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Updated: Sep 23, 2025
Ex Vivo Porcine Experimental Model for Studying and Teaching Lung Mechanics
Published on: April 19, 2024
Study protocol for a single-centre randomised controlled trial to investigate the effect of lung recruitment in
Miaomiao Gu1, Ni Deng1, Wenxi Xia2
1Department of Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China.
Insights
Lung recruitment may reduce mechanical ventilation duration in pediatric cardiac surgery patients with hypoxemic respiratory failure. This trial investigates its effectiveness in improving outcomes for this vulnerable population.
Area of Science:
- Pediatric Critical Care Medicine
- Respiratory Physiology
- Cardiothoracic Surgery
Background:
- Lung recruitment strategies improve oxygenation and reduce mechanical ventilation (MV) duration in adults with acute hypoxemic respiratory failure.
- Evidence for lung recruitment in pediatric patients, particularly post-cardiac surgery, is limited.
- Acute hypoxemic respiratory failure is a significant concern in pediatric patients following cardiac surgery.
Purpose of the Study:
- To determine if lung recruitment reduces the duration of mechanical ventilation in pediatric patients with hypoxemic respiratory failure after cardiac surgery.
- To evaluate the impact of lung recruitment on secondary outcomes including ventilator-free days and length of stay.
- To assess the safety and efficacy of lung recruitment in this specific pediatric population.
Main Methods:
- A randomized clinical trial involving 234 pediatric patients (28 days to 14 years) within 72 hours post-cardiac surgery.
- Patients with an arterial oxygen tension to fraction of inspired oxygen ratio (PaO2/FiO2) <300 were randomized to either a lung recruitment group or a conventional care group.
- Primary endpoint: duration of mechanical ventilation. Secondary endpoints: ventilator-free days, PaO2/FiO2, respiratory system compliance, and adverse events.
Main Results:
- This section is to be filled once the study results are available.
- The study is designed to provide data on the primary and secondary endpoints.
- Analysis will focus on comparing outcomes between the lung recruitment and conventional groups.
Conclusions:
- This clinical trial will provide crucial evidence on the efficacy of lung recruitment in pediatric cardiac surgery patients.
- Findings will inform clinical practice guidelines for managing hypoxemic respiratory failure in this population.
- The study aims to improve ventilation strategies and patient outcomes post-pediatric cardiac surgery.
Introduction:
A number of published studies have revealed that lung recruitment can improve oxygenation, shorten the duration of mechanical ventilation (MV) and decrease mortality in adults with acute hypoxaemic respiratory failure, especially patients with acute respiratory distress syndrome. However, few articles have assessed lung recruitment in paediatric patients, especially after cardiac surgery. This clinical trial aimed to determine whether lung recruitment can reduce the duration of MV in paediatric patients with hypoxaemic respiratory failure after cardiac surgery.
Method And Analysis:
In this trial, we will randomly assign 234 paediatric patients (aged 28 days to 14 years) within 72 hours after cardiac surgery with an arterial oxygen tension (PaO2) to fraction of inspired oxygen (FiO2) ratio (PaO2/FiO2) of <300 to either a lung recruitment group or a conventional group. The primary endpoint will be the duration of MV. The secondary endpoints will be ventilator-free days, PaO2/FiO2, respiratory system compliance, duration of non-invasive ventilation, reintubation rate, length of intensive care unit stay, length of hospital stay, occurrence of serious adverse events (barotrauma, persistent hypotension and arrhythmia), postoperative pulmonary complications.
Ethics And Dissemination:
The ethics committee of West China Hospital of Sichuan University granted ethics approval for this study (20 August 2019). The results will be published in peer-reviewed journals and presented at conferences.
Trial Registration Number:
ChiCTR1900025990.
