NCT00893087

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

Enrollment Period

5 months

First QC Date

May 3, 2009

Last Update Submit

January 19, 2010

Conditions

Respiration

Keywords

Ventilatory care, children, intensive care, asynchrony, triggeringChildren needing ventilatory care

Outcome Measures

Primary Outcomes (1)

  • The time in ventilator-patient synchrony in each of the assist modes.

    30 min

Study Arms (3)

1

ACTIVE COMPARATOR

Flow triggering

Device: Triggering mode of the ventilatorDevice: Triggering method of the ventilator

2

ACTIVE COMPARATOR

Pressure triggering

Device: Triggering mode of the ventilatorDevice: Triggering method of the ventilator

3

ACTIVE COMPARATOR

NAVA triggering

Device: Triggering mode of the ventilatorDevice: Triggering method of the ventilator

Interventions

Triggering mode of the ventilatorDEVICE

10 min of each triggering mode

123
Triggering method of the ventilatorDEVICE

Flow triggering

1

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Oulu

Oulu, 90220, Finland

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2009

First Posted

May 5, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

FI(1)