Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial

NCT06688734 | Completed

• 1 other identifier: 241132
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumothorax; Trauma

Keywords

traumatic; trauma; pneumothorax; chest tube; duration

Outcome Measures

Primary Outcomes (1)

• Chest tube duration

  Duration of the initial chest tube, measured in hours

  Through study completion, an average of 1 year

Secondary Outcomes (18)

• Change from water seal to suction

  Through study completion, an average of 1 year

• Additional chest tube placement on affected side

  Through study completion, an average of 1 year

• Pneumothorax reaccumulation with chest tube to water seal

  Through study completion, an average of 1 year

• Replacement of chest tube

  Through study completion, an average of 1 year

• Pneumothorax reaccumulation after chest tube removal

  Through study completion, an average of 1 year

Other Outcomes (8)

• Size of residual pneumothorax on first chest x-ray

  Through study completion, an average of 1 year

• Presence of air leak each day

  Through study completion, an average of 1 year

• Number of chest x-rays

  Through study completion, an average of 1 year

Study Arms (2)

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.

Procedure: Inital water seal

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.

Procedure: Initial suction

Interventions

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.

Initial Water Seal

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.

Initial Suction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (8)

• 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: 29546613 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.

  PMID: 19999219 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.

  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.

  PMID: 25058250 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.

  PMID: 11888968 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.

  PMID: 11383809 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.

  PMID: 35080596 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.

  PMID: 11586158 BACKGROUND

MeSH Terms

Conditions

Pneumothorax; Wounds and Injuries

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acute Care surgery Clinical Fellow

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 14, 2024
• Study Start: October 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 20, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)