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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Completed
CT.gov ID
NCT04360590
Collaborator
(none)
12
42.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
12 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilatory Assist (NAVA) in Difficult to Wean Pediatric ARDS Patients: a Physiologic Crossover Study
Actual Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jan 31, 2014
Actual Study Completion Date :
Jul 30, 2014

Outcome Measures

Primary Outcome Measures

  1. asynchrony index [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 Outcome Measures

  1. patient-ventilator interaction [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 2 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
SPINAZZOLA GIORGIA, Medical doctor, specialist in Anesthesia and Intensive Care Medicine, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT04360590
Other Study ID Numbers:
  • A693/CE2010
First Posted:
Apr 24, 2020
Last Update Posted:
Oct 6, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by SPINAZZOLA GIORGIA, Medical doctor, specialist in Anesthesia and Intensive Care Medicine, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021