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Water Seal vs. Suction for Collapsed Lung (SEAL IT Trial)
N/A
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Admitted to the trauma surgery service
Pneumothorax requiring a chest tube
Must not have
Less than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if starting chest tubes with water seal or suction first leads to shorter chest tube use in patients with traumatic pneumothoraces. Patients will have their chest tubes set to either water
Who is the study for?
This trial is for adults with a collapsed lung due to trauma who need a chest tube and are under the care of the trauma surgery service. It's not for those under 18, pregnant women, prisoners, or patients with over 300cc of blood in the chest or a chest tube placed before CT scans.
What is being tested?
The SUC IT trial is testing whether starting with a water seal rather than suction on chest tubes can reduce how long patients need them after traumatic pneumothorax without increasing complications. The method used alternates monthly.
What are the potential side effects?
Potential side effects may include discomfort at the tube site, infection risk, breathing difficulties if complications arise from treatment methods (water seal vs. suction), but specific side effects will depend on individual patient responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am under the care of the trauma surgery team.
Select...
I have had a collapsed lung treated with a chest tube.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Chest tube duration
Secondary study objectives
30-day mortality
30-day readmission
Acute respiratory failure requiring intubation
+15 moreOther study objectives
Chest tube related costs
Discharge disposition
Length of ICU stay
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Initial Water SealExperimental Treatment1 Intervention
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.
Group II: Initial SuctionExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
906 Previous Clinical Trials
934,419 Total Patients Enrolled