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Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial

Suction Versus Water Seal for Initial Treatment of Traumatic Pneumothorax Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06688734
Acronym
SEAL IT
Enrollment
72
Registered
2024-11-14
Start date
2024-10-01
Completion date
2025-06-20
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumothorax, Trauma

Keywords

traumatic, trauma, pneumothorax, chest tube, duration

Brief 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. 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.

Interventions

PROCEDUREInital water seal

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.

PROCEDUREInitial suction

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.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Chest tube durationThrough study completion, an average of 1 yearDuration of the initial chest tube, measured in hours

Secondary

MeasureTime frameDescription
Hypoxic eventsThrough study completion, an average of 1 yearYes/no Yes if \<90% O2 saturation is recorded in chart
Chest tube site, skin and soft tissue infectionThrough study completion, an average of 1 yearYes/no Yes if skin and soft tissue infection treated with incision and drainage, or antibiotics
Video-assisted thoracoscopic surgeryThrough study completion, an average of 1 yearYes/no Yes if receives video-assisted thoracoscopic surgery on the affected side during initial admission
Acute respiratory failure requiring intubationThrough study completion, an average of 1 yearYes/no Yes if intubated for hypoxia or hypercapnea during hospital stay
Unplanned ICU admissionThrough study completion, an average of 1 yearYes/no Yes if admitted to ICU unexpectedly, for clinical deterioration
30-day mortalityThrough study completion, an average of 1 yearYes/no Yes if died within 30 days of initial presentation
Length of hospital stayThrough study completion, an average of 1 yearInteger, measured in days, length of initial hospital stay
30-day readmissionThrough study completion, an average of 1 yearYes/no Yes if readmitted within 30 days of discharge
Thoracic intervention during readmissionThrough study completion, an average of 1 yearYes/no Yes if readmitted and receives chest tube, video-assisted thoracoscopic surgery, or thoracotomy on the affected side
Change from water seal to suctionThrough study completion, an average of 1 yearYes/No
Additional chest tube placement on affected sideThrough study completion, an average of 1 yearYes/no
Pneumothorax reaccumulation with chest tube to water sealThrough study completion, an average of 1 yearYes/no Yes if growth of pneumothorax on chest x-ray with tube to water seal
Replacement of chest tubeThrough study completion, an average of 1 yearYes/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 removalThrough study completion, an average of 1 yearYes/no Yes if pneumothorax grows on chest x-ray after chest tube removal
EmpyemaThrough study completion, an average of 1 yearYes/no Yes if clinically diagnosed by provider based off of imaging, operative findings, clinical picture, culture results, or operative findings
PneumoniaThrough study completion, an average of 1 yearYes/no Yes if clinically diagnosed and treated for pneumonia
Retained hemothoraxThrough study completion, an average of 1 yearYes/no Yes if \>300cc hemothorax seen on CT scan after chest tube placement
TPA administrationThrough study completion, an average of 1 yearYes/no Yes if any TPA administered to the affected side of the chest

Other

MeasureTime frameDescription
Number of chest x-raysThrough study completion, an average of 1 yearInteger, number of chest x-rays after initial trauma evaluation
Number of CT scans of chest after initial imagingThrough study completion, an average of 1 yearInteger value Number of CT scans of chest after initial trauma evaluation during hospital stay
Chest tube related costsThrough study completion, an average of 1 yearInteger, 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 ventilationThrough study completion, an average of 1 yearYes/no Yes if was on mechanical ventilation at any point during hospitalization
Length of ICU stayThrough study completion, an average of 1 yearTotal times spent in the ICU, measured in days
Discharge dispositionThrough study completion, an average of 1 yearCategorical Home, inpatient rehab, skilled nursing facility, long term acute care hospital, or died
Presence of air leak each dayThrough study completion, an average of 1 yearYes/no Recorded each day there is a chest tube present
Size of residual pneumothorax on first chest x-rayThrough study completion, an average of 1 yearMeasured in cm, largest distance from lung edges to chest wall

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026