Status:
UNKNOWN
Neurally Adjusted Ventilatory Assist (NAVA) vs. Pressure Support in Pediatric Acute Respiratory Failure
Lead Sponsor:
Hospital Universitario La Paz
Conditions:
Pediatric Acute Respiratory Failure
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
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 ch...
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 Pedi...
Eligibility Criteria
Inclusion
- Age \> 1 month age or weight \> 3 Kg to 18 years
- Not intubated.
- Admitted to the PICU.
- Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2).
- 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)
- The attending pediatric intensive care physician believes that the patient is likely to require endotracheal intubation (ETI).
Exclusion
- Patients younger than 1 month or older than 18 year
- Severe ARF defined as Modified Silverman-Wood Downes test \>9.
- Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion
- Facial trauma/burns
- Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding
- Fixed obstruction of the upper airway.
- Inability to protect airway
- Life threatening hypoxemia defined as SpaO2 \<90% with FiO2 \> 0.8 on hi-flow oxygen.
- Hemodynamic instability: refractory at volume expansion \>60 ml/kg and dopamine \>10 mcg/kg/min
- Impaired consciousness defined as Glasgow coma scale \< 10.
- Bowel obstruction.
- Untreated pneumothorax.
- Poor short term prognosis (high risk of death in the next 3 months)
- Known esophageal problem (hiatal hernia, esophageal varicosities)
- Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a NG tube.
- Neuromuscular disease
- Vomiting
- 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).
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01873521
Start Date
February 1 2014
End Date
December 1 2016
Last Update
April 16 2014
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046