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

Respiratory Paralysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450917
• Other study ID #: Si442/2552(EC2)
• Status: Completed
• Phase: N/A
• First received: October 7, 2011
• Last updated: October 10, 2011
• Start date: September 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2011
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Respiratory Paralysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cut-off point of DHI for diagnosis of phrenic nerve dysfunction		upto 3 years	No