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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pneumothorax

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Modified medical care

Patients will undergo 48-hours bed rest after endoscopic valve implantation.

Group Type ACTIVE_COMPARATOR

Bed rest

Intervention Type BEHAVIORAL

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

Standard medical care

Patients will be treated with standard medical care without restriction to bed rest after endoscopic valve implantation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bed rest

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No