Abstract
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 (PaO 2 ) to fraction of inspired oxygen (FiO 2 ) ratio (PaO 2 /FiO 2 ) 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, PaO 2 /FiO 2 , 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.
Keywords: Cardiac surgery; Paediatric cardiac surgery; Paediatric intensive & critical care; Protocols & guidelines.
【저자키워드】 Critical care, protocols &, guidelines., Cardiac surgery, Paediatric cardiac surgery, Paediatric intensive &, 【초록키워드】 clinical trial, Respiratory failure, Mortality, Trial, intensive care, acute respiratory distress syndrome, mechanical ventilation, Ethics, intensive care unit, oxygen, arrhythmia, China, Hypotension, Patient, Compliance, non-invasive ventilation, Ventilator-free days, Respiratory system, university, Intensive, Critical, acute respiratory distress, primary endpoint, cardiac, protocols, Oxygenation, Hospital stay, barotrauma, respiratory distress, registration number, Serious Adverse Events, Serious Adverse Event, secondary endpoint, lung recruitment, Secondary endpoints, pulmonary complications, syndrome, ethics committee, approval, fraction, West, article, conferences, hypoxaemic respiratory failure, paediatric patients, decrease, Randomly, arterial oxygen tension, IMPROVE, Occurrence, determine, postoperative, reduce, peer-reviewed, after cardiac surgery, paediatric patient, PaO, 【제목키워드】 randomised controlled trial, protocol, after cardiac surgery, paediatric patient,