Effects of Abnormal Respiratory Mechanics and Assisted Me... | NCT01818219

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

NCT01818219

Sponsor

University Hospital, Angers

Status

Terminated

Last Update Posted

Nov 25, 2014Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Neuroregulation of Breathing

Interventions

Records of EADI derived parameters

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-A01473-40	Other Identifier	IDRCB number (ANSM)

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Only half recruitment : restrictive respiratory mechanics group not achievable for technical problems

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Feb 28, 2013

First Submission Date that Met QC Criteria

Mar 21, 2013

First Posted Date

Mar 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2014

Last Update Posted Date

Nov 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study	Experimental		Procedure: Records of EADI derived parameters

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Records of EADI derived parameters	Procedure		Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Gastric pressure-time curve		Continuous recording during about 6 hours
Oesophageal pressure-time curve		Continuous recording during about 6 hours
Pressure-time curve

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Intensive Care Unit, University Hospital of Angers		Angers		49933	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31414251	Derived	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.