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

NCT01450917 | Completed

• 1 other identifier: Si442/2552(EC2)
• Study Type: observational
• Target: 245
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Paralysis

Outcome Measures

Primary Outcomes (1)

• The cut-off point of DHI for diagnosis of phrenic nerve dysfunction

  upto 3 years

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

MeSH Terms

Conditions

Respiratory Paralysis

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Saichol Wongtrakul, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 12, 2011
• Study Start: September 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 12, 2011

Record last verified: 2011-10