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

Heidelberg University38 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pneumothorax

Interventions

Bed restBEHAVIORAL

Patients will undergo bed rest for 48 hours following endoscopic valve implantation.

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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)

Locations (1)

Thoraxklinik Heidelberg

Heidelberg, Germany

Outcomes

Primary Outcomes

Advent of pneumothorax within 90 days following valve implantation

Incidence of pneumothorax that is confirmed by radiological procedures within 90 days after implantation of valves.

Time frame: 90 days following valve implantation

Secondary Outcomes

Lung function before and after valve therapy

Lung function parameters (VC \[L\], FEV1 \[L\], RV \[L\], TLC \[L\] will be assessed 30 and 90 days following valve implantation.

Time frame: 30 and 90 days following valve implantation

Excercise capacity before and after valve therapy

6-minute-walk test (m) will be assessed 30 and 90 days following valve implantation.

Time frame: 30 and 90 days following valve implantation

Dyspnoe score before and after valve therapy

Dyspnoe score (mMRC) will be assessed 30 and 90 days following valve implantation.

Time frame: 30 and 90 days following valve implantation

Data from ClinicalTrials.gov

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