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NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study (NINAVAPed)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01873261
Recruitment Status : Unknown
Verified June 2013 by Ignacio Galicia, Hospital Universitario La Paz.
Recruitment status was:  Recruiting
First Posted : June 10, 2013
Last Update Posted : June 10, 2013
Information provided by (Responsible Party):
Ignacio Galicia, Hospital Universitario La Paz

Brief Summary:
This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.

Condition or disease
Acute Respiratory Failure

Detailed Description:

This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.

Every PICU will have to include 3 patients in the Pilot study before starting the clinical trial, which means that the pilot study will involve a maximum of 60 patients.

Should the Pilot study reveal deficiencies in the NiNAVAped design, the protocol would be improved accordingly.

There will be a specific consent document during the Pilot study. The Pilot study will be published in a scientific journal.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support in Pediatric Acute Respiratory Failure - Pilot Study
Study Start Date : March 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Primary Outcome Measures :
  1. Avoiding endotracheal intubation using non-invasive ventilation [ Time Frame: During non invasive ventilation, an average of 2-3 days. ]
    The primary endpoint of this study is avoiding endotracheal intubation (ETI) (and conventional mechanical ventilation (MV)) using non-invasive ventilation (NIV). It is defined as no need for ETI (and MV) for at least 48h after the withdrawal of NIV.

Secondary Outcome Measures :
  1. Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV [ Time Frame: During mechanical ventilation after NIV ]
  2. Length (days) of PICU stay after NIV [ Time Frame: After NIV ]
    The patients will be follow up after NIV during the PICU stay, and average of two weeks

  3. Length (days) hospital stay after NIV [ Time Frame: After NIV ]
    The patients will be follow up after NIV during hospital stay, an average of 2-3 weeks.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children from 1 month to 18 years admitted to the PICU with moderate/severe acute respiratory failure minimally sedated/agitated

Inclusion Criteria:

  • Age: > 1 month age to 18 years
  • Moderate/severe Pediatric Acute Respiratory failure of any origin evaluated after a period of respiratory stabilization (aspiration of secretions, physiotherapy, oxygen and nebulized therapy) when the attending pediatric intensive care physician believes that the patient is likely to require endotracheal intubation (ETI).
  • Non intubated
  • Admitted to the PICU
  • Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01873261

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Contact: Pedro De la Oliva, MD, PhD +347277149

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Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Pedro De la Oliva, MD,PhD    0034917277149   
Principal Investigator: Pedro De la Oliva, MD, PhD         
Sponsors and Collaborators
Hospital Universitario La Paz
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Study Director: Robert M Kacmarek, PhD RRT FCCM Massachusetts General Hospital, Boston, USA
Principal Investigator: Jesús Villar, MD, PhD Hospital Universitario Dr. Negrin

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Responsible Party: Ignacio Galicia, Dr, Hospital Universitario La Paz Identifier: NCT01873261    
Other Study ID Numbers: HULP-PI-3750
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: June 2013
Keywords provided by Ignacio Galicia, Hospital Universitario La Paz:
Neurally Adjusted Ventilatory Assist
Pediatric Acute Respiratory Failure
non-invasive ventilation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases