Noninvasive NAVA Versus Flow-triggered Noninvasive Pressure Support in Pediatric Respiratory Failure

NCT03697863 | Unknown

• 1 other identifier: 698-2017
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Acute Hypoxemic Respiratory Failure (AHRF) is a leading cause of admission in Pediatric Intensive Care Unit (PICU). Traditional treatment includes endotracheal intubation and mechanical ventilation, that are invasive and not free from risks. Recent experiences from pediatric studies showed that Non-Invasive Pressure Support Ventilation (NIV-PS) has been associated with lower intubation rate, adverse events and mortality compared to mechanical ventilation delivered by an endotracheal tube. Nonetheless, in pediatric ARF, the application of a well-synchronized NIV-PS is technically challenging due to the presence of leaks and the age-specific characteristics of pediatric respiratory pattern (high respiratory rate, short inspiratory/expiratory time and weak inspiratory effort). Consequently, NIV-PS often results in difficult patient-ventilator interaction, with a failure rate up to 43% . Neurally Adjusted Ventilatory Assist (NAVA) is a new form of ventilatory assistance wherein the ventilator applies positive pressure throughout inspiration synchronously and proportionally to the Electrical Diaphragm activity (Edi). Thus, NAVA is not influenced by large leaks around uncuffed endotracheal tubes or noninvasive interfaces. Studies in intubated children found that NAVA improved interaction by reducing asynchronies and optimizing ventilator cycling.Two recent studies showed that the application of Non-Invasive NAVA (NIV-NAVA) in children with ARF is feasible and may reduce asynchronies as compared to NIV-PS. More recently, in a recent RCT of our group, we demonstrated that NIV NAVA in children was associated with lower asynchronies, longer synchronization time between patient and ventilator at lower peak and mean airway pressure. However no data are published to address the question if the better synchronization between patients and ventilator obtained with NIV NAVA could lead to a reduction in intubation rate and PICU outcomes. To address this question, we designed an observational retrospective study aiming to define if early delivered NIV NAVA could reduce intubation rate if compared with traditionally flow-cycled NIV PS in hypoxemic children admitted to PICU.

Conditions

Acute Respiratory Failure

Keywords

Neurally Adjusted Ventilatory Assist

Outcome Measures

Primary Outcomes (1)

• Intubation rate

  Frequency of intubation between the two treatment

  First 48 hours from PICU admission

Study Arms (2)

Noninvasive Adjusted Ventilatory Assist

Procedure: Noninvasive Respiratory Support

Noninvasive Pressure Support

Procedure: Noninvasive Respiratory Support

Interventions

Noninvasive Respiratory Support PROCEDURE

Noninvasive Respiratory Support delivered by conventional flow triggered ventilation or neurally triggered ventilatory assist

Noninvasive Adjusted Ventilatory Assist; Noninvasive Pressure Support

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive children with infectious Acute Respiratory Failure meeting the pediatric criteria for moderate ARDS Definition admitted to PICU of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy between the first January 2015 and first January 2017.

You may qualify if:

• Age \> 1month and \< 5 years; paO2: FIO2 \<300 with oxygen mask (FiO2=0.4) for 15 minutes Respiratory Rate (RR)\>2SD according to age Bilateral Chest X ray infiltrates Absence of cardiopathy diagnosed by ecochardiography .

You may not qualify if:

• Emergency need for intubation Glasgow Coma Scale \<12 pH\<7.25 Cough reflex impairment Upper-airway obstruction Hemodynamic instability (need for vasopressor or inotropes) Evidence of pneumothorax on lung echo or chest x ray Esophageal surgery, neuromuscular, mitochondrial, metabolic or chromosomal diseases with baby hypotonia and lesions of medulla.
• Were excluded even patients whose parents denied the consent to manage personal data at admission and patient lacking data on medical charts report

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (3)

• 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 RESULT

• Vignaux L, Grazioli S, Piquilloud L, Bochaton N, Karam O, Levy-Jamet Y, Jaecklin T, Tourneux P, Jolliet P, Rimensberger PC. Patient-ventilator asynchrony during noninvasive pressure support ventilation and neurally adjusted ventilatory assist in infants and children. Pediatr Crit Care Med. 2013 Oct;14(8):e357-64. doi: 10.1097/PCC.0b013e3182917922.

  PMID: 23863816 RESULT

• Chidini G, De Luca D, Conti G, Pelosi P, Nava S, Calderini E. Early Noninvasive Neurally Adjusted Ventilatory Assist Versus Noninvasive Flow-Triggered Pressure Support Ventilation in Pediatric Acute Respiratory Failure: A Physiologic Randomized Controlled Trial. Pediatr Crit Care Med. 2016 Nov;17(11):e487-e495. doi: 10.1097/PCC.0000000000000947.

  PMID: 27749511 RESULT

Study Officials

• Giovanna Chidini, MD

  Fondazione IRCCS Ca granda Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 5, 2018
• Study Start: October 3, 2018
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: October 5, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)