NCT01873261

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

Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support in Pediatric Acute Respiratory Failure - Pilot Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Failure

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-06-10
• Last updated: 2013-06-10

Locations

1 site across 1 country: Spain