Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-05 @ 5:41 AM
Study NCT ID:
NCT02528734
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2015-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Needle Exsufflation for 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-19', 'studyFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2015-08-18', 'lastUpdatePostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of patients with pneumothorax recurrence', 'timeFrame': '30 days', 'description': 'Patients will be followed for an expected average of 30 days to identify those with recurrent pneumothorax'}, {'measure': 'Maximal patient self-reported pain during procedure', 'timeFrame': '30 mintutes', 'description': 'patients are asked to assess the maximal pain felt during needle exsufflation or chest tube insertion with the use of a numeric scale from 0 \\[no pain\\] to 10 \\[worst possible pain\\]'}, {'measure': 'Number of patients with treatment-related adverse event', 'timeFrame': '8 days', 'description': 'Patients will be followed for 8 days to identify those with either hemothorax (defined as hematic pleural effusion requiring thoracic drainage); or a vacuo pulmonary edema (defined as occurrence of localised alveolar interstitial opacities on post-procedure chest X-ray); or site of chest tube insertion infection (presence of purulent secretions issuing from chest tube insertion site)'}], 'primaryOutcomes': [{'measure': 'Number of patients with early success of needle exsufflation', 'timeFrame': '24 hrs', 'description': 'success of needle exsufflation is defined as the absence of chest tube insertion requirement within 24hrs following needle exsufflation'}, {'measure': 'Number of patients with early success of needle exsufflation with duration of symptoms prior to exsufflation greater than 48 hrs', 'timeFrame': '24 hrs', 'description': 'success of needle exsufflation is defined as the absence of chest tube insertion requirement within 24hrs following needle exsufflation; duration of symptoms prior to exsufflation is the time (in hrs) elapsed between first chest pain reported by the patient and needle exsufflation'}], 'secondaryOutcomes': [{'measure': 'Length of ICU stay', 'timeFrame': '8 days', 'description': 'participants will be followed for the duration of ICU stay, from ICU admission to ICU discharge, an expected average of 8 days'}, {'measure': 'Length of hospital stay', 'timeFrame': '15 days', 'description': 'participants will be followed for the duration of hospital stay, from hospital admission to hospital discharge, an expected average of 15 days'}, {'measure': 'Number of patients requiring early surgical pleurodesis because of persistent pneumothorax', 'timeFrame': '8 days', 'description': 'Patients will be monitored for eventual need for surgical pleurodesis during their ICU stay because of persistent or worsening pneumothorax'}, {'measure': 'Number of patients with late exsufflation failure', 'timeFrame': '8 days', 'description': 'late exsufflation failure is defined as patients requiring chest tube insertion at least 24 hrs after needle exsufflation because of persistent or worsening of pneumothorax despite initial early success'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pneumothorax'], 'conditions': ['Pneumothorax']}, 'referencesModule': {'references': [{'pmid': '20696690', 'type': 'BACKGROUND', 'citation': 'MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986. No abstract available.'}, {'pmid': '7634863', 'type': 'RESULT', 'citation': 'Andrivet P, Djedaini K, Teboul JL, Brochard L, Dreyfuss D. Spontaneous pneumothorax. Comparison of thoracic drainage vs immediate or delayed needle aspiration. Chest. 1995 Aug;108(2):335-9. doi: 10.1378/chest.108.2.335.'}, {'pmid': '31189731', 'type': 'DERIVED', 'citation': 'Vuillard C, Dib F, Achamlal J, Gaudry S, Roux D, Chemouny M, Javaud N, Dreyfuss D, Ricard JD, Messika J. Longer symptom onset to aspiration time predicts success of needle aspiration in primary spontaneous pneumothorax. Thorax. 2019 Aug;74(8):780-786. doi: 10.1136/thoraxjnl-2019-213168. Epub 2019 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'Monocentric observational study of needle exsufflation for pneumothorax in the ICU.', 'detailedDescription': 'The main objective of this prospective observational non interventional study is to investigate a possible relationship between prior duration of pneumothorax (defined as the duration from first occurence of chest pain reported by patient to exsufflation) and the success of exsufflation procedure (defined by the absence of a chest tube insertion in the following 24h).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients admitted to the ICU with a pneumothorax', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult ICU patients requiring needle exsufflation for spontaneous pneumothorax\n\nExclusion Criteria:\n\n* refuse to participate\n* contraindications to needle exsufflation (acute respiratory failure requiring immediate chest tube insertion)'}, 'identificationModule': {'nctId': 'NCT02528734', 'briefTitle': 'Prospective Evaluation of Needle Exsufflation for Pneumothorax', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Louis Mourier'}, 'officialTitle': 'Impact of Pneumothorax Duration Before Treatment on the Success of Needle Exsufflation', 'orgStudyIdInfo': {'id': 'HLM_JDR5'}}, 'contactsLocationsModule': {'locations': [{'zip': '92700', 'city': 'Colombes', 'country': 'France', 'facility': 'Louis Mourier Hospital', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}], 'overallOfficials': [{'name': 'Ricard Jean-Damien, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hopital Louis Mourier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Louis Mourier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Intensive Care Medicine, Assistant Head of Medico-Surgical ICU', 'investigatorFullName': 'Prof Jean-Damien RICARD', 'investigatorAffiliation': 'Hôpital Louis Mourier'}}}}