Suction vs Underwater Seal for HemoPneumoThoraX Trial (SUS-HPTX)

May 29, 2026 updated by: Kelsey Evans, Vanderbilt University Medical Center

SUS-HPTX Trial: Suction vs Underwater Seal for HemoPneumoThoraX Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Traumatic pneumothorax occurs in up to 20% of major trauma patients and is frequently accompanied by hemothorax, with concomitant hemothorax reported in up to 70% of cases. These injuries are typically managed with placement of a chest tube to evacuate air and blood from the pleural space, facilitate lung re-expansion, and prevent respiratory or hemodynamic compromise. Following placement, chest tubes are commonly managed using either continuous negative-pressure suction (typically -20 cm H₂O) or water seal alone. Although both methods are widely accepted as standard-of-care, substantial variation exists in clinical practice regarding the initial suction status of chest tubes, with decisions often driven by provider preference or institutional norms rather than high-quality evidence.

Suction theoretically promotes lung re-expansion by generating negative intrathoracic pressure; however, studies in postoperative thoracic surgery patients suggest that suction may prolong or exacerbate air leaks, potentially increasing chest tube duration. Prior trauma-focused studies evaluating suction versus water seal have produced conflicting results with respect to chest tube duration, pleural space complications, and hospital length of stay. The predecessor SEAL IT trial conducted at the study institution demonstrated that initial water seal management reduced chest tube duration in patients with traumatic pneumothorax without increasing complications; however, that study excluded patients with larger hemothoraces, leaving uncertainty regarding optimal initial management in patients with hemothorax or hemopneumothorax.

Given the limited and conflicting data in trauma patients with hemothorax or hemopneumothorax, further investigation is warranted to determine whether initial water seal management is noninferior or superior to suction in this population. This trial is designed to address this knowledge gap by evaluating whether initial placement of chest tubes to water seal decreases chest tube duration without increasing complications when compared with initial suction.

This trial is a single-center, non-blinded, clustered randomized controlled trial conducted at Vanderbilt University Medical Center. Adult trauma patients admitted to the trauma service who require placement of a chest tube (percutaneous or open) for treatment of traumatic hemothorax or hemopneumothorax are eligible for enrollment. Patients are excluded if they are younger than 18 years of age, are pregnant, are prisoners, or have had a chest tube placed prior to computed tomography imaging. Randomization is performed using a cluster-by-month design. During odd calendar months (January, March, May, July, September, and November), all enrolled patients will have their chest tubes placed to water seal initially. During even calendar months (February, April, June, August, October, and December), all enrolled patients will have their chest tubes placed to -20 cm H₂O suction initially. This design minimizes treatment contamination and facilitates enrollment in an emergent setting.

For patients randomized to the water seal group, the chest tube will be briefly placed to suction for one minute immediately following placement to evacuate residual air and blood, after which it will be transitioned to water seal. For patients randomized to the suction group, the chest tube will remain on -20 cm H₂O suction after placement. Aside from the initial suction status, all subsequent chest tube management decisions-including changes in suction status, imaging frequency, duration of tube placement, and criteria for removal-will be determined at the discretion of the treating clinical team, consistent with usual care. Any changes in suction status and the reasons for those changes will be documented.

The primary outcome of the trial is the duration of the initial chest tube in place, measured in hours from placement to removal. Secondary outcomes include chest tube-related complications such as transitions from water seal to suction, pneumothorax or hemothorax re-accumulation, need for additional or replacement chest tubes, need for intrapleural tissue plasminogen activator, development of empyema or pneumonia, hypoxic events, need for video-assisted thoracoscopic surgery, unplanned intensive care unit (ICU) admission, acute respiratory failure requiring intubation, length of hospital stay, 30-day mortality, and 30-day readmission. Exploratory outcomes include measures of residual pleural space pathology, air leak persistence, imaging utilization, chest tube-related costs, and ICU-related outcomes.

Data for the study will be collected retrospectively from the electronic health record and stored in a secure REDCap database using coded identifiers to protect participant confidentiality. Patients will be followed for up to 30 days after hospital discharge for assessment of readmissions and subsequent thoracic interventions. The trial is conducted under a waiver of informed consent due to the minimal incremental risk associated with participation, the emergent nature of chest tube placement in trauma patients, and the impracticability of obtaining consent in many cases due to acute illness, altered mental status, or absence of legally authorized representatives. Both initial chest tube management strategies evaluated in this study are considered standard-of-care, and clinicians retain full authority to modify chest tube management at any time to ensure patient safety.

A Data Safety and Monitoring Board will oversee trial conduct and safety. Adverse events will be monitored from the time of enrollment through 30 days following discharge and reported in accordance with institutional and regulatory requirements. Through systematic comparison of initial water seal versus suction management in traumatic hemothorax and hemopneumothorax, the SUS-HPTX trial aims to provide high-quality evidence to inform chest tube management strategies and potentially reduce chest tube duration, complications, and hospital resource utilization in trauma patients.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Less than 18 years old, pregnant, prisoner, chest tube placed prior to CT scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Even months
Other: Suction
Initial chest tube placed to suction
Experimental: Odd months
Other: Water Seal
Initial chest tube placed to water seal

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 251524

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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