Impact of NAVA (Neurally Adjusted Ventilatory Assist) on Ventilatory Demand During Pediatric Non-Invasive Ventilation

NCT02163382 | Completed

• 1 other identifier: CHUSJ-3388
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical ventilation permits to support the work of breathing in case of respiratory failure, but therapy also has many side effects. Non-invasive ventilation (NIV), which delivers the ventilatory assist via a face mask or nasal canula, permits to decrease these complications. However, NIV is not always successful and half of children in respiratory failure finally require invasive ventilation. A major cause of NIV failure is the ventilator inability to detect patient efforts. The new ventilatory mode NAVA (neurally adjusted ventilatory assist) improves the detection of patient efforts during mechanical ventilation. The hypothesis of this study is that NAVA improves synchrony during pediatric NIV and therefore permits to unload the patient ventilatory efforts.

Conditions

Respiratory Failure

Keywords

Nava; Non Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

• The ventilatory demand of the patient in each ventilatory conditions, evaluated by the mean electrical diaphragmatic activity

  The analysis of respiratory recordings will be conducted on 15 minute period during which the patient is not agitated, at the end of the 3 ventilation periods: baseline period with conventional parameters, NAVA period, and 2nd period with conventional parameters. The mean EAdi will be calculated as the area under the curve of EAdi versus time

  up to 28 days

Secondary Outcomes (1)

• Percentage of time spent in asynchrony

  Up to 28 days

Other Outcomes (1)

• Ability to obtain a correct EAdi signal

  Up to 28 days

Study Arms (1)

Neurovent Monitor XIII

EXPERIMENTAL

1 hour Ventilation with NAVA

Device: Neurovent Monitor XIII

Interventions

Neurovent Monitor XIII DEVICE

Nasogastric tiube installation to monitor EAdi

Also known as: Health Canada approval number: 186536

Neurovent Monitor XIII

Eligibility Criteria

• Age: 3 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children \>3 days and \<18 years old
• Hospitalized in the pediatric intensive care unit, and requiring non invasive ventilation (including any ventilatory modes, with one (CPAP) or two level of pressure assist) for more than 6 hours according to the prescription of the attending physician

You may not qualify if:

• Contraindications to NAVA use or to the placement of a new nasogastric tube (e.g. bilateral phrenic paralysis, trauma or recent surgery in cervical, nasopharyngeal or esophageal regions)
• Hemodynamic instability requiring dopamine ≥ 5µg/kg/min, epinephrine, norepinephrine, or dobutamine.
• Severe respiratory instability requiring imminent intubation according to the attending physician, or FiO2 \> 60%, or PaCO2\>80 mmHg on blood gas in the last hour.
• Absence of parental or tutor consent.
• Patient for whom a limitation of life support treatments is discussed or decided

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

Guillaume Emeriaud

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

• Ducharme-Crevier L, Beck J, Essouri S, Jouvet P, Emeriaud G. Neurally adjusted ventilatory assist (NAVA) allows patient-ventilator synchrony during pediatric noninvasive ventilation: a crossover physiological study. Crit Care. 2015 Feb 17;19(1):44. doi: 10.1186/s13054-015-0770-7.

  PMID: 25886793 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Philippe A Jouvet, MD, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Sylvain Morneau

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Jennifer Beck, PhD

  Li Ka Shing Knowledge Institute. St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 13, 2014
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 23, 2015

Record last verified: 2015-11

Locations

CA (1)