NL-OMON33002
Withdrawn
Not Applicable
Mechanical ventilation comparing high versus low tidal volumes in infants with or without acute lung injury. - Mechanical ventilation comparing high versus low tidal volumes in infants.
niversitair Medisch Centrum Sint Radboud0 sites36 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Innate immuunresponse
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 36
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Children between the age of 2 months and 2 years admitted to the PICU and requiring MV with ALI and non ALI.
- •ALI is defined as:
- •\- Bilateral infiltration seen on frontal chest radiograph
- •\- No clinical evidence of left atrial hypertension
- •\- Partial pressure of oxygen (PaO2\)/fraction of inspired oxygen (FiO2\) ratio of less than 300 mmHg
- •2\. Patients on ventilatory support not exceeding 72 hours before inclusion of the study.
- •3\. The expected duration of ventilation should be minimal 24 hours.
- •4\. Patients should be ventilated by the Pressure Regulated Volume Controle (PRVC) mode.
Exclusion Criteria
- •No informed consent from the patient\*s legal representative
- •Expected survival \< 2 days
- •Infants \< 2 months of age and infants \> 2 years
- •Use of corticosteroids \< 6 weeks before the start or during the study
- •Immunocompromised patients
- •Critical pulmonary or cardiac function documented by an FiO2/PaO2 ratio
- •\< 100 mmHg or need of catecholamines for inotropic support
- •defined as norepinephrine \> 0\.5 microgram/kg/min in spite of adequate fluid
- •resuscitation
- •Pneumothorax proven by chest X\-ray.
Outcomes
Primary Outcomes
Not specified
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