Humidified versus nonhumidified low-flow oxygen therapy in children with Pierre-Robin syndrome: Study protocol for a randomised controlled trial.

Abstract

To evaluate the necessity of oxygen humidification for low-flow oxygen therapy in children with Pierre-Robin syndrome. Whether to carry out humidification or not in the low-flow oxygen delivery remains unclear, and currently, there is no published study on this issue in the population of children. Therefore, it is necessary to conduct more studies to elucidate this issue. A randomised controlled trial. We attempt to report this randomised controlled trial to comply with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). 188 children with Pierre-Robin syndrome will be expected to inclusion. The participants will be randomly divided into the humidified group (n=94) and nonhumidified group (n=94) at a ratio of 1:1. For humidified group, the oxygen will be routinely humidified with disposable bottle containing sterile water, whereas for nonhumidified group, the oxygen will not be humidified. Average arterial oxygen partial pressure (PaO2 ) and carbon dioxide partial pressure (PaCO2 ), incidence of ventilator-associated pneumonia (VAP), nasal cavity dryness, nasal mucosal bleeding and bacterial contamination of the humidified bottle, the cost of nasal oxygen therapy and duration of ICU stay are collected and analysed. The study is planned to start in May 2019, and the results will be expected in July 2020. This study is expected to provide a credible evidence on the necessity of routine oxygen humidification in low-flow oxygen delivery. Understanding the role of oxygen humidification and no humidification for low-flow oxygen therapy in the population of children is beneficial to the nursing care of healthcare providers in clinical setting.