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The Use of Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support During Asynchrony in Children (NAVAChildren)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Universitario La Paz.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT01159106
First received: July 8, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

The aim of the current study is to compare the application neurally adjusted ventilatory assist (NAVA) to optimize pressure support ventilation in 12 pediatric patients.


Condition Intervention
Patient/Ventilator Asynchrony
Other: Pressure Support Ventilation
Other: Neurally adjusted ventilatory assist (NAVA)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Use of NAVA vs. Pressure Support During Asynchrony in Children

Resource links provided by NLM:


Further study details as provided by Hospital Universitario La Paz:

Primary Outcome Measures:
  • Level of asynchrony [ Time Frame: 3 hours ] [ Designated as safety issue: Yes ]
    Number of each defined forms of asynchrony per minute during pressure support and during NAVA Six forms of asynchrony will be identified during optimal pressure support and optimal NAVA: trigger asynchrony, breath initiation asynchrony and breath termination asynchrony, demand asynchrony, inspiratory asynchrony and neuro-asynchrony


Estimated Enrollment: 12
Study Start Date: July 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Pressure Support Ventilation
    Spontaneous mode of ventilation whereby the patient initiates the breath and the ventilator delivers support with the preset pressure value
    Other: Neurally adjusted ventilatory assist (NAVA)

    Gas delivery from the mechanical ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi).

    The ventilator is aware of the change in diaphragmatic EMG by the insertion of a specially designed nasogastric tube with EMG electrodes that cross the diaphragm.

Detailed Description:

Asynchrony during assisted ventilation in children is common because of the presence of uncuffed artificial airways and their rapid ventilatory rate with small volumes compared to adults.As a result, the most common approach to ventilatory support in children is pressure ventilation, since pressure targeted ventilation allows gas delivery to vary based on patient demand. In addition, many manufacturers have incorporated adjuncts designed to improve synchrony in pressure targeted ventilation. Most of today's ICU ventilators incorporate rise time and control of the breath termination criteria in pressure ventilation by either altering inspiratory time directly or adjusting the inspiratory flow termination criteria in pressure support ventilation. In addition, careful adjustment of trigger sensitivity, and insuring driving pressure is appropriately set to avoid large tidal volumes improves synchrony in many patients. However, in spite of all of these potential adjustments many pediatric patients are still asynchronous.

A recently released new mode of ventilation, NAVA (neurally adjusted ventilatory assist) is designed to reduce the asynchrony that exists between the ventilator and the patient. With NAVA, gas delivery from the mechanical ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi). The ventilator is aware of the change in diaphragmatic EMG by the insertion of a specially designed nasogastric tube (NGT) with EMG electrodes that cross the diaphragm. This NGT also functions similar to any standard NGT. NAVA is used to control all aspects of assisted ventilatory support. A number of preliminary studies in neonates and pediatric patients have demonstrated that patient ventilator synchrony is improved with the application of NAVA. In general, tidal volumes delivered by the ventilator are decreased, respiratory rates increased and peak inspiratory pressures decreased. In these studies, triggering and cycling of the ventilator are controlled by the diaphragmatic EMG in more than 70 % of the time. If the EMG signal does not activate or terminate positive pressure backup flow/pressure/time signal, control gas delivery -as is customary in standard modes of ventilatory support- takes over.

We hypothesize that the use of NAVA will improve trigger and flow synchrony in children and insure that tidal volumes are normalized (6 to 8 ml/kg) in these patients.

Asynchrony will be studied in 12 mechanically ventilated pediatric patients in the Pediatric ICU at Hospital Universitario Materno-Infantil La Paz in Madrid, Spain.

The study protocol has 5 phases

  • Phase 0: patient asynchrony documentation and 10 min recording
  • Phase 1: NAVA catheter insertion and 10 min recording in basal ventilatory mode after 20 min stabilization
  • Phase 2: Pressure support is optimized and 10 min recording after 20 min stabilization
  • Phase 3: NAVA mode ventilation and 10 min recording after 20 min stabilization
  • Phase 4: Pressure support ventilation and 10 min recording after 20 min stabilization
  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Trigger asynchrony
  • Breath initiation asynchrony
  • Breath termination asynchrony
  • Patient ventilated by Servo i (Maquet Critical Care AB,Solna,Sweden)
  • Patients breathing spontaneously with no control breaths

Exclusion Criteria:

  • Shock
  • Agitation
  • Asynchrony caused by pain
  • Abundant tracheal secretions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159106

Contacts
Contact: Pedro De La Oliva, MD, PhD poliva.hulp@salud.madrid.org

Locations
Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Pedro de la Oliva, MD PhD    +347277149    poliva.hulp@salud.madrid.org   
Principal Investigator: Pedro de la Oliva, MD PhD         
Sub-Investigator: Ana Gomez, MD         
Sub-Investigator: Cristina Schuffelmann, MD         
Sponsors and Collaborators
Hospital Universitario La Paz
Investigators
Study Director: Robert M Kacmarek, PhD RRT FCCM Massachusetts General Hospital
Principal Investigator: Pedro de la Oliva, MD PhD Hospital Universitario La Paz
Principal Investigator: Jesus Villar, MD PhD Hospital Universitario Dr. Negrin
Principal Investigator: Demet Suleymanci, MD Massachusetts General Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pedro de la Oliva, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01159106     History of Changes
Other Study ID Numbers: HULP-PI-3132
Study First Received: July 8, 2010
Last Updated: July 8, 2010
Health Authority: Spain: Ethics Committee
Spain: Ministry of Health and Consumption

Keywords provided by Hospital Universitario La Paz:
Positive Pressure Ventilation
Neurally Adjusted Ventilatory Assist
Patient/ventilator Asynchrony
Pediatric patient
Infant

ClinicalTrials.gov processed this record on November 20, 2014