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Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI) (NavPed-NI)

Primary Purpose

Respiratory Failure, Mechanical Ventilation Complication

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Non-invasive Ventilation under Pressure Support
Non-Invasive ventilation under NAVA
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Respiratory Failure focused on measuring 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, Child, Child, Preschool, Infant, Infant, Newborn, Intensive Care Units, Pediatric, Respiratory Rate*

Eligibility Criteria

4 Weeks - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University hospital of Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Non-Invasive Pressure support

NAVA

Arm Description

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%

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 10, 2010
Last Updated
September 12, 2016
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT01238757
Brief Title
Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI)
Acronym
NavPed-NI
Official Title
Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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 non-invasive ventilation will follow the usual practice guidelines of the unit. Ventilation parameters in Non-invasive-Pressure Support 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 15% (absolute value)below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 15% (absolute value)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 non-invasive-ventilation will be recorded during 20 minutes. The 2 sessions, Pressure support and Nava, will be recorded consecutively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Mechanical Ventilation Complication
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, Child, Child, Preschool, Infant, Infant, Newborn, Intensive Care Units, Pediatric, Respiratory Rate*

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Invasive Pressure support
Arm Type
Active Comparator
Arm Description
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%
Arm Title
NAVA
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Non-invasive Ventilation under Pressure Support
Other Intervention Name(s)
NIV-PS/initial settings, NIV-PS/ETS-10%, NIV-PS/ETS+10%
Intervention Description
Non-invasive Ventilation under Pressure Support: 15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order
Intervention Type
Other
Intervention Name(s)
Non-Invasive ventilation under NAVA
Other Intervention Name(s)
Neurally Adjusted ventilatory Assist, Neural ventilation, Diaphragmatic electrical activity ventilation
Intervention Description
20 min session under non-invasive ventilation with NAVA
Primary Outcome Measure Information:
Title
asynchronies
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Rimensberger, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Geneva
City
Geneva
State/Province
GE
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

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Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI)

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