Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163382
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : November 23, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Guillaume Emeriaud, St. Justine's Hospital

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: Neurovent Monitor XIII Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of NAVA (Neurally Adjusted Ventilatory Assist) on Ventilatory Demand During Pediatric Non-Invasive Ventilation
Study Start Date : November 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neurovent Monitor XIII
1 hour Ventilation with NAVA
Device: Neurovent Monitor XIII
Nasogastric tiube installation to monitor EAdi
Other Name: Health Canada approval number: 186536

Device: Neurovent Monitor XIII
RIP jacket installation

Device: Neurovent Monitor XIII
Ventilator change (if a different ventilator was used prior to the study).

Device: Neurovent Monitor XIII
Determination of NAVA parametersVentilator

Device: Neurovent Monitor XIII
Second period with conventional NIV settings




Primary Outcome Measures :
  1. The ventilatory demand of the patient in each ventilatory conditions, evaluated by the mean electrical diaphragmatic activity [ Time Frame: up to 28 days ]
    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


Secondary Outcome Measures :
  1. Percentage of time spent in asynchrony [ Time Frame: Up to 28 days ]
    The inspiratory and expiratory times of the patient and of the ventilator will be identified cycle-by-cycle from the tracing of EAdi and airway pressure, respectively. The percentage of time spent in asynchrony (discordance between the patient and the ventilator actions) will be calculated [Beck 2004], as well as the delay to activate or inactivate the ventilatory support. The number of non-assisted breaths (increase in EAdi without pressure elevation) and of auto-triggered breaths (assist delivered in absence of EAdi activation) will also be counted [Thille 2006; Vignaux 2009].


Other Outcome Measures:
  1. Ability to obtain a correct EAdi signal [ Time Frame: Up to 28 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163382


Locations
Layout table for location information
Canada, Quebec
Guillaume Emeriaud
Montréal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Layout table for investigator information
Principal Investigator: 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr Guillaume Emeriaud, MD, PhD, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02163382    
Other Study ID Numbers: CHUSJ-3388
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: November 23, 2015
Last Verified: November 2015
Keywords provided by Dr Guillaume Emeriaud, St. Justine's Hospital:
Nava
Non Invasive Ventilation
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases