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

NCT03034421 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-07-07

No results posted yet for this study

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.

Conditions

  • Pneumothorax

Interventions

BEHAVIORAL

Bed rest

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

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Daniela Gompelmann, MD · Thoraxklinik at University of Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-08-30
Completion
2018-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03034421 on ClinicalTrials.gov