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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.
The main question it aims to answer is:
Alternating 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Water Seal | Experimental | 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. |
|
| Initial Suction | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inital water seal | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Chest tube duration | Duration of the initial chest tube, measured in hours | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change from water seal to suction | Yes/No | Through study completion, an average of 1 year |
| Additional chest tube placement on affected side | Yes/no |
| Measure | Description | Time Frame |
|---|---|---|
| Size of residual pneumothorax on first chest x-ray | Measured in cm, largest distance from lung edges to chest wall | Through study completion, an average of 1 year |
| Presence of air leak each day | Yes/no Recorded each day there is a chest tube present |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29546613 | Background | 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. | |
| 19999219 | Background | 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. |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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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.
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|
| Initial suction | Procedure | 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. |
|
| Through study completion, an average of 1 year |
| Pneumothorax reaccumulation with chest tube to water seal | Yes/no Yes if growth of pneumothorax on chest x-ray with tube to water seal | Through study completion, an average of 1 year |
| Replacement of chest tube | Yes/no Yes if chest tube removed and then a new one is place on the same side at a later time | Through study completion, an average of 1 year |
| Pneumothorax reaccumulation after chest tube removal | Yes/no Yes if pneumothorax grows on chest x-ray after chest tube removal | Through study completion, an average of 1 year |
| Hypoxic events | Yes/no Yes if <90% O2 saturation is recorded in chart | Through study completion, an average of 1 year |
| Empyema | Yes/no Yes if clinically diagnosed by provider based off of imaging, operative findings, clinical picture, culture results, or operative findings | Through study completion, an average of 1 year |
| Pneumonia | Yes/no Yes if clinically diagnosed and treated for pneumonia | Through study completion, an average of 1 year |
| Retained hemothorax | Yes/no Yes if >300cc hemothorax seen on CT scan after chest tube placement | Through study completion, an average of 1 year |
| TPA administration | Yes/no Yes if any TPA administered to the affected side of the chest | Through study completion, an average of 1 year |
| Chest tube site, skin and soft tissue infection | Yes/no Yes if skin and soft tissue infection treated with incision and drainage, or antibiotics | Through study completion, an average of 1 year |
| Video-assisted thoracoscopic surgery | Yes/no Yes if receives video-assisted thoracoscopic surgery on the affected side during initial admission | Through study completion, an average of 1 year |
| Acute respiratory failure requiring intubation | Yes/no Yes if intubated for hypoxia or hypercapnea during hospital stay | Through study completion, an average of 1 year |
| Unplanned ICU admission | Yes/no Yes if admitted to ICU unexpectedly, for clinical deterioration | Through study completion, an average of 1 year |
| 30-day mortality | Yes/no Yes if died within 30 days of initial presentation | Through study completion, an average of 1 year |
| Length of hospital stay | Integer, measured in days, length of initial hospital stay | Through study completion, an average of 1 year |
| 30-day readmission | Yes/no Yes if readmitted within 30 days of discharge | Through study completion, an average of 1 year |
| Thoracic intervention during readmission | Yes/no Yes if readmitted and receives chest tube, video-assisted thoracoscopic surgery, or thoracotomy on the affected side | Through study completion, an average of 1 year |
| Through study completion, an average of 1 year |
| Number of chest x-rays | Integer, number of chest x-rays after initial trauma evaluation | Through study completion, an average of 1 year |
| Number of CT scans of chest after initial imaging | Integer value Number of CT scans of chest after initial trauma evaluation during hospital stay | Through study completion, an average of 1 year |
| Chest tube related costs | 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 | Through study completion, an average of 1 year |
| Mechanical ventilation | Yes/no Yes if was on mechanical ventilation at any point during hospitalization | Through study completion, an average of 1 year |
| Length of ICU stay | Total times spent in the ICU, measured in days | Through study completion, an average of 1 year |
| Discharge disposition | Categorical Home, inpatient rehab, skilled nursing facility, long term acute care hospital, or died | Through study completion, an average of 1 year |
| Background | 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. |
| 25058250 | Background | 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. |
| 11888968 | Background | 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. |
| 11383809 | Background | 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. |
| 35080596 | Background | 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. |
| 11586158 | Background | 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. |