Neuroregulation of BreathingRegAINNCT01818219
Effects of Abnormal Respiratory Mechanics and Assisted Mechanical Ventilation on Neuro-regulation of Respiration
A study testing Records of EADI derived parameters in people with Neuroregulation of Breathing, run by University Hospital, Angers at 1 site in France.
Trial summary
Due to recent technological improvements, it is now possible to record the electrical activity of the diaphragm (Eadi), a direct expression of the central nervous system respiratory center activity. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neuroregulation of Breathing
- What is being tested?
- Records of EADI derived parameters
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Sep 2013
- Phase
- Interventional
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man ;
- Less than 35 years old ;
- Non obese (BMI <30 kg/m2) ;
- Normal pulmonary function tests (vital capacity and forced expiratory volume in one second in the normal range for the age and size)
- No history of respiratory disease (asthma, pneumothorax) ;
- No contraindication for nasogastric tube placement
Who cannot join
- Active or past respiratory disease ;
- Contraindication to nasogastric tube placement ;
- Less than 18 years old;
- Subject protected by the law (eg subject incapable of discernment, wardship subject, ...) ;
- Subject not covered by a social security system ;
- Subject with a subordination relationship with a member of the research team.
Trial locations and contacts
1 site in 1 country.
France1 site
Medical Intensive Care Unit, University Hospital of Angers
Angers, 49933
About this study
Official title: Effects of Abnormal Respiratory Mechanics and Assisted Mechanical Ventilation on Neuro Regulation of Respiration
Due to recent technological improvements, it is now possible to record the electrical activity of the diaphragm (Eadi), a direct expression of the central nervous system respiratory center activity. By providing a relatively easy-to-use technique to record Eadi the NAVA (Neurally Adjusted Ventilatory Assist) technology offers a new opportunity to explore the effects of various interventions on neural inspiratory activity in human subjects during spontaneous and assisted ventilation both for normal and simulated abnormal respiratory mechanics.
The main aim of this project is to measure and compare the components of Eadi signal, the direct reflect of the respiratory centers activity, under various conditions of normal and simulated altered respiratory mechanics (either obstructive or restrictive respiratory mechanics° in order to better understand the neuroregulation of breathing. The second aim of the present project is to perform a similar analysis regarding the effects of various modes (Pressure Support and NAVA) and various levels of assisted ventilation both in case of normal and abnormal respiratory mechanics. Based on the information recorded on Eadi and flow and pressure signals, the last aim of this project is to correlate Eadi and pneumatic derived parameters both during spontaneous breathing and assisted ventilation.
Practically, by using the NAVA recording technology, the investigators will perform a physiological study on normal volunteers to explore the effects of normal and simulated abnormal respiratory mechanics on Eadi, flow and pressure signals (airway, oesophageal and transdiaphragmatic pressures) in order to better understand the neuroregulation of breathing. Thirty healthy volunteers with documented normal lung function tests will be included in the study (obstructive respiratory mechanics will be simulated in 15 healthy volunteers and respiratory mechanics will be simulated in 15 healthy volunteers).
- Conditions
- Neuroregulation of Breathing
- Being tested
- Records of EADI derived parameters
- Keywords
- Electrical activity of the diaphragm, Neuro regulation of breathing, Abnormal respiratory mechanics, Assisted mechanical ventilation, Pressure support, Neurally adjusted ventilatory assist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Records of EADI derived parametersProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Not described Receives: Procedure: Records of EADI derived parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eadi-time curve
Eadi time curve will be recorded. From this curve, several values will be determined for each respiratory cycle: Maximal Eadi value, area under the curve of Eadi, neural inspiratory time and Eadi slope will be measured
Measured: Continuous recording during about 6 hours
Secondary outcomes (3)
Gastric pressure-time curve
Measured: Continuous recording during about 6 hours
Oesophageal pressure-time curve
Measured: Continuous recording during about 6 hours
Pressure-time curve
Pressure-time curve will be recorded. From this curve, several values will be determined for each respiratory cycle: Maximal inspiratory value and mean airway pressure
Measured: Continuous recording during about 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Only half recruitment : restrictive respiratory mechanics group not achievable for technical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroregulation of BreathingStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818219
- Sponsor's protocol ID
- 2012/12
- Other IDs
- 2012-A01473-40
- Acronym
- RegAIN
- Status last verified
- Nov 2014
- First submitted
- 28 Feb 2013
- Last updated
- 25 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Piquilloud L, Beloncle F, Richard JM, Mancebo J, Mercat A, Brochard L. Information conveyed by electrical diaphragmatic activity during unstressed, stressed and assisted spontaneous breathing: a physiological study. Ann Intensive Care. 2019 Aug 14;9(1):89. doi: 10.1186/s13613-019-0564-1.
PubMed 31414251
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abnormal Respiratory Mechanics and Assisted Mechanical Ventilation on Neuro Regulation of Respiration
- ClinicalTrials.gov ID
- NCT01818219
- Acronym / sponsor ID
- RegAIN / 2012/12
- Conditions
- Neuroregulation of Breathing
- Keywords
- Electrical activity of the diaphragm, Neuro regulation of breathing, Abnormal respiratory mechanics, Assisted mechanical ventilation, Pressure support, Neurally adjusted ventilatory assist
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only half recruitment : restrictive respiratory mechanics group not achievable for technical problems
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 26 Mar 2013 (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.
Due to recent technological improvements, it is now possible to record the electrical activity of the diaphragm (Eadi), a direct expression of the central nervous system respiratory center activity. By providing a relatively easy-to-use technique to record Eadi the NAVA (Neurally Adjusted Ventilatory Assist) technology offers a new opportunity to explore the effects of various interventions on neural inspiratory activity in human subjects during spontaneous and assisted ventilation both for normal and simulated abnormal respiratory mechanics.
The main aim of this project is to measure and compare the components of Eadi signal, the direct reflect of the respiratory centers activity, under various conditions of normal and simulated altered respiratory mechanics (either obstructive or restrictive respiratory mechanics° in order to better understand the neuroregulation of breathing. The second aim of the present project is to perform a similar analysis regarding the effects of various modes (Pressure Support and NAVA) and various levels of assisted ventilation both in case of normal and abnormal respiratory mechanics. Based on the information recorded on Eadi and flow and pressure signals, the last aim of this project is to correlate Eadi and pneumatic derived parameters both during spontaneous breathing and assisted ventilation.
Practically, by using the NAVA recording technology, the investigators will perform a physiological study on normal volunteers to explore the effects of normal and simulated abnormal respiratory mechanics on Eadi, flow and pressure signals (airway, oesophageal and transdiaphragmatic pressures) in order to better understand the neuroregulation of breathing. Thirty healthy volunteers with documented normal lung function tests will be included in the study (obstructive respiratory mechanics will be simulated in 15 healthy volunteers and respiratory mechanics will be simulated in 15 healthy volunteers).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Procedure: Records of EADI derived parameters |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Man ;
- Less than 35 years old ;
- Non obese (BMI <30 kg/m2) ;
- Normal pulmonary function tests (vital capacity and forced expiratory volume in one second in the normal range for the age and size)
- No history of respiratory disease (asthma, pneumothorax) ;
Key exclusion criteria (6 listed)
- Active or past respiratory disease ;
- Contraindication to nasogastric tube placement ;
- Less than 18 years old;
- Subject protected by the law (eg subject incapable of discernment, wardship subject, ...) ;
- Subject not covered by a social security system ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Records of EADI derived parameters | Procedure or surgery | Study |
Primary outcome
Eadi-time curve
Time frame: Continuous recording during about 6 hours
Eadi time curve will be recorded. From this curve, several values will be determined for each respiratory cycle: Maximal Eadi value, area under the curve of Eadi, neural inspiratory time and Eadi slope will be measured
3 secondary outcomes
Gastric pressure-time curve
Time frame: Continuous recording during about 6 hours
Oesophageal pressure-time curve
Time frame: Continuous recording during about 6 hours
Pressure-time curve
Time frame: Continuous recording during about 6 hours
Results and safety
The study was stopped early (reason given: Only half recruitment : restrictive respiratory mechanics group not achievable for technical problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
- Derived from this study: PubMed 31414251Piquilloud L, Beloncle F, Richard JM, Mancebo J, Mercat A, Brochard L. Information conveyed by electrical diaphragmatic activity during unstressed, stressed and assisted spontaneous breathing: a physiological study. Ann Intensive Care. 2019 Aug 14;9(1):89. doi: 10.1186/s13613-019-0564-1.
Related trials for Neuroregulation of Breathing
RecruitingObservational study
Neural Control of Breathing in Parkinson's Disease
Parkinson Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Records of EADI derived parameters in people with Neuroregulation of Breathing, run by University Hospital, Angers 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 25 Nov 2014. 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 was stopped early (reason given: Only half recruitment : restrictive respiratory mechanics group not achievable for technical problems). 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?
Eadi-time curve (time frame: Continuous recording during about 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01818219, which also lists 1 linked publication.
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 25 Nov 2014.