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

Withdrawn

• Conditions: Innate immuunresponse; lung injury due to mechanical ventilation; Ventilator Induced Lung Injury (VILI); 10024967

• Registration Number: NL-OMON33002
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 36

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.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the effects of low and high VT (ml/kg) HA on<br /><br>hemodynamics and pulmonary gas exchange. </p><br>