Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial (SEAL IT)

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.

Study Overview

• Status: Completed
• Conditions: Pneumothorax; Trauma
• Intervention / Treatment: Procedure: Inital water seal; Procedure: Initial suction

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Initial Water Seal; 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; 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.
Experimental: Initial Suction; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest tube duration	Duration of the initial chest tube, measured in hours	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): June 20, 2025

Study Registration Dates

• First Submitted: November 10, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 3, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: trauma; chest tube; duration; pneumothorax; traumatic
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: 241132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No