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Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency (TETRADIA-UNI)

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: February 2, 2010
Last updated: June 17, 2013
Last verified: June 2013
This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in tetraplegic patients with ventilatory insufficiency.

Condition Intervention Phase
Tetraplegia Procedure: reinnervation Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phrenic Reinnervation in Central Ventilatory Paralysis Due to Medullary Trauma With Phrenic Motoneuron Destruction

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • recovery of spontaneous ventilation [ Time Frame: 2 years ]

Enrollment: 5
Study Start Date: March 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients
Procedure: reinnervation
anastomosis between right inferior laryngeal nerve and right phrenic nerve
Other Name: laryngeal reinnervation


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • tetraplegia c3-c4
  • respiratory insufficiency

Exclusion Criteria:

  • PM
  Contacts and Locations
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Please refer to this study by its identifier: NCT01350297

Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Study Chair: VERIN Eric, MD University Hospital, Rouen
  More Information

Responsible Party: University Hospital, Rouen Identifier: NCT01350297     History of Changes
Other Study ID Numbers: 2009/023/HP
Study First Received: February 2, 2010
Last Updated: June 17, 2013

Keywords provided by University Hospital, Rouen:
phrenic nerve

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on September 25, 2017