Prone Position in infantS/Children With Acute Respiratory Distress Syndrome

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.

Conditions

• Prone Position
• Acute Respiratory Distress Syndrome

Interventions

PROCEDURE

supine position

At the end of the PEEP trial (i.e. at PEEP 5 cmH2O), patients will lay in the supine position for 15 minutes arterial blood gases will be performed and then a one-breath derecruitment maneuver (5-second exhalation, respiratory rate \< 8 bpm) from PEEP 5 cmH2O to 0 cmH2O will be conducted to assess baseline functional residual capacity (FRC), defined as the EELI measured at 0 PEEP.

PROCEDURE

prone position

After the supine step, each enrolled patient will be placed in the prone position for 1 hour. For safety reasons, enteral feeding will be interrupted 30 minutes before prone positioning and re-established after the study ending. During pronation FiO2 will be increased up to 80% and then gradually decreased to the baseline value within the first 30 minutes of prone positioning. After 30 minutes of PEEP 12 cmH2O (provided that plateau and driving pressures did not exceed 30 cmH2O and 15 cmH2O, respectively) to stabilize lung volumes, the same measurements applied for the supine step will be performed. Any further modifications in the MV settings will be discouraged over the entire course of the study; nonetheless, if needed to achieve the SpO2 target, an increase in FiO2 will be allowed and recorded. In case of sudden worsening of the oxygenation impairment or haemodynamic, 100% FiO2 will be set, and the patient will be promptly positioned in the supine semi-recumbent position.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-01

Primary Completion

2024-09-30

Completion

2025-09-30

Countries

• Italy

Study Locations