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

NCT ID: NCT01238757

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-09-30

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.

Conditions

Respiratory Failure; Mechanical Ventilation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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%

Group Type: ACTIVE_COMPARATOR

Non-invasive Ventilation under Pressure Support

Intervention Type: OTHER

Non-invasive Ventilation under Pressure Support:

15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order

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

Group Type: ACTIVE_COMPARATOR

Non-Invasive ventilation under NAVA

Intervention Type: OTHER

20 min session under non-invasive ventilation with NAVA

Interventions

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

Intervention Type: OTHER

Non-Invasive ventilation under NAVA

20 min session under non-invasive ventilation with NAVA

Intervention Type: OTHER

Other Intervention Names

NIV-PS/initial settings; NIV-PS/ETS-10%; NIV-PS/ETS+10%; Neurally Adjusted ventilatory Assist; Neural ventilation; Diaphragmatic electrical activity ventilation

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

• Minimum Eligible Age: 4 Weeks
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Peter C. Rimensberger

Dr Peter Romensberger

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Rimensberger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

University hospital of Geneva

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

Other Identifiers

HUG-matped 09-054

Identifier Type: -

Identifier Source: org_study_id