Status:
UNKNOWN
NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study
Lead Sponsor:
Hospital Universitario La Paz
Conditions:
Acute Respiratory Failure
Eligibility:
All Genders
1-18 years
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.
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 ...
Eligibility Criteria
Inclusion
- 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
- Patients younger than 1 month or older than 18 year
- 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.
- Cyanotic congenital heart disease.
- Complete absence of cooperation
- This patient has been included (randomized) previously in the study
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01873261
Start Date
March 1 2012
End Date
December 1 2013
Last Update
June 10 2013
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046