Status:
UNKNOWN
Prone Position in infantS/Children With Acute Respiratory Distress Syndrome
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Prone Position
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
In adult patients with acute respiratory distress syndrome (ARDS), the beneficial effects of prone position (PP) have been well investigated and explored; it reduces intrapulmonary shunt (Qs/Qt) and e...
Detailed Description
Each patient meeting inclusion criteria will be evaluated for the presence of the oxygenation criterion. After neuromuscular paralysis (or apnoeic ventilation as per PICU protocol), and endotracheal s...
Eligibility Criteria
Inclusion
- PaO2/FiO2 \< 200 in the supine position, with a standard PEEP of 5 cmH2O;
- PaCO2 \<45mmHg;
- Absence of history of chronic respiratory disease or heart failure or congenital heart disease (Modified Ross heart failure classification for children \< II);
- Not underweight infants/children defined as a low body mass index (BMI) for age;
- Absence of any contraindication to PP (Appendix 1);
- Written informed consent of both parents and the legal guardian.
Exclusion
- Barotrauma;
- Less than 4 weeks of age (new-born physiology);
- Exacerbation of asthma;
- Chest trauma;
- Pulmonary oedema/haemorrhage;
- Severe Neutropenia (\<500 WBC/mm3);
- Haemodynamic instability (Systolic blood pressure \< 5th percentile or mean arterial pressure \< 5th percentile adjusted by age);
- Lactic acidosis (lactate \>5 mmol/L) and/or clinically diagnosed shock;
- Metabolic Acidosis (pH \<7.30 with normal- or hypo-carbia);
- Chronic kidney failure requiring dialysis before PICU admission;
- Upper gastrointestinal bleeding.
- Refusal to sign written informed consent of both parents and the legal guardian.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06020404
Start Date
September 1 2023
End Date
September 1 2025
Last Update
February 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Giorgio Conti
Rome, Italy, 00168