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

Heidelberg University

Status

Terminated

Conditions

Pneumothorax

Treatments

Behavioral: Bed rest

Study type

Interventional

Funder types

Other

Identifiers

NCT03034421

Protocol G1.1 - 17.04.2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

FEV1 < 50%, RV>150%, TLC>100%
emphysema confirmed by computed tomography
pO2 >60 mmHg (with supplemental oxygen), pCO2 < 55 mmHg (room condition)
no significant collateral ventilation (assessed by fissure analysis and/or catheter-based measurement)
no COPD exacerbation within the past 8 weeks
daily use of < 20 mg Prednisolon
non-smoking for a minimum of 4 months prior to consent
Patient has provided written informed consent

Exclusion criteria

BMI < 18 kg/m²
clinically relevant bronchiectasis
failed cardiac clearance: defined as myocardial infarction within last 6 weeks, decompensation of heart failure
Prior lung resection (e.g. lobectomy)