Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Completed
NCT Number: NCT06688734
Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial
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.
Completed
Looking for future studies?
Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Inital water seal
ProcedureAfter 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
ProcedureAfter 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.
Primary outcomes
-
Chest tube duration
Time frame: Through study completion, an average of 1 year
Duration of the initial chest tube, measured in hours
Secondary outcomes
-
Change from water seal to suction
Time frame: Through study completion, an average of 1 year
Yes/No
-
Additional chest tube placement on affected side
Time frame: Through study completion, an average of 1 year
Yes/no
-
Pneumothorax reaccumulation with chest tube to water seal
Time frame: Through study completion, an average of 1 year
Yes/no Yes if growth of pneumothorax on chest x-ray with tube to water seal
-
Replacement of chest tube
Time frame: Through study completion, an average of 1 year
Yes/no Yes if chest tube removed and then a new one is place on the same side at a later time
-
Pneumothorax reaccumulation after chest tube removal
Time frame: Through study completion, an average of 1 year
Yes/no Yes if pneumothorax grows on chest x-ray after chest tube removal
-
Hypoxic events
Time frame: Through study completion, an average of 1 year
Yes/no Yes if <90% O2 saturation is recorded in chart
-
Empyema
Time frame: Through study completion, an average of 1 year
Yes/no Yes if clinically diagnosed by provider based off of imaging, operative findings, clinical picture, culture results, or operative findings
-
Pneumonia
Time frame: Through study completion, an average of 1 year
Yes/no Yes if clinically diagnosed and treated for pneumonia
-
Retained hemothorax
Time frame: Through study completion, an average of 1 year
Yes/no Yes if >300cc hemothorax seen on CT scan after chest tube placement
-
TPA administration
Time frame: Through study completion, an average of 1 year
Yes/no Yes if any TPA administered to the affected side of the chest
-
Chest tube site, skin and soft tissue infection
Time frame: Through study completion, an average of 1 year
Yes/no Yes if skin and soft tissue infection treated with incision and drainage, or antibiotics
-
Video-assisted thoracoscopic surgery
Time frame: Through study completion, an average of 1 year
Yes/no Yes if receives video-assisted thoracoscopic surgery on the affected side during initial admission
-
Acute respiratory failure requiring intubation
Time frame: Through study completion, an average of 1 year
Yes/no Yes if intubated for hypoxia or hypercapnea during hospital stay
-
Unplanned ICU admission
Time frame: Through study completion, an average of 1 year
Yes/no Yes if admitted to ICU unexpectedly, for clinical deterioration
-
30-day mortality
Time frame: Through study completion, an average of 1 year
Yes/no Yes if died within 30 days of initial presentation
-
Length of hospital stay
Time frame: Through study completion, an average of 1 year
Integer, measured in days, length of initial hospital stay
-
30-day readmission
Time frame: Through study completion, an average of 1 year
Yes/no Yes if readmitted within 30 days of discharge
-
Thoracic intervention during readmission
Time frame: Through study completion, an average of 1 year
Yes/no Yes if readmitted and receives chest tube, video-assisted thoracoscopic surgery, or thoracotomy on the affected side
Other outcomes
-
Size of residual pneumothorax on first chest x-ray
Time frame: Through study completion, an average of 1 year
Measured in cm, largest distance from lung edges to chest wall
-
Presence of air leak each day
Time frame: Through study completion, an average of 1 year
Yes/no Recorded each day there is a chest tube present
-
Number of chest x-rays
Time frame: Through study completion, an average of 1 year
Integer, number of chest x-rays after initial trauma evaluation
-
Number of CT scans of chest after initial imaging
Time frame: Through study completion, an average of 1 year
Integer value Number of CT scans of chest after initial trauma evaluation during hospital stay
-
Chest tube related costs
Time frame: Through study completion, an average of 1 year
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
-
Mechanical ventilation
Time frame: Through study completion, an average of 1 year
Yes/no Yes if was on mechanical ventilation at any point during hospitalization
-
Length of ICU stay
Time frame: Through study completion, an average of 1 year
Total times spent in the ICU, measured in days
-
Discharge disposition
Time frame: Through study completion, an average of 1 year
Categorical Home, inpatient rehab, skilled nursing facility, long term acute care hospital, or died
Sponsors and collaborators
Lead sponsor
Vanderbilt University Medical Center
Other
Registry information
Acronym: SEAL IT
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Nov 14, 2024
- Registry last updated
- Aug 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
Drainage Amount for Removal of Thoracostomy Tube
NCT00575198
Pleural Diseases, Pleural Effusion
Sacramento, California, United States
View Trial Details
Completed
Hypobaria and Traumatic Pneumothorax
NCT01670942
Pleural Diseases, Pneumothorax
Murray, Utah, United States
View Trial Details
Completed
Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice
NCT05963945
Atelectasis, Cardiomegaly
Havířov, Czechia
View Trial Details
Completed
Low Tidal MEChanical Ventilation Against NO Ventilation During Cardiopulmonary Bypass Heart Surgery
NCT03098524
Atelectasis, Bleeding
Neuilly-sur-Seine, Île-de-France Region, France
View Trial Details