size (16 French).', 'detailedDescription': 'This clinical study aims to confirm these experimental data in patients under mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intubated with a Hi-Lo Evac tube since less than 48 hours\n* under continuous sedation\n* written consent signed\n\nExclusion Criteria:\n\n* hemodynamic instability\n* allergy of blue dye'}, 'identificationModule': {'nctId': 'NCT01170156', 'briefTitle': 'Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Roanne'}, 'officialTitle': 'Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre', 'orgStudyIdInfo': {'id': '2010REACHR01'}, 'secondaryIdInfos': [{'id': '2010-A00539-30', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Hi-Lo Evac tube (Mallinckrodt Inc, USA) (Instilled blue dye)', 'type': 'DEVICE', 'otherNames': ['Hi-Lo Evac tube (Mallinckrodt Inc, USA)', 'Blue dye 2.5% (Guerbet, France)'], 'description': 'The cuff pressure will be first checked and reset at 30 cm H2O if needed. Next, blue dye will be instilled just above the cuff through the lumen ending in the subglottic area of the Hi-Lo Evac tube. Then a suctioning manoeuvre will be performed with a suction pressure of - 400 mbar through a 16 French suction catheter. Thereafter, a fiberoptic bronchoscopy will be performed, looking for the presence of blue dye in the trachea and/or the bronchi.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '42300', 'city': 'Roanne', 'country': 'France', 'facility': 'CH de Roanne', 'geoPoint': {'lat': 46.03624, 'lon': 4.06802}}], 'overallOfficials': [{'name': 'Pascal BEURET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH de Roanne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Roanne', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Véronique BOURRACHAUT', 'oldOrganization': 'CH de Roanne'}}}}