Prolonged Air Leak
Conditions
Brief summary
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
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.
Interventions
OTHEROral Antibiotics-Close Monitoring
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.
OTHERStandard of Care
No calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in empyema in patient's discharging with an indwelling chest tube and valve. | 30 days post discharge | The proportion of patients having 30-day empyema in the two treatment arms will be estimated and reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of 30-day readmission in patient's discharging with an indwelling chest tube and valve. | 30 days post discharge | The proportion of patients having a 30-day readmission in the two treatment arms will be estimated and reported. |
Countries
United States
Outcome results
None listed