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

Sponsor

University Hospital, Geneva (Other)

Overall Status

Completed

CT.gov ID

NCT01238757

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure Mechanical Ventilation Complication	Other: Non-invasive Ventilation under Pressure Support Other: Non-Invasive ventilation under NAVA	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Non-Invasive Pressure support 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 Non-invasive Ventilation under Pressure Support: 15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order Other Names: NIV-PS/initial settings NIV-PS/ETS-10% NIV-PS/ETS+10%
Active Comparator: NAVA 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 20 min session under non-invasive ventilation with NAVA Other Names: Neurally Adjusted ventilatory Assist Neural ventilation Diaphragmatic electrical activity ventilation

Arm

Intervention/Treatment

Active Comparator: Non-Invasive Pressure support

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

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

Other Names:

NIV-PS/initial settings

NIV-PS/ETS-10%

NIV-PS/ETS+10%

Active Comparator: NAVA

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

20 min session under non-invasive ventilation with NAVA

Other Names:

Neurally Adjusted ventilatory Assist

Neural ventilation

Diaphragmatic electrical activity ventilation

Outcome Measures

Primary Outcome Measures

asynchronies [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Weeks to 5 Years

Sexes Eligible for Study:

All

Accepts 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