Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 8:07 PM
Study NCT ID:
NCT01008228
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2009-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011030', 'term': 'Pneumothorax'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015505', 'term': 'Chest Tubes'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2009-09-09', 'studyFirstSubmitQcDate': '2009-11-04', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'size of residual pneumothorax measured on chest radiography', 'timeFrame': 'one day'}], 'secondaryOutcomes': [{'measure': 'size of residual pneumothorax at one week', 'timeFrame': 'one week'}, {'measure': 'recidive of pneumothorax at one year', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['spontaneous', 'primary', 'first episode'], 'conditions': ['Pneumothorax']}, 'referencesModule': {'references': [{'pmid': '21277468', 'type': 'BACKGROUND', 'citation': 'Desmettre T, Meurice JC, Kepka S, Dalphin JC. [Treatment of first spontaneous pneumothorax: drainage or exsufflation?]. Rev Mal Respir. 2011 Jan;28(1):5-8. doi: 10.1016/j.rmr.2010.10.028. Epub 2011 Jan 12. No abstract available. French.'}, {'pmid': '21482337', 'type': 'BACKGROUND', 'citation': 'Desmettre T, Meurice JC, Mauny F, Woronoff MC, Tiffet O, Schmidt J, Ferretti G, Dalphin JC. [Comparison of simple aspiration versus standard drainage in the treatment of large primary spontaneous pneumothorax]. Rev Mal Respir. 2011 Mar;28(3):336-43. doi: 10.1016/j.rmr.2010.10.030. Epub 2011 Mar 10. French.'}, {'pmid': '23318185', 'type': 'BACKGROUND', 'citation': 'Desmettre T, Meurice JC, Tapponnier R, Pretalli JB, Dalphin JC. [The EXPRED study: where are we?]. Rev Mal Respir. 2013 Jan;30(1):18-21. doi: 10.1016/j.rmr.2012.09.019. Epub 2012 Nov 13. No abstract available. French.'}, {'pmid': '36693146', 'type': 'DERIVED', 'citation': 'Marx T, Joly LM, Parmentier AL, Pretalli JB, Puyraveau M, Meurice JC, Schmidt J, Tiffet O, Ferretti G, Lauque D, Honnart D, Al Freijat F, Dubart AE, Grandpierre RG, Viallon A, Perdu D, Roy PM, El Cadi T, Bronet N, Duncan G, Cardot G, Lestavel P, Mauny F, Desmettre T. Simple Aspiration versus Drainage for Complete Pneumothorax: A Randomized Noninferiority Trial. Am J Respir Crit Care Med. 2023 Jun 1;207(11):1475-1485. doi: 10.1164/rccm.202110-2409OC.'}]}, 'descriptionModule': {'briefSummary': 'Management of primary spontaneous pneumothorax (PSP) remains unclear. Primary therapeutic goals for PSP include removal of air from the pleural space an prevention of recurrences. The absence of generally accepted and methodologically sound recommendations may account for the extensive variation in practice for air evacuation techniques. Air evacuation may be achieved by simple aspiration (exsufflation) or conventional chest tube drainage. Chest tube thoracotomy remains the most popular technique.Aspiration is a more simple technique, that allows possibility of ambulatory management. The purpose of the present study is to compare simple aspiration performed with a specific thoracentesis device, versus conventional chest tube drainage. Comparison will be performed on immediate efficacity of resolution of the pneumothorax.The hypothesis is that simple aspiration performed with a specific device is not inferior to chest tube drainage for management of a first episode of large size primary spontaneous pneumothorax. A second goal is to measure the efficacy at one week, and the recidive at one year. The trial is randomized, controlled and will include 200 patients for each group. The patients will be enrolled in 29 hospitals in France. Emergency department, thoracic surgery and pulmonary departments of each hospital were primarily contacted for agreement to participate to the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged more than 18 years and less than 50 years\n* first episode of pneumothorax\n* primary pneumothorax (absence of known pulmonary disease)\n* large size of pneumothorax : presence of a visible rim of air between the lund margin and the chest wall, from the apex to pulmonary base\n\nExclusion Criteria:\n\n* impossibility to obtain patient consent for psychiatric disease\n* patients under justice control\n* âgé less than 18 years, or more than 50 years\n* impossibility of medical follow de for geographic, social or psychic reasons\n* pregnant women\n* pneumothorax with acute respiratory insufficiency or bad tolerated\n* recidive of pneumothorax\n* traumatic pneumothorax\n* pneumothorax with pleural effusion\n* bilatéral pneumothorax\n* pneumothorax with pulmonary disease'}, 'identificationModule': {'nctId': 'NCT01008228', 'acronym': 'EXPRED', 'briefTitle': 'Comparison of Exsufflation Versus Drainage in Primary