Diaphragm Plication in Adults With Phrenic Nerve Paralysis

August 5, 2013 updated by: Marc Decramer, KU Leuven

Diaphragm Plication in Adults With Phrenic Nerve Paralysis: a Randomised Controlled Study

The purpose of the study is to investigate the impact of unilateral or bilateral diaphragm plication in a prospective randomised controlled way on symptoms, pulmonary function including gas exchange, respiratory muscle strength, exercise capacity and breathing during sleep in patients with proven uni- or bilateral phrenic nerve paralysis present for at least 1 year without any evidence of spontaneous recovery.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Leuven, Belgium, 3000
        • Recruiting
        • University Hospital Gasthuisberg Divisionof Pulmonology
        • Contact:
        • Principal Investigator:
          • Buyse MA Buyse, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Uni- or bilateral diaphragmatic paralysis due to phrenic nerve paralysis present for at least 1 year
  • With reduced VC, at least in supine position and no significant change in VC for at least 6 months
  • At the time of randomisation symptomatic patient, defined by one of the following symptoms: not able to sleep in supine position or exertional dyspnoea

Exclusion Criteria:

  • No informed consent obtained
  • Other disease that may interfere with the evaluation of pulmonary function or the exercise capacity: COPD, parenchymal lung disease on the thoracic X-ray, documented ischemic heart disease or left heart failure, active rheumatological disease, severe orthopaedic problems,....
  • Abnormal neuromuscular clinical investigation (apart from diaphragmatic dysfunction) and/or abnormal electromyography of the limbs compatible with generalized neuromuscular disease
  • Known diseases resulting in abnormal blood coagulation
  • Proven oncological origine of the phrenic nerve paralysis
  • Age below 18 yrs old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: A
At time of inclusion randomised in the "no intervention" arm (the subjects will be re-evaluated 6 months later and will get intervention at that time (cross-over protocol)
thoracotomy
ACTIVE_COMPARATOR: B
At time of inclusion the subject get the intervention
thoracotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: 6 months after inclusion
Functional outcome measured by dyspnea score
6 months after inclusion
Dyspnea
Time Frame: 12 months after inclusion
Functional outcome measured by dyspnea score
12 months after inclusion
Exercise capacity
Time Frame: 6 months after inclusion
Functional outcome measured by exercise testing
6 months after inclusion
Exercise capacity
Time Frame: 12 months after inclusion
Functional outcome measured by exercise testing
12 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function
Time Frame: 6 months after inclusion
Measurement of pulmonary function
6 months after inclusion
Pulmonary function
Time Frame: 12 months after inclusion
Measurement of pulmonary function
12 months after inclusion
Sleep
Time Frame: 6 months after inclusion
Polysomnography evaluation
6 months after inclusion
Sleep
Time Frame: 12 months after inclusion
Polysomnography evaluation
12 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ANTICIPATED)

April 1, 2014

Study Completion (ANTICIPATED)

April 1, 2014

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (ESTIMATE)

June 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 5, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • B32220083458 (no sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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