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

Pneumothorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03034421
• Other study ID #: Protocol G1.1 - 17.04.2016
• Status: Terminated
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: July 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: September 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Emphysema
• Pneumothorax

Intervention

Behavioral:
• Bed rest
Patients will undergo bed rest for 48 hours following endoscopic valve implantation.

Locations

Country	Name	City	State
Germany	Thoraxklinik Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days following valve implantation
Secondary	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.	30 and 90 days following valve implantation
Secondary	Excercise capacity before and after valve therapy	6-minute-walk test (m) will be assessed 30 and 90 days following valve implantation.	30 and 90 days following valve implantation
Secondary	Dyspnoe score before and after valve therapy	Dyspnoe score (mMRC) will be assessed 30 and 90 days following valve implantation.	30 and 90 days following valve implantation