Discharged With Indwelling Chest Tube and Valve

Mayo Clinic25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Prolonged Air Leak

Interventions

Oral Antibiotics-Close MonitoringOTHER

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.

Standard of CareOTHER

No calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Rush University Medical Center

Chicago, Illinois, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 30 days post discharge

Secondary Outcomes

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.

Time frame: 30 days post discharge

Data from ClinicalTrials.gov

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