Suction vs Underwater Seal for HemoPneumoThoraX Trial

NCT07551791 | Recruiting DMC

• 1 other identifier: 251524
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic pneumothorax and hemothorax are common consequences of chest injury, often requiring prompt tube thoracostomy to re-expand the lung and drain accumulated blood or air. Current practice varies widely regarding whether chest tubes should initially be placed to suction or to water seal, and prior studies have reported mixed findings. While suction may theoretically improve drainage and lung expansion, some studies suggest it may prolong air leaks and chest tube duration. Conversely, initial water seal has been associated with shorter tube duration without an increase in complications. The predecessor to this trial, the SEAL IT Trial, demonstrated that water seal reduced chest tube duration in patients with pneumothorax without an increase in complication, but excluded those with significant hemothorax. This single-center, randomized controlled trial (SUS-HPTX) will expand upon those findings by evaluating the effect of initial chest tube management strategy, suction versus water seal, in trauma patients with hemopneumothorax or hemothorax. Patients will be assigned to one of the two groups based on calendar month of enrollment, with clinicians able to adjust management as needed. The primary outcome is chest tube duration. Secondary outcomes include chest tube-related complications (e.g., empyema, pneumonia, re-accumulation of pneumothorax or hemothorax, need for additional procedures), hospital length of stay, readmissions, and mortality. Because both suction and water seal are accepted standards of care, the study involves minimal incremental risk. Findings will expand prior evidence and inform best practices for chest tube management in trauma

Conditions

Hemothorax; Traumatic; Hemopneumothorax; Traumatic

Keywords

traumatic; hemothorax; hemopneumothorax; thoracostomy tube

Outcome Measures

Primary Outcomes (1)

• Chest tube duration

  hours from placement of chest tube to removal of chest tube, on average 3 days

Study Arms (2)

Even months

EXPERIMENTAL

Other: Suction

Odd months

EXPERIMENTAL

Other: Water Seal

Interventions

Suction OTHER

Initial chest tube placed to suction

Even months

Water Seal OTHER

Initial chest tube placed to water seal

Odd months

Eligibility Criteria

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

You may qualify if:

• Admitted to trauma service
• Patient has hemothorax or hemopneumothorax requiring chest tube

You may not qualify if:

• Less than 18 years old, pregnant, prisoner, 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

RECRUITING

Related Publications (9)

• Priyadarshi A, Gupta S, Priyadarshini P, Kumar A, Alam J, Bagaria D, Choudhary N, Sagar S, Gupta A, Mishra B, Pandey S, Kumar S. Role of low-pressure negative pleural suction in patients with thoracic trauma - a randomized controlled trial. Eur J Trauma Emerg Surg. 2024 Oct;50(5):2105-2111. doi: 10.1007/s00068-024-02565-0. Epub 2024 Jun 14.

  PMID: 38874624 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

• 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

• 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

• Al Tannir AH, Tentis M, Maring M, Patin B, Biesboer EA, Golestani S, Pokrzywa CJ, Peschman J, Murphy PB, Morris RS, Carver TW, de Moya MA. Can Concurrent Traumatic Hemopneumothorax be Safely Observed? J Surg Res. 2024 Dec;304:400-407. doi: 10.1016/j.jss.2024.09.085. Epub 2024 Oct 24.

  PMID: 39455348 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

Hemothorax; Hemopneumothorax

Interventions

Suction

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative

Central Study Contacts

Kelsey Evans, MD

CONTACT

615-322-5000; kelsey.evans@vumc.org

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: single center, non-blinded, clustered randomized controlled trial with two interventions.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 27, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)