Discharged With Indwelling Chest Tube and Valve

Prolonged Air Leak Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03943511
• Other study ID #: 17-007774
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 560
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prolonged Air Leak

Intervention

Other:
• Oral 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.
• Standard of Care
No calls from the care team but waiting for the subject to contact the care team when the air leak has stopped.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials