Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-02 @ 6:56 AM
Study NCT ID:
NCT01869504
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2013-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010996', 'term': 'Pleural Effusion'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2013-02-26', 'studyFirstSubmitQcDate': '2013-05-31', 'lastUpdatePostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of intercostal drains requiring re-siting', 'timeFrame': '7 days', 'description': 'It is likely that most if not all of the drains will have been removed by this time owing to resolution of the effusion, but the time period of 7 days has been selected to allow maximum data capture.'}], 'secondaryOutcomes': [{'measure': 'Patient reported pain scores, using a visual analogue scale', 'timeFrame': 'At 24 hours, 72 hours, and at drain removal, an expected average of 5 days'}, {'measure': 'The frequency of balloon rupture', 'timeFrame': '7 days', 'description': 'It is likely that most if not all of the drains will have been removed by this time owing to resolution of the effusion, but the time period of 7 days has been selected to allow maximum data capture.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ballooned intercostal drain', 'Pleural effusion'], 'conditions': ['Pleural Effusion']}, 'descriptionModule': {'briefSummary': 'Drainage of air and fluid from the chest cavity using plastic tubes (chest drains) is an essential tool in Chest Medicine. A common complication of drain insertion is accidental removal of the drain, usually as a result of inadequate securing techniques, with rates of up to 1 in 5 reported. This often results in the need for further procedures (including drain re-siting), with associated additional risk to the patient and an increase in health care costs. One suggested method to reduce premature drain removal is to use chest drains with ballooned tips, much like a bladder catheter. These would provide a physical obstruction inside the chest cavity at the insertion site, whilst being easy to use as stitching or extensive taping may not be required.\n\nThe investigators propose a trial of a dedicated ballooned chest drain to investigate whether a reduction in drain re-siting rates can be achieved. Pain scores will also be assessed during this trial to ensure that irritation of the lining of the lung or chest wall by the balloon is not excessive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>16 years\n* Able to give written informed consent\n* Requiring intercostal tube drainage of a pleural effusion for clinical reasons\n\nExclusion Criteria:\n\n* Requiring intercostal tube drainage for chest trauma\n* Requiring blunt dissection for drain insertion'}, 'identificationModule': {'nctId': 'NCT01869504', 'briefTitle': 'A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain', 'organization': {'class': 'OTHER', 'fullName': 'Sherwood Forest Hospitals NHS Foundation Trust'}, 'officialTitle': 'A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain', 'orgStudyIdInfo': {'id': 'SFH1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Balloon-tipped intercostal drain', 'description': 'Subjects who have given written informed consent and who fulfill the inclusion and exclusion criteria will proceed to have the study drain inserted at the earliest opportunity as per standard hospital protocols using local anaesthetic, and conscious sedation where appropriate. All other aspects of their treatment will be identical to usual clinical care, including chest drain checks and fluid drainage strategies.', 'interventionNames': ['Device: Balloon-tipped intercostal drain']}], 'interventions': [{'name': 'Balloon-tipped intercostal drain', 'type': 'DEVICE', 'otherNames': ['Manufactured by Rocket Medical.'], 'description': 'Ballooned intercostal drain for pleural effusion, inserted using local anaesthetic and ultrasound guidance.', 'armGroupLabels': ['Balloon-tipped intercostal drain']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG17 4JL', 'city': 'Sutton in Ashfield', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': "King's Mill Hospital", 'geoPoint': {'lat': 53.12542, 'lon': -1.26135}}], 'overallOfficials': [{'name': 'Samuel V Kemp, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sherwood Forest Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherwood Forest Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}