Discharged With Indwelling Chest Tube and Valve

Study Overview
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Brief Summary
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This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.

Detailed Description
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This study is a multicenter, randomized trial for the treatment of subjects discharging from the hospital with a chest tube and valve in place. Subjects will be screened prior to discharging from the hospital and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained the subject will be randomized to receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve or standard of care, defined as no calls from the care team but waiting for the subject to contact the care team when the air leak has stopped. The subject will be followed until they have their chest tube removed.

Official Title
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A Randomized Study Evaluating Patients Discharged With Indwelling Chest Tube and Valve

Conditions
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Prolonged Air Leak

Intervention / Treatment
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* Other: Oral Antibiotics-Close Monitoring
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Male and Female Consultation with a thoracic surgeon Discharge from the hospital with a chest tube and valve in place Subject is able to understand the study procedures and provide informed consent. Exclusion Criteria: Pregnancy Allergy to Keflex and Clindamycin Special consideration should be taken in enrolling subjects with preexisting conditions that can be exacerbated by antibiotic use but are allowed at the discretion of the treating physician.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Oral Antibiotics | Other: Oral Antibiotics-Close Monitoring<br>* To receive oral antibiotics and close monitoring, defined as twice weekly telephone calls by a member of the care team, of their chest tube and valve.<br>|
| Active Comparator: Group 2<br>Standard of Care | Other: Standard of Care<br>* No calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in empyema in patient's discharging with an indwelling chest tube and valve. | The proportion of patients having 30-day empyema in the two treatment arms will be estimated and reported. | 30 days post discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of 30-day readmission in patient's discharging with an indwelling chest tube and valve. | The proportion of patients having a 30-day readmission in the two treatment arms will be estimated and reported. | 30 days post discharge |