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Diaphragmatic Height Index: the New Diagnostic Test for Phrenic Nerve Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01450917
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : October 12, 2011
Information provided by (Responsible Party):
Mahidol University

Brief Summary:

Diaphragmatic contraction is controlled by phrenic nerve which consists of anterior rami of 3rd- 5th cervical nerve roots. Usually, It can't be evaluated from history taking and physical examination. Thus the diaphragmatic elevation on chest radiograph is assumed to identify the phrenic nerve dysfunction. Normally, the right diaphragm is higher than the left side about 1.5 ± 0.9 centimeters or 0.5 ± 0.3 time of vertebral height. Although there are several methods to determine the diaphragmatic elevation from previous studies, the accuracy, reliability, intra and inter-observer variation are problem.

Neurotization is the effective procedure to restore upper extremity function in root avulsion type. Phrenic nerve is one of the common donor nerves which used for this procedure. But sometimes, concomitant injury of this nerve can occur. Therefore, the investigators established "Diaphragmatic height index (DHI)" from chest radiograph to use as the diagnostic test for phrenic nerve dysfunction.

Condition or disease
Respiratory Paralysis

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Study Type : Observational
Actual Enrollment : 245 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Diaphragmatic Height Index: the New Diagnostic Test for Phrenic Nerve Dysfunction
Study Start Date : September 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Group A
Brachial plexus injured patients with phrenic nerve dysfunction
Group B
Brachial plexus injured patients without phrenic nerve dysfunction
Group C
Non brachial plexus injured patients

Primary Outcome Measures :
  1. The cut-off point of DHI for diagnosis of phrenic nerve dysfunction [ Time Frame: upto 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
220 brachial plexus injured patients who underwent the neurotization and 80 non-brachial plexus injury patients who underwent the orthopaedic operation were retrospectively reviewed. With using nerve electrical stimulator (Aesculap Nerve Stimulator GN 24, Tuttlingen, Germany), in neurotization procedures, phrenic nerve dysfunction is defined by no any diaphragmatic contraction was observed intraoperatively. The enrolled patients were classified into three main groups: (A) BPI patients with phrenic nerve dysfunction group, (B) BPI patients with normal phrenic nerve function group and (C) non-BPI patients group. In group A and B, we further subgroubed into: (1) for the right and (2) for the left side.

Inclusion Criteria:

  • Brachial plexus injured patients who underwent the neurotization in our institute between 2005-2008
  • Non brachial plexus injured patients who underwent the other orthopedic operation in our institute between April-June 2009

Exclusion Criteria:

  • Concomitant pneumothorax and/or hemothorax
  • Concomitant pulmonary contusion
  • Previous pulmonary disease
  • Chest wall deformity
  • Thoracic or thoracolumbar scoliosis (>10 degrees)
  • Hepatomegaly
  • Incomplete data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01450917

Sponsors and Collaborators
Mahidol University
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Principal Investigator: Saichol Wongtrakul, MD Mahidol University
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Responsible Party: Mahidol University Identifier: NCT01450917    
Other Study ID Numbers: Si442/2552(EC2)
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Respiratory Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases