PneumothoraxSEAL ITNCT06688734
Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial
A study testing Inital water seal and Initial suction in people with Pneumothorax and Trauma, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax, Trauma
- What is being tested?
- Inital water seal and Initial suction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted to the trauma surgery service
- pneumothorax requiring a chest tube
Who cannot join
- less than 18 years olf
- pregnant
- prisoner
- greater than 300cc of hemothorax on CT
- chest tube placed prior to CT scan
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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
- Being tested
- Inital water seal, Initial suction
- Keywords
- traumatic, trauma, pneumothorax, chest tube, duration
- Medical subject headings
- Pneumothorax, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inital water sealProcedure or surgery
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 suctionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Initial suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest tube duration
Duration of the initial chest tube, measured in hours
Measured: Through study completion, an average of 1 year
Secondary outcomes (18)
Change from water seal to suction
Yes/No
Measured: Through study completion, an average of 1 year
Additional chest tube placement on affected side
Yes/no
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Hypoxic events
Yes/no Yes if <90% O2 saturation is recorded in chart
Measured: 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
Measured: Through study completion, an average of 1 year
Pneumonia
Yes/no Yes if clinically diagnosed and treated for pneumonia
Measured: Through study completion, an average of 1 year
Retained hemothorax
Yes/no Yes if >300cc hemothorax seen on CT scan after chest tube placement
Measured: Through study completion, an average of 1 year
TPA administration
Yes/no Yes if any TPA administered to the affected side of the chest
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1 year
Unplanned ICU admission
Yes/no Yes if admitted to ICU unexpectedly, for clinical deterioration
Measured: Through study completion, an average of 1 year
30-day mortality
Yes/no Yes if died within 30 days of initial presentation
Measured: Through study completion, an average of 1 year
Length of hospital stay
Integer, measured in days, length of initial hospital stay
Measured: Through study completion, an average of 1 year
30-day readmission
Yes/no Yes if readmitted within 30 days of discharge
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Oct 2024
- Primary completion31 May 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Yeates, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688734
- Sponsor's protocol ID
- 241132
- Acronym
- SEAL IT
- Status last verified
- Aug 2025
- First submitted
- 10 Nov 2024
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29546613Muslim 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.
PubMed 19999219Majumdar 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.
PubMed 25058250Marshall 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.
PubMed 11888968Cerfolio 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.
PubMed 11383809Anderson 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.
PubMed 35080596Di 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.
PubMed 11586158Yeates EO, Dennis BM, Xiao D, Vimalathas P, Patel MB, Medvecz A, Maiga A, Gondek SP, Peetz AB. Suction vs Water Seal for Initial Treatment of Traumatic Pneumothorax Trial (SEAL IT): A Pragmatic Cluster-Randomized Study. J Am Coll Surg. 2026 Sep 1. doi: 10.1097/XCS.0000000000002190. Online ahead of print.
PubMed 42678774
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial
- ClinicalTrials.gov ID
- NCT06688734
- Acronym / sponsor ID
- SEAL IT / 241132
- Conditions
- Pneumothorax, Trauma
- Keywords
- traumatic, trauma, pneumothorax, chest tube, duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Initial Water Seal | Experimental | Procedure: Inital water sealAfter 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 Suction | Experimental | Procedure: Initial suctionAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- admitted to the trauma surgery service
- pneumothorax requiring a chest tube
Key exclusion criteria (5 listed)
- less than 18 years olf
- pregnant
- prisoner
- greater than 300cc of hemothorax on CT
- chest tube placed prior to CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inital water sealAfter 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 or surgery | Initial Water Seal |
| Initial suctionAfter 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 or surgery | Initial Suction |
Primary outcome
Chest tube duration
Time frame: Through study completion, an average of 1 year
Duration of the initial chest tube, measured in hours
18 secondary outcomes
Change from water seal to suction
Time frame: Through study completion, an average of 1 year
Additional chest tube placement on affected side
Time frame: Through study completion, an average of 1 year
Pneumothorax reaccumulation with chest tube to water seal
Time frame: Through study completion, an average of 1 year
Replacement of chest tube
Time frame: Through study completion, an average of 1 year
Pneumothorax reaccumulation after chest tube removal
Time frame: Through study completion, an average of 1 year
Hypoxic events
Time frame: Through study completion, an average of 1 year
Empyema
Time frame: Through study completion, an average of 1 year
Pneumonia
Time frame: Through study completion, an average of 1 year
Retained hemothorax
Time frame: Through study completion, an average of 1 year
TPA administration
Time frame: Through study completion, an average of 1 year
Chest tube site, skin and soft tissue infection
Time frame: Through study completion, an average of 1 year
Video-assisted thoracoscopic surgery
Time frame: Through study completion, an average of 1 year
Acute respiratory failure requiring intubation
Time frame: Through study completion, an average of 1 year
Unplanned ICU admission
Time frame: Through study completion, an average of 1 year
30-day mortality
Time frame: Through study completion, an average of 1 year
Length of hospital stay
Time frame: Through study completion, an average of 1 year
30-day readmission
Time frame: Through study completion, an average of 1 year
Thoracic intervention during readmission
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Background: PubMed 29546613Feenstra 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.
- Background: PubMed 19999219Muslim 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.
- BackgroundMajumdar 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: PubMed 25058250Morales 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.
- Background: PubMed 11888968Marshall 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.
- Background: PubMed 11383809Cerfolio 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.
- Background: PubMed 35080596Anderson 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.
- Background: PubMed 11586158Di 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.
- Derived from this study: PubMed 42678774Yeates EO, Dennis BM, Xiao D, Vimalathas P, Patel MB, Medvecz A, Maiga A, Gondek SP, Peetz AB. Suction vs Water Seal for Initial Treatment of Traumatic Pneumothorax Trial (SEAL IT): A Pragmatic Cluster-Randomized Study. J Am Coll Surg. 2026 Sep 1. doi: 10.1097/XCS.0000000000002190. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Pneumothorax
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
Not yet recruitingPhase 2/3
Stop Air Leak by Talc or Autologous Blood Patch Therapy
Pneumothorax Spontaneous Secondary
Active, not recruiting
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
Pneumothorax Spontaneous Primary
Not yet recruitingObservational study
The Impact of Artificial Intelligence-Assisted X-ray Interpretation on Radiologists' Diagnostic Performance
Pneumothorax, Intestinal Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inital water seal and Initial suction in people with Pneumothorax and Trauma, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest tube duration (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06688734, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.