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The present study is a pilot prospective safety evaluation of a new closed loop computerised protocol on ventilation and oxygenation in stable, spontaneously breathing children weighing more than 7 kg, during the weaning phase of mechanical ventilation.    Methods  Mechanically ventilated children ready to start the weaning process were ventilated for five periods of 60 minutes in the following order: pressure support ventilation, adaptive support ventilation (ASV), ASV plus a ventilation controller (ASV-CO 2 ), ASV-CO 2  plus an oxygenation controller (ASV-CO 2 -O 2 ) and pressure support ventilation again. Based on breath-by-breath analysis, the percentage of time with normal ventilation as defined by a respiratory rate between 10 and 40 breaths/minute, tidal volume > 5 ml/kg predicted body weight and end-tidal CO 2  between 25 and 55 mmHg was determined. The number of manipulations and changes on the ventilator were also recorded.    Results  Fifteen children, median aged 45 months, were investigated. No adverse event and no premature protocol termination were reported. ASV-CO 2  and ASV-CO 2 -O 2  kept the patients within normal ventilation for, respectively, 94% (91 to 96%) and 94% (87 to 96%) of the time. The tidal volume, respiratory rate, peak inspiratory airway pressure and minute ventilation were equivalent for all modalities, although there were more automatic setting changes in ASV-CO 2  and ASV-CO 2 -O 2 . Positive end-expiratory pressure modifications by ASV-CO 2 -O 2  require further investigation.    Conclusion  Over the short study period and in this specific population, ASV-CO 2  and ASV-CO 2 -O 2  were safe and kept the patient under normal ventilation most of the time. Further research is needed, especially for positive end-expiratory pressure modifications by ASV-CO 2 -O 2 .    Trial registration  ClinicalTrials.gov:  NCT01095406

A pilot prospective study on closed loop controlled ventilation and oxygenation in ventilated children during the weaning phase