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NCT00893087 Clinical Trial

Comparison of Pressure-, Flow- and Neurally Adjusted Ventilatory Assistance (NAVA)-Triggering in Pediatric and Neonatal Ventilatory Care

Respiration Clinical Trial

Official title:
Comparison of Pressure-, Flow- and NAVA-triggering in Pediatric and Neonatal Ventilatory Care

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00893087
Other study ID # EETTMK:122/2008
Secondary ID
Status Completed
Phase N/A
First received May 3, 2009
Last updated January 19, 2010
Start date February 2009
Est. completion date August 2009

Study information
Verified date January 2010
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines AgencyFinland: Ministry of Social Affairs and HealthEuropean Union: European Medicines Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to study whether neurally adjusted ventilatory assist (NAVA) provides advantages over current methods in detecting patients own breathing efforts in pediatric and neonatal ventilatory care.

Our study hypothesis is that NAVA-technology is more accurate than currently used methods in detecting and assisting spontaneous breathing in children, and thus the patient-ventilator synchrony will improve.

Description:

Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications, make the weaning more difficult and may affect the survival rates.

In this study we will compare two currently used methods pressure- and flow-triggering with a neurally adjusted ventilatory assist in synchronization of the ventilator support with patients own efforts.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date August 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group N/A to 17 Years
Eligibility Inclusion Criteria:

- All children born over 30 weeks of gestation needing ventilatory care

Exclusion Criteria:

- Craniofacial malformation which does not allow feeding tobe positioning. Critical ventilatory or perfusion problems.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Triggering mode of the ventilator
10 min of each triggering mode
• Triggering method of the ventilator
Flow triggering
• Triggering method of the ventilator
Pressure triggering
• Triggering method of the ventilator
NAVA triggering

Locations
Country Name City State
Finland University Hospital of Oulu Oulu

Sponsors (2)
Lead Sponsor Collaborator
University of Oulu University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary The time in ventilator-patient synchrony in each of the assist modes. 30 min No
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