Discharged with Indwelling Chest Tube and Valve

Not Applicable

Suspended

• Conditions: Prolonged Air Leak
• Interventions: Other: Standard of Care; Other: Oral Antibiotics-Close Monitoring

• Registration Number: NCT03943511
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Study Start: 2019-10-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 560

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Standard of Care	Standard of Care
Group 1	Oral Antibiotics-Close Monitoring	Oral Antibiotics

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States