NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study

• Conditions: Acute Respiratory Failure

• Registration Number: NCT01873261
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-02-19
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-07
• Last Update Submitted: 2013-06-07
• Study First Posted: 2013-06-10
• Last Update Posted: 2013-06-10
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Avoiding endotracheal intubation using non-invasive ventilation	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

Name	Time	Method
Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV	During mechanical ventilation after NIV
Length (days) of PICU stay after NIV	After NIV	The patients will be follow up after NIV during the PICU stay, and average of two weeks
Length (days) hospital stay after NIV	After NIV	The patients will be follow up after NIV during hospital stay, an average of 2-3 weeks.

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain