Physiological Effects of Prone vs. sUpine Position on Lung Recruitability in infantS/Children With Acute Respiratory Distress Syndrome

Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 enhances lung recruitment, modifying both lung ventilation (VA) and lung perfusion (Q) distribution, finally generating an improvement in VA/Q matching and reversing oxygenation impairment;it reduces right ventricular afterload, increase cardiac index in subjects with preload reserve and reverse acute cor pulmonale in severe ARDS patients, but in infants and children there is still a lack of clear evidence. Taken together, these effects explain why PP improves oxygenation, limits the occurrence of ventilator-induced lung injury and improves survival. Prone position is simple to perform in infants and in some neonatal and pediatric intensive care units is already commonly accomplished. However, a detailed analysis of the respective effects of high PEEP and prone position is lacking in infants/children with ARDS, while these two tools may interfere and/or act coherently. A recent multicenter, retrospective analysis of patients with pediatric acute respiratory distress syndrome (PARDS) describes how patients managed with lower PEEP relative to FIO2 than recommended by the ARDSNet model had higher mortality, suggesting that future clinical trials targeting PEEP management in PARDS are needed. We designed a physiological study to investigate the physiological effects of prone positioning on lung recruitability in infants/children with acute respiratory distress syndrome.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Giorgio Conti
RECRUITING
Rome
Time Frame
Start Date: 2023-09-01
Completion Date: 2025-09
Participants
Target number of participants: 15
Treatments
Experimental: Controls
Eligible patients will undergo the experimental protocol.
Experimental: Patients
Eligible patients will undergo the experimental protocol.
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov