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CompletedNCT04360590Updated Oct 6, 2021

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

An observational study in Distress Respiratory Syndrome and Weaning Failure, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed. Open to participants aged 1 Month to 2 Years. Per ClinicalTrials.gov, last updated 2021-10-06.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
12
Ages
1 Month to 2 Years
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Distress Respiratory Syndrome
  • Weaning Failure

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Keywords

  • patient-ventilator interaction
  • pediatric acute respiratory distress syndrome
  • difficult weaning
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In context

Pulmonary Atelectasis

308 studies on the registry are indexed under Pulmonary Atelectasis; 79 are open to participants now.

This study's enrollment of 12 is below the median of 72 across 76 observational studies indexed under Pulmonary Atelectasis.

Browse Pulmonary Atelectasis studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 948 studies on the registry; 537 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Interventions

  • Devicepressure 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

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What researchers measure

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

    Time frame: three years

Secondary outcomes

  1. 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 )

    Time frame: three years

  2. 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)

    Time frame: three years

  3. 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).

    Time frame: three years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 25693449 ↗
  • 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. PubMed 26914624 ↗
  • 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. PubMed 16896854 ↗
  • 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. PubMed 22580718 ↗
  • 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. PubMed 19593246 ↗
  • 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. PubMed 25647235 ↗
  • 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. PubMed 32631305 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04360590
Responsible party
SPINAZZOLA GIORGIA (Medical doctor, specialist in Anesthesia and Intensive Care Medicine, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Apr 24, 2020
Start date
Jan 1, 2011
Primary completion
Jan 31, 2014
Completion
Jul 30, 2014
Last update
Oct 6, 2021

Study contacts

Giorgio P Conti, Prof
study director · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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