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临床试验/NCT07170085
NCT07170085招募中不适用

Positioning of Children With Acute Respiratory Insufficiency

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
m-WCAS

研究概览

简要总结

Acute respiratory insufficiency is one of the most common causes of hospitalization and death among young children. It often affects small children who, due to infections with RSV (respiratory syncytial virus), other cold viruses, or bacteria, experience difficulty breathing, rapid breathing, increased heart rate, low oxygen levels in the blood, and reduced appetite. If left untreated, a child can become exhausted, lose consciousness, and ultimately die from the condition. Children with severe acute respiratory insufficiency occupy most of the acute care beds in the pediatric wards of hospitals during the winter months. Some children are treated simply with saline inhalations, nasal saline drops, and suctioning of the nose, but many require respiratory support in the form of Continuous Positive Airway Pressure (CPAP) or high-flow oxygen therapy.

In adults, it has been observed that prone positioning can improve blood oxygenation compared to supine positioning in cases of acute respiratory insufficiency.

The purpose of this study is to investigate whether there are benefits or drawbacks to positioning small children admitted for difficulty breathing due to respiratory infections in a prone position instead of a supine position.

The study will include a total of 40 children with acute airway disease who have been prescribed respiratory support in the form of CPAP or high-flow oxygen. The study will last a total of 2 hours and will not involve any uncomfortable procedures or pose any risks to the child.

The Study Itself:

Once the child has CPAP or high-flow oxygen administered via the nose, the child will be positioned for 1 hour in the prone position and 1 hour in the supine position. The order will be random and determined by lottery. A nurse will record the child's breathing in both the prone and supine positions. After the two hours, the child will be placed in the supine position, which is standard practice in the department. The child will have a pulse oximeter on both during the study and afterwards.

详细描述

The purpose of this study is to investigate whether there are benefits or drawbacks to positioning small children admitted for difficulty breathing due to respiratory infections in a prone position instead of a supine position.

Hypothesis:

Children under 1 year of age with acute respiratory insufficiency undergoing CPAP or High-Flow oxygen therapy will have improved respiratory function when positioned in the prone position compared to the supine position, as assessed by respiratory rate and symptom score.

The study will include a total of 40 children with acute airway disease who have been prescribed respiratory support in the form of CPAP or high-flow oxygen.

. Method: The study is designed as an open-label, randomized crossover study. The intervention involves positioning: 1 hour in the prone position and 1 hour in the supine position while the child receives treatment with CPAP or High-Flow oxygen.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 12 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age 0-12 months
  • •Clinical respiratory infection
  • •Physician-ordered High-Flow oxygen or CPAP
  • •Consent from the legal guardian

排除标准

  • •Significant chronic pulmonary, cardiac, or neurological disorders
  • •Children admitted to intensive care

研究组 & 干预措施

supine-prone

Experimental

first supine position, then prone position

干预措施: positioning (Other)

prone-supine

Experimental

first prone position, then supine position

干预措施: positioning (Other)

结局指标

主要结局

m-WCAS

时间窗: one hour

Modified Wood's Clinical Asthma Score (mWCAS) a combined score of saturation, inspiratory wheezes, expiratory wheezes, retractions, general condition, each scored 1-4, with 1 being the best and 4 being the worst

respiratory rate

时间窗: 1 hour

respiration per minute

m-WCAS

时间窗: one hour

Modified Wood's Clinical Asthma Score (mWCAS) a combined score of saturation, inspiratory wheezes, expiratory wheezes, retractions, general condition, each scored 1-4, with 1 being the best and 4 being the worst

respiratory rate

时间窗: 1 hour

respiration per minute

次要结局

  • pulse(1 hour)
  • apneas(1 hour)
  • apneas(1 hour)
  • pulse(1 hour)
  • saturation(1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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