Respiratory FailureDREMNCT01569217
Regional Distribution of Ventilation to Assess Respiratory Muscle Dysfunction
An observational study of Respiratory Failure and Neuromuscular Disorder, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
The aim of this study is to better discriminate respiratory muscle dysfunction by comparing the measurements of thoracoabdominal motion obtained by an optoelectronic recording and the conventional tests of respiratory muscle strength. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Neuromuscular Disorder, Diaphragmatic Paralysis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Jul 2018
- 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: Neuromuscular patients
Who may be able to join
- suspicion of respiratory muscle dysfunction
- indication of diaphragm exploration
Who cannot join
- acute respiratory failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construction of a Database to Identify Early Indicators of Respiratory Muscle Dysfunction in Neuromuscular Patients From the Optoelectronic Plethysmography Assessment of the Thoracoabdominal Motion
The aim of this study is to better discriminate respiratory muscle dysfunction by comparing the measurements of thoracoabdominal motion obtained by an optoelectronic recording and the conventional tests of respiratory muscle strength. The final objective is to better select in the future the patients who need more specific assessment of diaphragmatic function like "maximal transdiaphragmatic pressure" measurement and "phrenic nerve stimulation".
Read the detailed description
All patients which had suspected respiratory muscle dysfunction will have usual exploration of the respiratory muscles according to the clinician prescription. These explorations can include :
- Lung volumes in seating and supine position
- Maximal inspiratory and expiratory pressures
- Maximal sniff pressures
And when diaphragmatic dysfunction is suspected :
- Maximal transdiaphragmatic pressure
- Phrenic nerve conduction
These patients will also beneficiate to the determination of volume variations of the upper rib cage, the lower rib cage and the abdominal compartments by using Opto-electronic plethysmography.
- Keywords
- Diaphragm, Abdomen, Breathing pattern, dyspnea
- Medical subject headings
- Respiratory Insufficiency, Neuromuscular Diseases, Respiratory Paralysis, Dyspnea
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 |
|---|---|---|
| respiratory muscle dysfunction patients | Neuromuscular patients | |
| diaphragmatic dysfunction | patients who present orthopnea, recruitment of accessory muscles, abdominal paradox, respiratory dysfunction or dyssynchronous movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
compartmental distribution of the inspired/expired volumes
Measurements of the thoraco-abdominal motion and of the global lung volume changes.
Measurements will be done during spontaneous breathing and during vital capacity maneuvers. Therefore the tidal volume, the inspiratory capacity and the expiratory reserve volume will be measured in liters and for each compartiment (upper thorax, lower thorax, abdomen) contribution of these volumes will be expressed in percentage.
Measured: 1 hour
Secondary outcomes (1)
left side and right side contribution to the inspired/expired volumes
Measurements will be done during spontaneous breathing and during vital capacity maneuvers. Therefore the tidal volume, the inspiratory capacity and the expiratory reserve volume will be measured in liters and each side contribution of these volumes will be expressed in percentage.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startJun 2011
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lofaso, Centre d'Investigation Clinique et Technologique 805
- Investigators
- Frédéric Lofaso, MD, PhD, Principal investigator, Centre d'Investigation Clinique et Technologique 805
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569217
- Sponsor's protocol ID
- 11 003-CCP Ile de France XI
- Other IDs
- 11.155 bis
- Acronym
- DREM
- Status last verified
- Apr 2017
- First submitted
- 27 Mar 2012
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Database to Identify Early Indicators of Respiratory Muscle Dysfunction in Neuromuscular Patients From the Optoelectronic Plethysmography Assessment of the Thoracoabdominal Motion
- ClinicalTrials.gov ID
- NCT01569217
- Acronym / sponsor ID
- DREM / 11 003-CCP Ile de France XI
- Keywords
- Diaphragm, Abdomen, Breathing pattern, dyspnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 3 Apr 2012 (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.
The aim of this study is to better discriminate respiratory muscle dysfunction by comparing the measurements of thoracoabdominal motion obtained by an optoelectronic recording and the conventional tests of respiratory muscle strength. The final objective is to better select in the future the patients who need more specific assessment of diaphragmatic function like "maximal transdiaphragmatic pressure" measurement and "phrenic nerve stimulation".
Detailed description
All patients which had suspected respiratory muscle dysfunction will have usual exploration of the respiratory muscles according to the clinician prescription. These explorations can include :
- Lung volumes in seating and supine position
- Maximal inspiratory and expiratory pressures
- Maximal sniff pressures
And when diaphragmatic dysfunction is suspected :
- Maximal transdiaphragmatic pressure
- Phrenic nerve conduction
These patients will also beneficiate to the determination of volume variations of the upper rib cage, the lower rib cage and the abdominal compartments by using Opto-electronic plethysmography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| respiratory muscle dysfunction patients | – | –Neuromuscular patients |
| diaphragmatic dysfunction | – | –patients who present orthopnea, recruitment of accessory muscles, abdominal paradox, respiratory dysfunction or dyssynchronous movement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neuromuscular patients
Key inclusion criteria (2 listed)
- suspicion of respiratory muscle dysfunction
- indication of diaphragm exploration
Key exclusion criteria (1 listed)
- acute respiratory failure
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
compartmental distribution of the inspired/expired volumes
Time frame: 1 hour
Measurements of the thoraco-abdominal motion and of the global lung volume changes. Measurements will be done during spontaneous breathing and during vital capacity maneuvers. Therefore the tidal volume, the inspiratory capacity and the expiratory reserve volume will be measured in liters and for each compartiment (upper thorax, lower thorax, abdomen) contribution of these volumes will be expressed in percentage.
1 secondary outcome
left side and right side contribution to the inspired/expired volumes
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
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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.
Frédéric Lofaso, MD, PhD principal investigator
Centre d'Investigation Clinique et Technologique 805
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 Respiratory Failure and Neuromuscular Disorder, run by Centre d'Investigation Clinique et Technologique 805 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 May 2017. 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?
Results are not available in the source record.
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?
compartmental distribution of the inspired/expired volumes (time frame: 1 hour). 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 1 May 2017.