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

NCT ID: NCT04360590

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2014-07-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Distress Respiratory Syndrome Weaning Failure

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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pressure support ventilation versus neurally adjusted ventilatory assist

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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SPINAZZOLA GIORGIA

Medical doctor, specialist in Anesthesia and Intensive Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giorgio P Conti, Prof

Role: STUDY_DIRECTOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

References

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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.

Reference Type BACKGROUND
PMID: 25693449 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26914624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16896854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22580718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19593246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25647235 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32631305 (View on PubMed)

Other Identifiers

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A693/CE2010

Identifier Type: -

Identifier Source: org_study_id

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