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Neurally Adjusted Ventilatory Assist (NAVA) vs. Pressure Support in Pediatric Acute Respiratory Failure (NiNAVAped)

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ClinicalTrials.gov Identifier: NCT01873521
Recruitment Status : Unknown
Verified April 2014 by Ignacio Galicia, Hospital Universitario La Paz.
Recruitment status was:  Recruiting
First Posted : June 10, 2013
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Ignacio Galicia, Hospital Universitario La Paz

Tracking Information
First Submitted Date  ICMJE June 6, 2013
First Posted Date  ICMJE June 10, 2013
Last Update Posted Date April 16, 2014
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2013)
Avoiding endotracheal intubation [ Time Frame: During non invasive ventilation, an average of 2-3 days. ]
The primary objective of this study is to demonstrate that the use of NAVA to provide noninvasive ventilatory support (NIV NAVA) compared to pressure support (NIV PS) in pediatric patients with moderate to severe respiratory failure decreases the noninvasive ventilation failure rate by decreasing the number of patients requiring endotracheal intubation (ETI).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01873521 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2013)
  • Length (days) of PICU stay after NIV [ Time Frame: Length (days) of PICU stay after NIV, an average of 1 week. ]
  • Length (days) hospital stay after NIV [ Time Frame: Length (days) hospital stay after NIV, an average of 1-2 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurally Adjusted Ventilatory Assist (NAVA) vs. Pressure Support in Pediatric Acute Respiratory Failure
Official Title  ICMJE A Multicentre, Randomized, Clinical Trial of Noninvasive Ventilation: Neurally Adjusted Ventilatory Assist (NAVA) vs. Pressure Support in Pediatric Acute Respiratory Failure - NINAVAPed Protocol
Brief Summary It is hypothesized that the use of Neurally Adjusted Ventilatory Assist (NAVA) compared to pressure support to provide noninvasive ventilation to children will result in a decrease in the number of children with moderate to severe respiratory failure failing noninvasive ventilation and requiring endotracheal intubation. It is further hypothesized that noninvasive ventilation with NAVA compared to pressure support will result in a decrease in the length of mechanical ventilation, and the length of PICU and hospital stay.
Detailed Description

Mechanical ventilation (MV) refers to the use of life-support technology to perform the work of breathing for patients who are unable to breathe on their own. One of the most common reasons for a Pediatric Intensive Care Unit (PICU) admission is the need for mechanical ventilation. However, MV is associated with increased morbidity (endotracheal intubation, tracheal edema, atelectasis, cardiovascular instability, ventilator-associated pneumonia, bleeding, pneumothorax, chronic lung disease, etc), a long length of stay in the PICU and high health care costs. Noninvasive ventilation (NIV) has become a primary approach to ventilatory support of patients of all ages and it is estimated that it can avoid endotracheal intubation and replace conventional mechanical ventilation in around 60% of patients with acute respiratory failure. NIV has been shown to ameliorate clinical signs of failure and improve gas exchange while reducing the need for endotracheal intubation (ETI) thus avoiding the risks associated with invasive ventilation. NIV has been shown to decrease the length of mechanical ventilation, the risk of ventilator associated pneumonia, the sedation requirement, the length of ICU and hospital stay and mortality, while improving the ability to tolerate enteral feeds. NIV does not increase beside caregiver time and does decrease cost.

With children because of the difficulty in assuring the patient's cooperation, the lack of available high quality masks and the resulting size of the air leak, synchrony between the ventilatory pattern of the patient and the support provided by the ventilator is poor. This problem had lead to repeated failure of noninvasive ventilation in children. The primary mode of noninvasive ventilatory support is pressure support (NIV PS). This mode is triggered to inspiration and cycled to exhalation by changes in patient inspiratory gas flow. But with air leaks the ability of the ventilator to coordinate with the patient is decreased.

A new mode of ventilation, Neurally Adjusted Ventilatory Assist (NAVA) has been recently introduced. This mode triggers, cycles and regulates gas delivery based on the diaphragmatic EMG signal via a specially designed nasogastric tube (Edi). As a result, air leaks do not affect the ability of the ventilator to synchronize gas delivery with the patient increasing patient ventilator synchrony. Based on the operation of NAVA it is expected to increase the successful application of noninvasive ventilation to children.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Pediatric Acute Respiratory Failure
Intervention  ICMJE Procedure: Non invasive ventilation
Study Arms  ICMJE
  • Active Comparator: NIV PS
    The patients in this arms will received non invasive ventilation in PS mode.
    Intervention: Procedure: Non invasive ventilation
  • Active Comparator: NIV NAVA
    The patients in this arm will received non invasive ventilation in NAVA mode.
    Intervention: Procedure: Non invasive ventilation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 7, 2013)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age > 1 month age or weight > 3 Kg to 18 years
  2. Not intubated.
  3. Admitted to the PICU.
  4. Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2).
  5. Moderate/severe Pediatric Acute Respiratory failure of any origin evaluated after a period of respiratory stabilization (aspiration of secretions, physiotherapy, oxygen and nebulized therapy) defined as: a) Modified Silverman-Wood Downess test >or= 5 or <or= 9; b) Hypoxemic ARF(SpO2< 94% FiO2 0,5). c)Hypercapnic ARF (PaCO2 (mmHg) and/or pH <7,30)
  6. The attending pediatric intensive care physician believes that the patient is likely to require endotracheal intubation (ETI).

Exclusion Criteria:

  1. Patients younger than 1 month or older than 18 year
  2. Severe ARF defined as Modified Silverman-Wood Downes test >9.
  3. Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion
  4. Facial trauma/burns
  5. Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding
  6. Fixed obstruction of the upper airway.
  7. Inability to protect airway
  8. Life threatening hypoxemia defined as SpaO2 <90% with FiO2 > 0.8 on hi-flow oxygen.
  9. Hemodynamic instability: refractory at volume expansion >60 ml/kg and dopamine >10 mcg/kg/min
  10. Impaired consciousness defined as Glasgow coma scale < 10.
  11. Bowel obstruction.
  12. Untreated pneumothorax.
  13. Poor short term prognosis (high risk of death in the next 3 months)
  14. Known esophageal problem (hiatal hernia, esophageal varicosities)
  15. Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a NG tube.
  16. Neuromuscular disease
  17. Vomiting
  18. Cough or gag reflex impairment.

18. Cyanotic congenital heart disease. 19. Complete absence of cooperation 20. This patient has previously been randomized in the study. 21. Repeated extubation failures (>or= 2).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01873521
Other Study ID Numbers  ICMJE HULP-PI-3751
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ignacio Galicia, Hospital Universitario La Paz
Study Sponsor  ICMJE Hospital Universitario La Paz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert M Kacmarek, PhD RRT FCCM Massachusetts General Hospital, Boston, USA
Principal Investigator: Jesús Villar, MD,PhD Hospital Universitario Dr. Negrin
PRS Account Hospital Universitario La Paz
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP