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

Respiratory Failure Clinical Trial

— NavPed-NI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238757
• Other study ID #: HUG-matped 09-054
• Status: Completed
• Phase: N/A
• First received: November 10, 2010
• Last updated: September 12, 2016
• Start date: June 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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
• Non-Invasive ventilation under NAVA
20 min session under non-invasive ventilation with NAVA

Locations

Country	Name	City	State
Switzerland	University hospital of Geneva	Geneva	GE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No