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Humidified versus nonhumidified low-flow oxygen therapy in children with Pierre-Robin syndrome: Study protocol for a
Zunjia Wen1, Xin Zhang1, Yingfei Liu1
1Children's Hospital of Nanjing Medical University, Nanjing, China.
Insights
This study investigates if humidified oxygen is necessary for children with Pierre-Robin syndrome receiving low-flow oxygen therapy. Findings will clarify best practices for oxygen delivery in this pediatric population.
Area of Science:
- Pediatric respiratory care
- Clinical trial methodology
- Pierre-Robin syndrome management
Background:
- The necessity of humidification during low-flow oxygen therapy in children is not well-established.
- Current literature lacks studies addressing oxygen humidification specifically in pediatric patients.
- Further research is required to clarify optimal oxygen delivery protocols for children.
Purpose of the Study:
- To evaluate the necessity of humidified versus non-humidified oxygen in low-flow oxygen therapy for children with Pierre-Robin syndrome.
- To provide evidence-based guidance on oxygen humidification practices in pediatric respiratory care.
Main Methods:
- A randomized controlled trial (RCT) adhering to SPIRIT guidelines.
- 188 children with Pierre-Robin syndrome will be randomized into two groups: humidified oxygen (n=94) and non-humidified oxygen (n=94).
- Key outcomes include arterial blood gases (PaO2, PaCO2), incidence of ventilator-associated pneumonia (VAP), nasal complications, therapy costs, and ICU stay duration.
Main Results:
- The study is planned to commence in May 2019, with results anticipated by July 2020.
- Data collection will focus on physiological parameters, infectious complications, local tolerance, and resource utilization.
Conclusions:
- This RCT aims to provide robust evidence regarding the necessity of routine oxygen humidification in low-flow oxygen delivery for pediatric patients.
- Findings will inform clinical practice and improve nursing care for children requiring oxygen therapy.
Aims And Objectives:
To evaluate the necessity of oxygen humidification for low-flow oxygen therapy in children with Pierre-Robin syndrome.
Background:
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.
Design:
A randomised controlled trial.
Methods:
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.
Results:
The study is planned to start in May 2019, and the results will be expected in July 2020.
Conclusions:
This study is expected to provide a credible evidence on the necessity of routine oxygen humidification in low-flow oxygen delivery.
Relevance To Clinical Practice:
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.
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