Pneumothorax
Conditions
Brief 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.
Interventions
BEHAVIORALBed rest
Patients will undergo bed rest for 48 hours following endoscopic valve implantation.
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Advent of pneumothorax within 90 days following valve implantation | 90 days following valve implantation | Incidence of pneumothorax that is confirmed by radiological procedures within 90 days after implantation of valves. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung function before and after valve therapy | 30 and 90 days following valve implantation | Lung function parameters (VC \[L\], FEV1 \[L\], RV \[L\], TLC \[L\] will be assessed 30 and 90 days following valve implantation. |
| Excercise capacity before and after valve therapy | 30 and 90 days following valve implantation | 6-minute-walk test (m) will be assessed 30 and 90 days following valve implantation. |
| Dyspnoe score before and after valve therapy | 30 and 90 days following valve implantation | Dyspnoe score (mMRC) will be assessed 30 and 90 days following valve implantation. |
Countries
Germany
Outcome results
None listed