Patient-ventilator Asynchrony During Mechanical Invasive... | NCT01193023

Studies
Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients

NCT01193023

Sponsor

University Hospital, Geneva

Status

Unknown status

Last Update Posted

Sep 1, 2010Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Respiration, Artificial

Interventions

Pressure Support
NAVA

Countries

Switzerland

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

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jun 2011Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Aug 31, 2010

First Submission Date that Met QC Criteria

Aug 31, 2010

First Posted Date

Sep 1, 2010Estimated

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

Aug 31, 2010

Last Update Posted Date

Sep 1, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to document the prevalence and type of asynchronies incidence during invasive mechanical ventilation in pediatric patients breathing under pressure support.

And to observe the impact of adjusting the expiratory trigger setting on asynchronies, and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).

Detailed Description

Two sessions will be recorded, one in PSV, one with NAVA, delivered in a random order after being sure the infant is calm and comfortable, according to his parents and/or the nurse in charge.

Criteria for initiating invasive ventilation and to start PSV will follow the usual practice guidelines of the unit.

Ventilation parameters in PS will be adjusted by the clinician in charge of the patient, as usual based on clinical observation. Investigators will not interfere with ventilator settings. Ventilation will be applied via an endotracheal tube, uncuffed for the majority (if infant < 5 years), according to commonly applied guidelines in this unit.

One 15 minutes session will be recorded, after being sure the infant is calm and comfortable according to the parents and/or the nurse in charge. Then the clinician in charge of the patient will modify the ETS, first decreasing it of 10% below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 10% above the initial set value, and will be recorded the following 5 minutes after stabilization.

NAVA will be set to deliver initially the same peak pressure (comparable level of assist) than during the initial PS period. Same PEEP will be delivered in both modes. This is possible with a pre-visualization window, allowing adjustments before switching to the NAVA mode. Nava ventilation will be recorded during 20 minutes.

The 2 sessions, Pressure support and Nava, will be recorded consecutively.

Conditions Module

Conditions

Respiration, Artificial

Keywords

Prospective Studies
Humans, pediatric
Positive-Pressure Respiration/methods*
Respiration, Artificial/methods*
Intensive Care
Intensive Care Units/statistics & numerical data*
Respiration, Artificial/statistics & numerical data*
Patients/statistics & numerical data*
Prevalence
Respiratory Muscles/innervation

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pressure support	Active Comparator	in this arm, pressure support will be recorded under 3 conditions: with the initial Expiratory Trigger Setting (ETS) with ETS +10% with ETS -10%	Other: Pressure Support
NAVA	Experimental	Neurally Adjusted ventilatory Assist is a ventilation mode where the ventilator is piloted by the electrical activity of the diaphragm Ventilation is triggered and cycled off by the electrical activity of the diaphragm, the pressure delivered being proportional to this activity.	Device: NAVA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pressure Support	Other	Ventilation under pressure support	Pressure support

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
asynchronies	Asynchronies during mechanical ventilation are the following: Auto triggering, double triggering, late cycling, premature cycling and ineffective effort. all ventilatory parameters are recorded under Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +10% and -10%, 15 min, 5 min and 5 min respectively) and NAVA (1 phase, 20 min). Asynchronies will be determined by measuring each ventilatory cycle of all recordings.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all consecutive patients from 4 weeks to 12 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical ventilation in pressure support ventilation

Exclusion Criteria:

Non treated pneumothorax
Hemodynamic instability
At least 2 hours following the admission in the PICU in post cardiac surgery
FiO2 > 0.6
Poor short term prognosis (defined as a high risk of death in the next seven days)
contraindication for gastric tube or obtention of a reliable EMGdi signal
Known esophageal problem (hiatal hernia, esophageal varicosities)
Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a naso-gastric tube
Neuromuscular disease
Patients with a pacemaker

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Weeks

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laurence Vignaux	Contact	0041223727448		laurence.vignaux@hcuge.ch
Peter Rimensberger	Contact	Tél: + 41-22 37 24 730		peter.rimensberger@hcuge.ch

Overall Officials

Name	Affiliation	Role
Peter Rimensberger, MD	Ûniversity hospital of Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital of Geneva	Recruiting	Geneva		1211	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided