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Completed

NCT Number: NCT04360590

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

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).

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Key information

Conditions

Distress Respiratory Syndrome Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases Weaning Failure

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. asynchrony index

    Time frame: three years

    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

Secondary outcomes

  1. patient-ventilator interaction

    Time frame: three years

    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 )

  2. interaction

    Time frame: three years

    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)

  3. synchrony between patient and mechanical ventilator

    Time frame: three years

    the time of synchrony is the time during which the patient inspiratory effort and the ventilatory assistance are in phase and measured in milliseconds).

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 24, 2020
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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