Spontaneous Pneumothorax', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Comparison of Efficacity of Simple Aspiration Versus Standard Drainage in the Management of Large Size Primary Spontaneous Pneumothorax', 'orgStudyIdInfo': {'id': 'R/2009/38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tube thoracic drainage', 'description': 'drainage performed with tube drainage CH 16 or ch 20', 'interventionNames': ['Procedure: thoracic tube drainage']}, {'type': 'EXPERIMENTAL', 'label': 'exsufflation', 'description': 'exsufflation with a specific thoracentesis system', 'interventionNames': ['Procedure: exsufflation']}], 'interventions': [{'name': 'exsufflation', 'type': 'PROCEDURE', 'otherNames': ['Turkel Kit'], 'description': 'exsufflation will be performed with a specific thoracentesis system after introducing the device into chest pneumothorax, aspiration will be performed during 30 minutes', 'armGroupLabels': ['exsufflation']}, {'name': 'thoracic tube drainage', 'type': 'PROCEDURE', 'otherNames': ['Monod Trocar', 'Chest Tube'], 'description': 'thoracic tube drainage will be performed with a tube Ch 16 or ch 20', 'armGroupLabels': ['tube thoracic drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000', 'city': 'Vesoul', 'state': 'Franche Comté', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal de la Haute Saône', 'geoPoint': {'lat': 47.62604, 'lon': 6.14251}}, {'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '15000', 'city': 'Aurillac', 'country': 'France', 'facility': 'Hôpital Henri Mondor', 'geoPoint': {'lat': 44.92539, 'lon': 2.43983}}, {'zip': '90016', 'city': 'Belfort', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '62400', 'city': 'Béthune', 'country': 'France', 'facility': 'CH Bethune', 'geoPoint': {'lat': 50.52965, 'lon': 2.64003}}, {'zip': '62320', 'city': 'Boulogne-sur-Mer', 'country': 'France', 'facility': 'CH Boulogne sur Mer', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21033', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '62110', 'city': 'Hénin-Beaumont', 'country': 'France', 'facility': 'Clinique de HENIN BEAUMONT', 'geoPoint': {'lat': 50.41359, 'lon': 2.96485}}, {'zip': '59160', 'city': 'Lomme', 'country': 'France', 'facility': 'CH Lomme', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '93370', 'city': 'Montfermeil', 'country': 'France', 'facility': 'Chi Le Raincy/Montfermeil', 'geoPoint': {'lat': 48.8982, 'lon': 2.57913}}, {'zip': '68051', 'city': 'Mulhouse', 'country': 'France', 'facility': 'CH Mulhouse', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '66046', 'city': 'Perpignan', 'country': 'France', 'facility': 'CH Perpignan', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '54035', 'city': 'Reims', 'country': 'France', 'facility': 'CHU Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '59100', 'city': 'Roubaix', 'country': 'France', 'facility': 'CHR Roubaix', 'geoPoint': {'lat': 50.69421, 'lon': 3.17456}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'CH Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42050', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37040', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Thibaut TJ Desmettre', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital University of Besancon'}, {'name': 'Thibaut DESMETTRE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Besançon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, {'name': 'Belfort Hospital', 'class': 'OTHER'}, {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, {'name': 'Norman Bethune Medical Hospital', 'class': 'OTHER'}, {'name': 'St Philibert Hospital, Lomme', 'class': 'UNKNOWN'}, {'name': 'Hospital of Montfermeil', 'class': 'UNKNOWN'}, {'name': 'University Hospital, Brest', 'class': 'OTHER'}, {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, {'name': 'Nantes University Hospital', 'class': 'OTHER'}, {'name': 'Association Hospitalière Nord Artois Cliniques', 'class': 'OTHER'}, {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Tours', 'class': 'OTHER'}, {'name': 'CHU de Reims', 'class': 'OTHER'}, {'name': 'Centre hospitalier de Perpignan', 'class': 'OTHER'}, {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, {'name': 'Hospital of Roubaix', 'class': 'UNKNOWN'}, {'name': 'Hospital of Boulogne/mer', 'class': 'UNKNOWN'}, {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, {'name': 'Centre Hospitalier le Mans', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, {'name': 'Hospital of Mulhouse', 'class': 'UNKNOWN'}, {'name': 'Hospital of Valence', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Thibaut Desmettre, MD, PhD', 'investigatorFullName': 'DESMETTRE', 'investigatorAffiliation': 'Centre Hospitalier Universitaire de Besancon'}}}}