Respiratory ParalysisNCT01450917
Diaphragmatic Height Index: the New Diagnostic Test for Phrenic Nerve Dysfunction
An observational study of Respiratory Paralysis, run by Mahidol University.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Respiratory Paralysis
- How many people
- 245 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Concomitant pneumothorax and/or hemothorax
- Concomitant pulmonary contusion
- Previous pulmonary disease
- Chest wall deformity
- Thoracic or thoracolumbar scoliosis (>10 degrees)
- Hepatomegaly
- Incomplete data
About this study
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
- Medical subject headings
- Respiratory Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cut-off point of DHI for diagnosis of phrenic nerve dysfunction
Measured: upto 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startSep 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory ParalysisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saichol Wongtrakul, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450917
- Sponsor's protocol ID
- Si442/2552(EC2)
- Status last verified
- Oct 2011
- First submitted
- 7 Oct 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Height Index: the New Diagnostic Test for Phrenic Nerve Dysfunction
- ClinicalTrials.gov ID
- NCT01450917
- Acronym / sponsor ID
- Si442/2552(EC2)
- Conditions
- Respiratory Paralysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- Concomitant pneumothorax and/or hemothorax
- Concomitant pulmonary contusion
- Previous pulmonary disease
- Chest wall deformity
- Thoracic or thoracolumbar scoliosis (>10 degrees)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The cut-off point of DHI for diagnosis of phrenic nerve dysfunction
Time frame: upto 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saichol Wongtrakul, MD principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Paralysis, run by Mahidol University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cut-off point of DHI for diagnosis of phrenic nerve dysfunction (time frame: upto 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.