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

January 19, 2010 updated by: University of Oulu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90220
        • University Hospital of Oulu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Flow triggering
Device: Triggering mode of the ventilator
10 min of each triggering mode
Device: Triggering method of the ventilator
Flow triggering
Device: Triggering method of the ventilator
Pressure triggering
Device: Triggering method of the ventilator
NAVA triggering
Active Comparator: 2
Pressure triggering
Device: Triggering mode of the ventilator
10 min of each triggering mode
Device: Triggering method of the ventilator
Flow triggering
Device: Triggering method of the ventilator
Pressure triggering
Device: Triggering method of the ventilator
NAVA triggering
Active Comparator: 3
NAVA triggering
Device: Triggering mode of the ventilator
10 min of each triggering mode
Device: Triggering method of the ventilator
Flow triggering
Device: Triggering method of the ventilator
Pressure triggering
Device: Triggering method of the ventilator
NAVA triggering

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time in ventilator-patient synchrony in each of the assist modes.
Time Frame: 30 min
30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Collaborators

Tampere University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

May 3, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 19, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EETTMK:122/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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