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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00603174 |
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Date of registration:
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21/11/2007 |
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Primary sponsor: |
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Public title:
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Use of Neurally Adjusted Ventilatory Assist in Infants Respiratory Failure
NAVA |
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Scientific title:
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Use of Neurally Adjusted Ventilatory Assist in Infants With Acute Respiratory Failure: a Case Study on Servo I |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00603174 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Jennifer Beck, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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SunnyBrook Health Sciences Centre - Toronto |
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Name:
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Philippe A Jouvet, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Université de Montréal |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Intubated and mechanically ventilated infant with respiratory failure < 1 year old)
- Breathing spontaneously, as defined by the ability to trigger the ventilator
- The infant should be breathing on conventional ventilation (SIMV, assist control, or
pressure support) with the following ventilator parameters: pressure plateau < 22 cm
H2O (above PEEP) and PEEP = 6 cm H2O.
Exclusion Criteria:
- Pneumothorax
- Degenerative neuromuscular disease
- Bleeding disorders
- Cardiovascular instability defined by vasopressors infusion (dopamine = 5µg/kg/min,
epinephrine, norepinephrine, dobutamine, vasopressin)
- Cyanotic congenital cardiovascular disease
- Phrenic nerve damage/diaphragm paralysis
- Esophageal perforation
- Use of high frequency oscillatory or jet ventilation
- Contraindication to changing naso gastric tube
- Infant is deemed "too unstable" by the attending physician
Age minimum:
N/A
Age maximum:
12 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Respiratory Failure
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Intervention(s)
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Device: neurally adjusted ventilatory assist (NAVA)
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Primary Outcome(s)
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patient-ventilator synchrony
[Time Frame: up to 28 days]
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Secondary Outcome(s)
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Number of PEEP or NAVA level adjustments in NAVA mode
[Time Frame: up to 28 days]
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Number of times back-up rate started (per hour) in NAVA mode
[Time Frame: up to 28 days]
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Phasic EAdi • Tonic EAdi Phasic EAdi and tonic EAdi
[Time Frame: up to 28 days]
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Tolerance
[Time Frame: up to 28 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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