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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 with or without acute lung injury. - Mechanical ventilation comparing high versus low tidal volumes in infants.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33002
Enrollment
36
Registered
2009-03-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Innate immuunresponse lung injury due to mechanical ventilation Ventilator Induced Lung Injury (VILI)

Interventions

After inclusion patients will be ventilated for a period of 6 hours with a PEEP of 7 cm H2O and VT of 8 ml/kg predicted body weight (*wash in period*). Following these 6 hours patients will be rando

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion 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

Exclusion criteria: • No informed consent from the patient*s legal representative • Expected survival 2 years • Use of corticosteroids 0.5 microgram/kg/min in spite of adequate fluid resuscitation • Pneumothorax proven by chest X-ray. • Severe chest deformations (open sternum, flial chest, kyphoscoliosis) • Chronic hypoxemic lung disease • Cyanotic congenital heart disease • Cardiac failure as a primary cause of lung disease • Patients who had received a bone marrow or lung transplantation • Patients with increased intracranial pressure • Patients who had participated in other clinical trials involving acute lung injury within the preceding 30 days. • Severe chronic liver disease (as defined by Child-Pugh class C) • Patients after cardiac resuscitation • Patients with a decision to limit life support.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the effect of low and high VT (ml/kg) on pulmonary and systemic inflammatory responses and the release of oxygen and nitrogen free radicals determined in deep tracheal aspirate and in plasma respectively, in the paediatric patient with and without ALI.

Secondary

MeasureTime frame
Secondary endpoints are the effects of low and high VT (ml/kg) HA on hemodynamics and pulmonary gas exchange.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)