Clinical trial NCT06688734: Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial
Official title: Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pneumothorax
Trauma
Keywords: traumatic
trauma
pneumothorax
chest tube
duration
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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:

* Does placing chest tubes to water seal initially results in a shorter chest tube duration, without an increase in complications?

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.


Eligibility criteria: Inclusion Criteria:

* admitted to the trauma surgery service
* pneumothorax requiring a chest tube

Exclusion Criteria:

* less than 18 years olf
* pregnant
* prisoner
* greater than 300cc of hemothorax on CT
* chest tube placed prior to CT scan

Primary outcomes:
measure: Chest tube duration
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Change from water seal to suction
timeFrame: Through study completion, an average of 1 year
measure: Additional chest tube placement on affected side
timeFrame: Through study completion, an average of 1 year
measure: Pneumothorax reaccumulation with chest tube to water seal
timeFrame: Through study completion, an average of 1 year
measure: Replacement of chest tube
timeFrame: Through study completion, an average of 1 year
measure: Pneumothorax reaccumulation after chest tube removal
timeFrame: Through study completion, an average of 1 year
measure: Hypoxic events
timeFrame: Through study completion, an average of 1 year
measure: Empyema
timeFrame: Through study completion, an average of 1 year
measure: Pneumonia
timeFrame: Through study completion, an average of 1 year
measure: Retained hemothorax
timeFrame: Through study completion, an average of 1 year
measure: TPA administration
timeFrame: Through study completion, an average of 1 year
measure: Chest tube site, skin and soft tissue infection
timeFrame: Through study completion, an average of 1 year
measure: Video-assisted thoracoscopic surgery
timeFrame: Through study completion, an average of 1 year
measure: Acute respiratory failure requiring intubation
timeFrame: Through study completion, an average of 1 year
measure: Unplanned ICU admission
timeFrame: Through study completion, an average of 1 year
measure: 30-day mortality
timeFrame: Through study completion, an average of 1 year
measure: Length of hospital stay
timeFrame: Through study completion, an average of 1 year
measure: 30-day readmission
timeFrame: Through study completion, an average of 1 year
measure: Thoracic intervention during readmission
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Size of residual pneumothorax on first chest x-ray
timeFrame: Through study completion, an average of 1 year
measure: Presence of air leak each day
timeFrame: Through study completion, an average of 1 year
measure: Number of chest x-rays
timeFrame: Through study completion, an average of 1 year
measure: Number of CT scans of chest after initial imaging
timeFrame: Through study completion, an average of 1 year
measure: Chest tube related costs
timeFrame: Through study completion, an average of 1 year
measure: Mechanical ventilation
timeFrame: Through study completion, an average of 1 year
measure: Length of ICU stay
timeFrame: Through study completion, an average of 1 year
measure: Discharge disposition
timeFrame: Through study completion, an average of 1 year
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.