Suction vs Underwater Seal for HemoPneumoThoraX Trial

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07551791
Status
Recruiting

Conditions

  • Hemopneumothorax; Traumatic
  • Hemothorax; Traumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Suction — OTHER
    Initial chest tube placed to suction
  • Water Seal — OTHER
    Initial chest tube placed to water seal

Study Details

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

Key Dates

Start date
Apr 14, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Even months
  • Experimental: Odd months

Primary Outcome Measure

Chest tube duration [ Time Frame: hours from placement of chest tube to removal of chest tube, on average 3 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Kelsey Evans, MD
615-322-2063
Allan Peetz, MD

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