NCT03034421

Prevention of Pneumothorax Following Endoscopic Valve Therapy in Patients With Severe Emphysema

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

Endoscopic valve therapy is an effective therapy for patients with severe emphysema and low interlobar collateral ventilation. Although, valve therapy is a minimal-invasive treatment approach, it is associated with complications the most common of which is pneumothorax with a rate of 18-25%. Modifying post-operative medical care including bed rest for 48 hours after valve implantation may reduce the risk of post-interventional pneumothorax.

Detailed description

Patient enrolment and data acquisition is to be carried out on a prospective basis. It is planned to enrol a total of 130 patients with advanced emphysema and low collateral ventilation. Patients will be randomly assigned in a 1:1 ratio to receive modified medical care including a 48 bed rest or standard medical care following valve implantation. All patients will undergo treatment at one study centre in Heidelberg.

Conditions

• Pneumothorax

Interventions

Type	Name	Description
BEHAVIORAL	Bed rest	Patients will undergo bed rest for 48 hours following endoscopic valve implantation.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-08-30
• Completion: 2018-09-30
• First posted: 2017-01-27
• Last updated: 2022-07-07

Locations

1 site across 1 country: Germany