NCT01238757

Brief Summary

The purpose of this study is

  • to document the prevalence and type of asynchronies incidence during non-invasive mechanical ventilation in pediatric patients breathing under pressure support.
  • to observe the impact of adjusting the expiratory trigger setting on asynchronies during pressure support
  • and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

November 10, 2010

Last Update Submit

September 12, 2016

Conditions

Respiratory FailureMechanical Ventilation Complication

Keywords

Prospective StudiesHumans, pediatricPositive-Pressure Respiration/methods*Respiration, Artificial/methods*Intensive CareIntensive Care Units/statistics & numerical data*Respiration, Artificial/statistics & numerical data*Patients/statistics & numerical data*PrevalenceRespiratory Muscles/innervationChildChild, PreschoolInfantInfant, NewbornIntensive Care Units, PediatricRespiratory Rate*

Outcome Measures

Primary Outcomes (1)

  • 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 non-invasive-Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +15% and -15%, 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

Study Arms (2)

Non-Invasive Pressure support

ACTIVE COMPARATOR

in this arm, non-invasive pressure support will be recorded under 3 conditions: with the initial Expiratory Trigger Setting (ETS) with ETS +15% with ETS -15%

Other: Non-invasive Ventilation under Pressure Support

NAVA

ACTIVE COMPARATOR

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. The proportion named gain is chosen to obtain under NAVA the same peak pressure than during Presure Support

Other: Non-Invasive ventilation under NAVA

Interventions

Non-invasive Ventilation under Pressure SupportOTHER

Non-invasive Ventilation under Pressure Support: 15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order

Also known as: NIV-PS/initial settings, NIV-PS/ETS-10%, NIV-PS/ETS+10%
Non-Invasive Pressure support
Non-Invasive ventilation under NAVAOTHER

20 min session under non-invasive ventilation with NAVA

Also known as: Neurally Adjusted ventilatory Assist, Neural ventilation, Diaphragmatic electrical activity ventilation
NAVA

Eligibility Criteria

Age4 Weeks - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all consecutive patients from 4 weeks to 5 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical non-invasive ventilation in pressure support ventilation

You may not qualify if:

  • Non treated pneumothorax
  • Hemodynamic instability
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Respiratory InsufficiencyRespiratory Aspiration

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Peter Rimensberger, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Peter Romensberger

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 11, 2010

Study Start

June 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

CH(1)