Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2026-02-18 @ 8:28 AM
Study NCT ID:
NCT06688734
Status:
COMPLETED
Last Update Posted:
2025-08-05
First Post:
2024-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011030', 'term': 'Pneumothorax'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Alternating each month, patients with traumatic pneumothoraces receiving chest tubes will have their chest tubes placed to either water seal or suction initially. The remainder of the chest tube management will be left to the provider.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2024-11-10', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Size of residual pneumothorax on first chest x-ray', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Measured in cm, largest distance from lung edges to chest wall'}, {'measure': 'Presence of air leak each day', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Recorded each day there is a chest tube present'}, {'measure': 'Number of chest x-rays', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Integer, number of chest x-rays after initial trauma evaluation'}, {'measure': 'Number of CT scans of chest after initial imaging', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Integer value Number of CT scans of chest after initial trauma evaluation during hospital stay'}, {'measure': 'Chest tube related costs', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Integer, dollar amount Total cost of chest tube supplies utilized, imaging (chest x-rays plus CT scans of chest), operative room costs if applicable, hospital days'}, {'measure': 'Mechanical ventilation', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if was on mechanical ventilation at any point during hospitalization'}, {'measure': 'Length of ICU stay', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Total times spent in the ICU, measured in days'}, {'measure': 'Discharge disposition', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Categorical Home, inpatient rehab, skilled nursing facility, long term acute care hospital, or died'}], 'primaryOutcomes': [{'measure': 'Chest tube duration', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Duration of the initial chest tube, measured in hours'}], 'secondaryOutcomes': [{'measure': 'Change from water seal to suction', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/No'}, {'measure': 'Additional chest tube placement on affected side', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no'}, {'measure': 'Pneumothorax reaccumulation with chest tube to water seal', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if growth of pneumothorax on chest x-ray with tube to water seal'}, {'measure': 'Replacement of chest tube', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if chest tube removed and then a new one is place on the same side at a later time'}, {'measure': 'Pneumothorax reaccumulation after chest tube removal', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if pneumothorax grows on chest x-ray after chest tube removal'}, {'measure': 'Hypoxic events', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if \\<90% O2 saturation is recorded in chart'}, {'measure': 'Empyema', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if clinically diagnosed by provider based off of imaging, operative findings, clinical picture, culture results, or operative findings'}, {'measure': 'Pneumonia', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if clinically diagnosed and treated for pneumonia'}, {'measure': 'Retained hemothorax', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if \\>300cc hemothorax seen on CT scan after chest tube placement'}, {'measure': 'TPA administration', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if any TPA administered to the affected side of the chest'}, {'measure': 'Chest tube site, skin and soft tissue infection', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if skin and soft tissue infection treated with incision and drainage, or antibiotics'}, {'measure': 'Video-assisted thoracoscopic surgery', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if receives video-assisted thoracoscopic surgery on the affected side during initial admission'}, {'measure': 'Acute respiratory failure requiring intubation', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if intubated for hypoxia or hypercapnea during hospital stay'}, {'measure': 'Unplanned ICU admission', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if admitted to ICU unexpectedly, for clinical deterioration'}, {'measure': '30-day mortality', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if died within 30 days of initial presentation'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Integer, measured in days, length of initial hospital stay'}, {'measure': '30-day readmission', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if readmitted within 30 days of discharge'}, {'measure': 'Thoracic intervention during readmission', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Yes/no Yes if readmitted and receives chest tube, video-assisted thoracoscopic surgery, or thoracotomy on the affected side'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['traumatic', 'trauma', 'pneumothorax', 'chest tube', 'duration'], 'conditions': ['Pneumothorax', 'Trauma']}, 'referencesModule': {'references': [{'pmid': '29546613', 'type': 'BACKGROUND', 'citation': 'Feenstra TM, Dickhoff C, Deunk J. Systematic review and meta-analysis of tube thoracostomy following traumatic chest injury; suction versus water seal. Eur J Trauma Emerg Surg. 2018 Dec;44(6):819-827. doi: 10.1007/s00068-018-0942-7. Epub 2018 Mar 15.'}, {'pmid': '19999219', 'type': 'BACKGROUND', 'citation': 'Muslim M, Bilal A, Salim M, Khan MA, Baseer A, Ahmed M. Tube thorocostomy: management and outcome in patients with penetrating chest trauma. J Ayub Med Coll Abbottabad. 2008 Oct-Dec;20(4):108-11.'}, {'type': 'BACKGROUND', 'citation': 'Majumdar MNI, et al. Role of Continuous low pressure suction in management of traumatic haemothorax and/or haemopneumothorax: experiences at NIDCH and CMH Dhaka. J Armed Forces Med Coll (JAFMC) Bangladesh. 2014;10(2):21-26.'}, {'pmid': '25058250', 'type': 'BACKGROUND', 'citation': 'Morales CH, Mejia C, Roldan LA, Saldarriaga MF, Duque AF. Negative pleural suction in thoracic trauma patients: A randomized controlled trial. J Trauma Acute Care Surg. 2014 Aug;77(2):251-5. doi: 10.1097/TA.0000000000000281.'}, {'pmid': '11888968', 'type': 'BACKGROUND', 'citation': 'Marshall MB, Deeb ME, Bleier JI, Kucharczuk JC, Friedberg JS, Kaiser LR, Shrager JB. Suction vs water seal after pulmonary resection: a randomized prospective study. Chest. 2002 Mar;121(3):831-5. doi: 10.1378/chest.121.3.831.'}, {'pmid': '11383809', 'type': 'BACKGROUND', 'citation': 'Cerfolio RJ, Bass C, Katholi CR. Prospective randomized trial compares suction versus water seal for air leaks. Ann Thorac Surg. 2001 May;71(5):1613-7. doi: 10.1016/s0003-4975(01)02474-2.'}, {'pmid': '35080596', 'type': 'BACKGROUND', 'citation': 'Anderson D, Chen SA, Godoy LA, Brown LM, Cooke DT. Comprehensive Review of Chest Tube Management: A Review. JAMA Surg. 2022 Mar 1;157(3):269-274. doi: 10.1001/jamasurg.2021.7050.'}, {'pmid': '11586158', 'type': 'BACKGROUND', 'citation': 'Di Bartolomeo S, Sanson G, Nardi G, Scian F, Michelutto V, Lattuada L. A population-based study on pneumothorax in severely traumatized patients. J Trauma. 2001 Oct;51(4):677-82. doi: 10.1097/00005373-200110000-00009.'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to compare the effect of placing chest tubes to water seal versus suction initially, in patients with traumatic pneumothoraces, on overall chest tube duration.\n\nThe main question it aims to answer is:\n\n* Does placing chest tubes to water seal initially results in a shorter chest tube duration, without an increase in complications?\n\nAlternating each month, patients' chest tubes will either be placed to water seal or to suction initially. All other management decisions related to the chest tube will be left to the providers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admitted to the trauma surgery service\n* pneumothorax requiring a chest tube\n\nExclusion Criteria:\n\n* less than 18 years olf\n* pregnant\n* prisoner\n* greater than 300cc of hemothorax on CT\n* chest tube placed prior to CT scan'}, 'identificationModule': {'nctId': 'NCT06688734', 'acronym': 'SEAL IT', 'briefTitle': 'Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial', 'orgStudyIdInfo': {'id': '241132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Initial Water Seal', 'description': 'After chest tube placement, the chest tube will be placed to 20cm H2O of suction for 1 minute to evacuate all pneumothorax. After this, the chest tube will be placed to water seal, defined as the water seal chamber on the chest tube drainage system being filled up to the 2cm line and not on suction. All other management decisions related to the chest tube will be left to the providers.', 'interventionNames': ['Procedure: Inital water seal']}, {'type': 'EXPERIMENTAL', 'label': 'Initial Suction', 'description': 'After chest tube placement, the suction group will have their chest tube placed to 20cm H2O of suction delivered by the chest tube drainage suction. All other management decisions related to the chest tube will be left to the providers.', 'interventionNames': ['Procedure: Initial suction']}], 'interventions': [{'name': 'Inital water seal', 'type': 'PROCEDURE', 'description': 'After chest tube placement, the chest tube will be placed to 20cm H2O of suction for 1 minute to evacuate all pneumothorax. After this, the chest tube will be placed to water seal, defined as the water seal chamber on the chest tube drainage system being filled up to the 2cm line and not on suction. All other management decisions related to the chest tube will be left to the providers.', 'armGroupLabels': ['Initial Water Seal']}, {'name': 'Initial suction', 'type': 'PROCEDURE', 'description': 'After chest tube placement, the suction group will have their chest tube placed to 20cm H2O of suction delivered by the chest tube drainage suction. All other management decisions related to the chest tube will be left to the providers.', 'armGroupLabels': ['Initial Suction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Acute Care surgery Clinical Fellow', 'investigatorFullName': 'Eric Yeates', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}