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

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT01450917
Collaborator
(none)
245
Enrollment
30
Duration (Days)

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Sep 1, 2009
    Actual Primary Completion Date :
    Oct 1, 2009
    Actual Study Completion Date :
    Oct 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. The cut-off point of DHI for diagnosis of phrenic nerve dysfunction [upto 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Saichol Wongtrakul, MD, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT01450917
    Other Study ID Numbers:
    • Si442/2552(EC2)
    First Posted:
    Oct 12, 2011
    Last Update Posted:
    Oct 12, 2011
    Last Verified:
    Oct 1, 2011
    Additional relevant MeSH terms:
    Respiratory Paralysis
    Paralysis

    Study Results

    No Results Posted as of Oct 12, 2011