Unilateral Diaphragmatic ParalysisENMG-DIAPHNCT04142684
Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis
An observational study of Unilateral Diaphragmatic Paralysis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The study aims as the principal objective to compare two approaches to diagnosis unilateral diaphragmatic paralysis: transdiaphragmatic pressure (Pdi) measurement versus phrenic nerve conduction (NPC) study. The secondary objective of the study is the strengths and weaknesses of different tests. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unilateral Diaphragmatic Paralysis
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2020to 24 Feb 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients suspected unilateral diaphragmatic paralysis with available Pdi and PNC data.
Who may be able to join
- Patient ≥ 18 years;
- Available data of Pdi and PNC;
- Suspected unilateral diaphragmatic paralysis.
Who cannot join
- Abnormalities in thoracic wall which susceptible to modify the investigation's results;
- Scoliosis;
- Pleural effusion.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, France
Garches, 92380
About this study
The study aims as the principal objective to compare two approaches to diagnosis unilateral diaphragmatic paralysis: transdiaphragmatic pressure (Pdi) measurement versus phrenic nerve conduction (NPC) study.
The secondary objective of the study is the strengths and weaknesses of different tests. Diagnostic threshold values.
Read the detailed description
Inpatient patients in Raymond Poincaré hospital are informed of the utilization of their data retrospectively by the hospital's welcome booklet and reports of patients' hospitalization.
Period of date collected: November 2015 to June 2018.
The reference standard was the diagnosis established during a multidisciplinary meeting held during patient management involving a neurologist, an electrophysiologist, a pulmonologist, and a respiratory physiologist. The medical history, physical findings, and all available investigations including imaging studies, ENMG, lung function tests, and Pdi measurement were considered during the meeting.
- Conditions
- Unilateral Diaphragmatic Paralysis
- Keywords
- Unilateral Diaphragmatic Paralysis, Diagnose, Phrenic Nerve
- Medical subject headings
- Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm evaluation-compound muscle action potential
Right and left diaphragm compound muscle action potential (CMAP) : CMAP of Right and left diaphragm were elicited by transcutaneous electrical stimulation of phrenic nerves at the posterior edge of the sternocleido mastoid muscle. They are recorded with two surface electrodes positioned in the eighth intercostal space. The intensity of electrical stimulation was increased until no additional increment in diaphragm CMAP was observed. CMAP amplitude of 300µV or greater and latencies of 9 milliseconds or less were considered normal.
Measured: at 1 month
Diaphragm evaluation-transdiaphragmatic pressure
Transdiaphragmatic pressure (Pdi) was computed as the difference between gastric and esophageal pressure. Pdi was considered normal when magnetic stimulation of both phrenic nerves induced a Pdi change (Pdi Twitch) above 18 cmH2O and unilateral stimulation of each nerve induced a Pdi change (unilat-Pdi Twitch) above 4 cmH2O and ratio of the two unilat-Pdi Twitch > 0.5. and < 2.
Measured: at 1 month
Secondary outcomes (2)
Spirometry
Spirometry will be performed in the upright and supine positions. Upright vital capacity (VC) was reported as % predicted value and the difference between upright and supine VC (VC) as % upright value (normal value > 75%).
Measured: 1 month
Lung volume measurements
Lung volume measurements will be performed in the upright and supine positions. Upright vital capacity (VC) was reported as % predicted value and the difference between upright and supine VC (VC) as % upright value (normal value > 75%).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start24 Jan 2020
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Diaphragmatic ParalysisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric LOFASO, MD, PhD, Principal investigator, Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, Garches, FRANCEVivien REYNAUD, MD, Study director, Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, Garches, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142684
- Sponsor's protocol ID
- APHP190618
- Acronym
- ENMG-DIAPH
- Status last verified
- Feb 2021
- First submitted
- 26 Sep 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis
- ClinicalTrials.gov ID
- NCT04142684
- Acronym / sponsor ID
- ENMG-DIAPH / APHP190618
- Conditions
- Unilateral Diaphragmatic Paralysis
- Keywords
- Unilateral Diaphragmatic Paralysis, Diagnose, Phrenic Nerve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 29 Oct 2019 (actual)
- 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.
The study aims as the principal objective to compare two approaches to diagnosis unilateral diaphragmatic paralysis: transdiaphragmatic pressure (Pdi) measurement versus phrenic nerve conduction (NPC) study.
The secondary objective of the study is the strengths and weaknesses of different tests. Diagnostic threshold values.
Detailed description
Inpatient patients in Raymond Poincaré hospital are informed of the utilization of their data retrospectively by the hospital's welcome booklet and reports of patients' hospitalization.
Period of date collected: November 2015 to June 2018.
The reference standard was the diagnosis established during a multidisciplinary meeting held during patient management involving a neurologist, an electrophysiologist, a pulmonologist, and a respiratory physiologist. The medical history, physical findings, and all available investigations including imaging studies, ENMG, lung function tests, and Pdi measurement were considered during the meeting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suspected unilateral diaphragmatic paralysis with available Pdi and PNC data.
Key inclusion criteria (3 listed)
- Patient ≥ 18 years;
- Available data of Pdi and PNC;
- Suspected unilateral diaphragmatic paralysis.
Key exclusion criteria (3 listed)
- Abnormalities in thoracic wall which susceptible to modify the investigation's results;
- Scoliosis;
- Pleural effusion.
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
Diaphragm evaluation-compound muscle action potential
Time frame: at 1 month
Right and left diaphragm compound muscle action potential (CMAP) : CMAP of Right and left diaphragm were elicited by transcutaneous electrical stimulation of phrenic nerves at the posterior edge of the sternocleido mastoid muscle. They are recorded with two surface electrodes positioned in the eighth intercostal space. The intensity of electrical stimulation was increased until no additional increment in diaphragm CMAP was observed. CMAP amplitude of 300µV or greater and latencies of 9 milliseconds or less were considered normal.
Diaphragm evaluation-transdiaphragmatic pressure
Time frame: at 1 month
Transdiaphragmatic pressure (Pdi) was computed as the difference between gastric and esophageal pressure. Pdi was considered normal when magnetic stimulation of both phrenic nerves induced a Pdi change (Pdi Twitch) above 18 cmH2O and unilateral stimulation of each nerve induced a Pdi change (unilat-Pdi Twitch) above 4 cmH2O and ratio of the two unilat-Pdi Twitch > 0.5. and < 2.
2 secondary outcomes
Spirometry
Time frame: 1 month
Lung volume measurements
Time frame: 1 month
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 28 Sep 2021.
- Individual participant dataSharing planned: No
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.
Frédéric LOFASO, MD, PhD principal investigator
Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, Garches, FRANCE
Vivien REYNAUD, MD study director
Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, Garches, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral Diaphragmatic Paralysis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 3 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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Diaphragm evaluation-compound muscle action potential (time frame: at 1 month). The study lists 2 primary outcomes in all. 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 28 Sep 2021.