Status:

RECRUITING

Diaphragm Paralysis: Surgery or Mechanical Ventialion

Lead Sponsor:

University Medical Center Groningen

Collaborating Sponsors:

ZonMw: The Netherlands Organisation for Health Research and Development

Conditions:

Diaphragm Paralysis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Summary Rationale: The diaphragm is a dome-shaped muscle which separates the thoracic cavity from the abdomen. In patients with diaphragm paralysis the treatment (surgery versus non-invasive ventilati...

Detailed Description

INTRODUCTION AND RATIONALE The diaphragm is a dome-shaped muscle which separates the thoracic cavity from the abdomen. It is the most important muscle of respiration innervated by the phrenic nerves....

Eligibility Criteria

Inclusion Criteria:

  • >18 years
  • diagnosed with a unilateral diaphragm paralysis based on isolated phrenic nerve injury.

Unilateral diaphragm paralysis is defined as follows: complaints of dyspnea and / or orthopnea combined with a drop in VC of more than 15% when change from upright to supine position and a positive sniff test during fluoroscopy or ultrasonography. A positive sniff test means that the diaphragm stands still or even moves in cranial direction (paradoxical movement ) during the sniff inspiratory maneuver.

  • Ability to provide written consent
  • Time between diagnosis and treatment should be at least 1 year

Exclusion Criteria:

  • Patients diagnosed with a bilateral diaphragm paralysis.
  • A diaphragm paralysis in combination with a more systemic neurological or neuromuscular disorder like for example Amyotrophic Lateral Sclerosis ,
  • Hypercapnia during daytime (PaCO2 > 6.0 kPa)
  • Radiotherapy of the thorax
  • Contra indication for diaphragm surgery.

Key Trial Info

Start Date :

June 28 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2025

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT05027035

Start Date

June 28 2024

End Date

June 1 2025

Last Update

December 11 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University Medical Center Groningen

Groningen, Netherlands, 9700 RB

Diaphragm Paralysis: Surgery or Mechanical Ventialion | DecenTrialz