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Effects of Abnormal Respiratory Mechanics and Assisted Mechanical Ventilation on Neuro-regulation of Respiration (RegAIN)

Primary Purpose

Neuroregulation of Breathing

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Records of EADI derived parameters
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neuroregulation of Breathing focused on measuring Electrical activity of the diaphragm, Neuro regulation of breathing, Abnormal respiratory mechanics, Assisted mechanical ventilation, Pressure support, Neurally adjusted ventilatory assist

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Medical Intensive Care Unit, University Hospital of Angers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Gastric pressure-time curve
Oesophageal pressure-time curve
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

Full Information

First Posted
February 28, 2013
Last Updated
November 24, 2014
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01818219
Brief Title
Effects of Abnormal Respiratory Mechanics and Assisted Mechanical Ventilation on Neuro-regulation of Respiration
Acronym
RegAIN
Official Title
Effects of Abnormal Respiratory Mechanics and Assisted Mechanical Ventilation on Neuro Regulation of Respiration
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Only half recruitment : restrictive respiratory mechanics group not achievable for technical problems
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Records of EADI derived parameters
Primary Outcome Measure Information:
Title
Eadi-time curve
Description
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
Time Frame
Continuous recording during about 6 hours
Secondary Outcome Measure Information:
Title
Gastric pressure-time curve
Time Frame
Continuous recording during about 6 hours
Title
Oesophageal pressure-time curve
Time Frame
Continuous recording during about 6 hours
Title
Pressure-time curve
Description
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
Time Frame
Continuous recording during about 6 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Medical Intensive Care Unit, University Hospital of Angers
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31414251
Citation
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.
Results Reference
derived

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Effects of Abnormal Respiratory Mechanics and Assisted Mechanical Ventilation on Neuro-regulation of Respiration

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