Neuroregulation of Breathing Clinical Trial
— RegAINOfficial 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).
| Status | Terminated |
| Enrollment | 15 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 35 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| France | Medical Intensive Care Unit, University Hospital of Angers | Angers |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Angers |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Continuous recording during about 6 hours | No |
| Secondary | Gastric pressure-time curve | Continuous recording during about 6 hours | No | |
| Secondary | Oesophageal pressure-time curve | Continuous recording during about 6 hours | No | |
| Secondary | 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 | Continuous recording during about 6 hours | No |