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

NCT04360590 | Completed

• 1 other identifier: A693/CE2010
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Distress Respiratory Syndrome; Weaning Failure

Keywords

patient-ventilator interaction; pediatric acute respiratory distress syndrome; difficult weaning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• patient-ventilator interaction

  three years

• interaction

  three years

• synchrony between patient and mechanical ventilator

  three years

Interventions

pressure support ventilation versus neurally adjusted ventilatory assist DEVICE

All patients underwent three mechanical ventilation modes, lasting 1 hour each: pressure support mode, neurally adjusted ventilatory assist and again pressure support ventilation

Eligibility Criteria

• Age: 1 Month - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Related Publications (7)

• 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.

  PMID: 25693449 BACKGROUND

• 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.

  PMID: 26914624 BACKGROUND

• 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.

  PMID: 16896854 BACKGROUND

• 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.

  PMID: 22580718 BACKGROUND

• 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.

  PMID: 19593246 BACKGROUND

• 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.

  PMID: 25647235 BACKGROUND

• 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.

  PMID: 32631305 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Giorgio P Conti, Prof

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, specialist in Anesthesia and Intensive Care Medicine

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: April 24, 2020
• Study Start: January 1, 2011
• Primary Completion: January 31, 2014
• Study Completion: July 30, 2014
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share