Pressure Support Ventilation Versus Neurally Adjusted Ventilatory Assist in Difficult to Wean Pediatric Patients

Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilatory Assist (NAVA) in Difficult to Wean Pediatric ARDS Patients: a Physiologic Crossover Study

This study assessed the effects of NAVA versus Pressure Support Ventilation (PSV) on patient-ventilator interaction in pediatric patients with difficult weaning from mechanical ventilation after moderate Pediatric Acute Respiratory Distress Syndrome (PARDS).

Study Overview

• Status: Completed
• Conditions: Weaning Failure; Distress Respiratory Syndrome
• Intervention / Treatment: Device: pressure support ventilation versus neurally adjusted ventilatory assist

Detailed Description

12 pediatric patients, admitted in Pediatric Intensive Care Unit (PICU) with moderate PARDS and who failed up to 3 SBTs in less than 7 days, were enrolled in this study. These patients underwent three studies conditions, lasting 1 hour each: Pressure support ventilation 1, Neurally adjusted ventilatory assist and Pressure support ventilation 2.

During each trial were recorded the patient tracings of flow, airway pressure and electrical activity of diaphragm for the patient-ventilator interaction analysis.

• Study Type: Observational
• Enrollment (Actual): 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

during the study, all patients (older than 1 month and younger than 2 years) admitted to Pediatric Intensive Care Unit for moderate pediatric Acute Respiratory Distress Syndrome and ready for weaning from mechanical ventilation were evaluated.

All patients who failed up to 3 SBTs taking less than 7 days, presenting at least two of the following signs: diaphoresis, nasal flaring, tachycardia (Heart Rate increase ≥ 40 bpm) cardiac arrhythmias, hypotension, apnea, PETCO2 increase > 10 mmHg, decrease of arterial pH < 7.32, PaO2 < 60mmHg with an FiO2 ≥ 0.40 (PaO2/FiO2 less than 150), were enrolled in the study.

Description

Inclusion Criteria:

• diagnosis of moderate PARDS
• 3 spontaneous breathing trials failed in less than 7 days

Exclusion Criteria:

• hemodynamic instability
• severe respiratory instability
• contraindication to nasogastric tube exchange
• increase in intracranial pressure
• palliative care for end-stage oncologic disease
• neuromuscular disease
• lesions of medulla

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
asynchrony index	in each study condition, the asynchrony index was measured. The asynchrnony index value grater than 10% is an indicator of worsening patient-ventilator interaction. the Asynchrony Index is the ratio between the number of asynchronous events and the total respiratory rate, expressed as percentage	three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient-ventilator interaction	the variable describing patient-ventilator interaction is the inspiratory trigger delay (defined as the time lag between the onset of neural inspiration and the onset of ventilatory assistance and measured in milliseconds )	three years
interaction	another variable describing patient-ventilator interaction is the expiratory trigger delay ( defined as the time lag between the neural expiration and the end of mechanical assistance and measured in milliseconds)	three years
synchrony between patient and mechanical ventilator	the time of synchrony is the time during which the patient inspiratory effort and the ventilatory assistance are in phase and measured in milliseconds).	three years

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Study Director: Giorgio P Conti, Prof, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

General Publications

• Breatnach C, Conlon NP, Stack M, Healy M, O'Hare BP. A prospective crossover comparison of neurally adjusted ventilatory assist and pressure-support ventilation in a pediatric and neonatal intensive care unit population. Pediatr Crit Care Med. 2010 Jan;11(1):7-11. doi: 10.1097/PCC.0b013e3181b0630f.
• Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.
• Bordessoule A, Emeriaud G, Morneau S, Jouvet P, Beck J. Neurally adjusted ventilatory assist improves patient-ventilator interaction in infants as compared with conventional ventilation. Pediatr Res. 2012 Aug;72(2):194-202. doi: 10.1038/pr.2012.64.
• Blanch L, Villagra A, Sales B, Montanya J, Lucangelo U, Lujan M, Garcia-Esquirol O, Chacon E, Estruga A, Oliva JC, Hernandez-Abadia A, Albaiceta GM, Fernandez-Mondejar E, Fernandez R, Lopez-Aguilar J, Villar J, Murias G, Kacmarek RM. Asynchronies during mechanical ventilation are associated with mortality. Intensive Care Med. 2015 Apr;41(4):633-41. doi: 10.1007/s00134-015-3692-6. Epub 2015 Feb 19.
• Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350.
• Blokpoel RG, Burgerhof JG, Markhorst DG, Kneyber MC. Patient-Ventilator Asynchrony During Assisted Ventilation in Children. Pediatr Crit Care Med. 2016 May;17(5):e204-11. doi: 10.1097/PCC.0000000000000669.
• Spinazzola G, Costa R, De Luca D, Chidini G, Ferrone G, Piastra M, Conti G. Pressure Support Ventilation (PSV) versus Neurally Adjusted Ventilatory Assist (NAVA) in difficult to wean pediatric ARDS patients: a physiologic crossover study. BMC Pediatr. 2020 Jul 7;20(1):334. doi: 10.1186/s12887-020-02227-1.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): January 31, 2014
• Study Completion (Actual): July 30, 2014

Study Registration Dates

• First Submitted: April 18, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: difficult weaning; patient-ventilator interaction; pediatric acute respiratory distress syndrome
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: A693/CE2010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No