Influence of Patient Positioning During Nasal Lavage (nasal lavage)
Influence of Patient Positioning During Nasal Lavage in Pediatric Patients: A Randomized Controlled Trial
Acute upper respiratory tract infections are the primary cause of pediatric visits and hospitalizations in young children. Nasal congestion and mucus accumulation often cause discomfort, feeding difficulties, and respiratory distress in infants. Nasal lavage using normal saline solution is widely recommended to clear upper airways; however, there is limited evidence regarding the optimal patient posture during irrigation.
This study aims to determine whether patient position-supine (lying on the back) versus sitting (tilted 10 degrees forward)-improves the effectiveness of nasal cavity clearance in children aged 0 to 2 years.
A randomized, parallel, age-stratified clinical trial will be conducted at Pediatric Emergency Department and in Pediatric Hospitalization at Universitary La Paz hospital. Participants will be pediatric patients with mild-to-moderate upper respiratory symptoms requiring nasal lavage as part of their routine care.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ana Martínez-Serrano, phD pediatric nurse
- 电话号码：+34675115169
- 邮箱：ana.martinez.serrano@salud.madrid.org
学习地点
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Madrid、西班牙
- Universitary La Paz Hospital
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接触：
- Ana Martínez-Serrano
- 电话号码：+34675115169
- 邮箱：ana.martinez.serrano@salud.madrid.org
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Pediatric patients aged 0 to 2 years requiring nasal lavage in emergency or hospitalization settings for symptoms related to upper respiratory tract infections
- Modified TAL score <= 8 points (mild to moderate)
- Stable Pediatric Assessment Triangle (PAT), or if unstable, attributable exclusively to respiratory distress while maintaining adequate coloration and normal appearance
- Informed consent signed by parents
Exclusion Criteria:
- Absolute contraindications for nasal lavage (recent unstabilized nasal fractures, acute traumatic brain injury, swallowing disorders, ineffective cough or inability to cough, severe active nasal hemorrhage, unresolved tympanic membrane perforation, severe craniofacial anomalies)
- Post-operative period following recent nasal surgery (< 6 months since the surgical intervention)
- Chronic respiratory pathologies or chronic congenital pulmonary diseases (such as cystic fibrosis)
- Severe physical limitations preventing the safe adoption of any of the studied postures, or severe alteration of consciousness level/cognitive impairment preventing comprehension of instructions and collaboration.
- Patients who do not fully participate in the intervention.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Group A: Supine Position
Patients placed in supine position with the headboard flat and head turned to the side during normal saline nasal irrigation |
Lying position nasal irrigation |
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实验性的：Group B: Semi-sitting Position
Patients placed in a semi-sitting position, tilted 10 degrees forward and swaddled in a sheet during normal saline nasal irrigation |
Seated nasal irrigation 10 degrees forward |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Effectiveness of nasal cavity cleaning according to the investigator
大体时间：Periprocedural
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Visible expulsion of mucus or normal saline solution through nostril after irrigation |
Periprocedural
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Physiological parameters: Oxygen saturation
大体时间：Periprocedural
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Changes in pulse oximetry oxygen saturation percentage |
Periprocedural
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Clinical severity assessed by the modified TAL score
大体时间：Baseline and immediately after the intervention
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Evaluation of respiratory distress using the validated modified TAL score (ranging from 0 to 12 points) |
Baseline and immediately after the intervention
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Incidence and type of adverse effects
大体时间：Periprocedural
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Occurrence and classification of adverse effects experienced during or immediately after the technique, such as nasal bleeding (epistaxis), transient apnea, cyanosis, vomiting, or coughing. |
Periprocedural
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Physiological parameters: heart rate
大体时间：Baseline and immediately after the intervention
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Changes in patient heart rate |
Baseline and immediately after the intervention
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Physiological parameters: respiratory rate
大体时间：Baseline and immediately after the intervention
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Changes in patient respiratory rate |
Baseline and immediately after the intervention
|
合作者和调查者
出版物和有用的链接
一般刊物
- Schmidt MN, Daugberg R, Nygaard U, Nielsen XC, Chawes B, Rytter MH, Schoos AM. Normal saline for children with bronchiolitis: study protocol for a randomised controlled non-inferiority trial. BMJ Paediatr Open. 2024 Jan 17;8(1):e002273. doi: 10.1136/bmjpo-2023-002273.
- Martinez-Serrano A, Martinez-Campos P, Seijoso-Gonzalez L, Ruiz-Rojo H. Literature review of nasal lavage technique in paediatrics. Enferm Clin (Engl Ed). 2021 May-Jun;31(3):189-194. doi: 10.1016/j.enfcli.2021.01.005. Epub 2021 Feb 23. English, Spanish.
- Cabaillot A, Vorilhon P, Roca M, Boussageon R, Eschalier B, Pereirad B. Saline nasal irrigation for acute upper respiratory tract infections in infants and children: A systematic review and meta-analysis. Paediatr Respir Rev. 2020 Nov;36:151-158. doi: 10.1016/j.prrv.2019.11.003. Epub 2020 Feb 21.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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