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

NCT01818219 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-11-25

No results posted yet for this study

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).

Conditions

  • Neuroregulation of Breathing

Interventions

PROCEDURE

Records of EADI derived parameters

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01818219 on ClinicalTrials.gov