Discharged With Indwelling Chest Tube and Valve

Mayo Clinic

Status: Terminated

Conditions: Prolonged Air Leak

Treatments: Other: Standard of Care; Other: Oral Antibiotics-Close Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03943511

17-007774

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Oral Antibiotics

Treatment:

Other: Oral Antibiotics-Close Monitoring

Group 2

Active Comparator group

Description:

Standard of Care

Treatment:

Other: Standard of Care