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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00521625 |
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Date of registration:
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24/08/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury
PALIVE1 |
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Scientific title:
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Epidemiologic Multicenter Study on Mechanical Ventilation Management in Children With Acute Lung Injury - Phase 1 PALIVE 1 (for Pediatric Acute Lung Injury Mechanical VEntilation Strategies) |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00521625 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Austria
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Belgium
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Canada
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France
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Germany
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Italy
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Netherlands
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Spain
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Sweden
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Philippe 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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Hôpital Ste-Justine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Child on invasive mechanical ventilation administered through an endotracheal
tube or a tracheostomy tube, or on non-invasive mechanical ventilation administered
through a nasal or facial mask or a nasal canula or helmet at 9 a.m. on the day of
the study.
- Presence of ALI as estimated by the attending physician:
1. Onset of hypoxemia was acute
2. Bilateral infiltrates on chest X-Ray
3. No clinical evidence of congestive heart failure
4. Sustained hypoxemia defined as:
PaO2(mmHg)/FiO2 ratio = 300 or PaO2(kPa)/FiO2 = 40
If no arterial canula or no arterial blood gas:
SpO2/FiO2 = 320 with SpO2 < 0.98 (10)
Exclusion Criteria:
- Post conceptional age < 42 weeks
- Age > 18 years
- Non-corrected cyanotic congenital heart disease or evidence of extra-pulmonary right
to left shunt
- Withdrawal/withholding of care
- Brain death
- No consent, if required
- Patient on ECMO
- Already included in this study
Age minimum:
N/A
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Lung Injury
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Acute Respiratory Distress Syndrome
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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