Comparison Between Rhinopharyngeal Retrograde Clearance and Nasopharyngeal Aspiration in Children With Acute Viral Bronchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Occurrence of wheezing as a measure of respiratory distress
研究概览
简要总结
The purpose of this study is to compare the immediate effects of retrograde rhinopharyngeal clearance with nasopharyngeal aspiration in children admitted with acute viral bronchiolitis. The investigators selected children, up to 12 months old, admitted for acute viral bronchiolitis. Patients were divided in aspiration group (AG), submitted to nasopharyngeal aspiration, and clearance group (CG), submitted to retrograde rhinopharyngeal clearance with physiological solution (0.9%) instillation (RRC) technique. In both groups children were evaluated three times in the same day in order to verify cardiorespiratory parameters, clinical score of respiratory dysfunction and adverse effects.
详细描述
Children up to 12 months old, admitted for acute viral acute viral bronchiolitis were selected. All children participating in the study should be in the first 48 hours of hospitalization. Patients were divided in aspiration group (AG), submitted to nasopharyngeal aspiration, and clearance group (CG), submitted to retrograde rhinopharyngeal clearance (RRC) technique with physiological solution (0.9%) instillation. In both groups children were evaluated three times in the same day (data collection 1 (C1) - performed early in the morning; data collecting 2 (C2) - performed in the early afternoon; and data collecting 3 (C3) - performed in the evening). In each data collection, cardiorespiratory parameters and clinical score of respiratory dysfunction were evaluated before procedures (T0), 10 minutes after (T1) and 30 minutes after (T2). Adverse effects were evaluated during the whole day of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •acute viral bronchiolitis diagnosis
- •indication for hospital admission
排除标准
- •history of lung disease related to prematurity (bronchopulmonary dysplasia)
- •heart diseases
- •chronic lung diseases (cystic fibrosis)
- •pneumonia
- •unstable hemodynamic process (ARDS or sepsis)
- •subcutaneous edema
- •admission to the intensive care unit
- •need for mechanical ventilation or tracheostomy
- •neurological diseases
研究组 & 干预措施
Rhinopharyngeal clearance + 0.9% saline
The retrograde rhinopharyngeal clearance (RRC) is based on the inspiratory reflex that follows a slow and prolonged expiration (passive exhalation technique performed using a slow thoracic-abdominal compression that begins at the end of a spontaneous exhalation and continues until the expiratory reserve volume). At the end of the expiratory time, the child's mouth was closed by the hand of the researcher (raising the lower jaw), leading the child to perform a nasal aspiration maneuver. The instillation of saline (0.9%) preceded this step, resulting in the inhalation of the substance during the forced inspiration, contributing to the nasopharyngeal clearance.
干预措施: Rhinopharyngeal clearance (Procedure)
Rhinopharyngeal clearance + 0.9% saline
The retrograde rhinopharyngeal clearance (RRC) is based on the inspiratory reflex that follows a slow and prolonged expiration (passive exhalation technique performed using a slow thoracic-abdominal compression that begins at the end of a spontaneous exhalation and continues until the expiratory reserve volume). At the end of the expiratory time, the child's mouth was closed by the hand of the researcher (raising the lower jaw), leading the child to perform a nasal aspiration maneuver. The instillation of saline (0.9%) preceded this step, resulting in the inhalation of the substance during the forced inspiration, contributing to the nasopharyngeal clearance.
干预措施: 0.9% saline (Other)
Aspiration + 0.9% saline
Nasopharyngeal aspiration consisted in the introduction of a catheter that, by using negative pressure (vacuum), promotes the suction of secretion from the airways. In order to do that, a sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient. The saline instillation of 0.9% was used for humidification before the procedure.
干预措施: Aspiration (Procedure)
Aspiration + 0.9% saline
Nasopharyngeal aspiration consisted in the introduction of a catheter that, by using negative pressure (vacuum), promotes the suction of secretion from the airways. In order to do that, a sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient. The saline instillation of 0.9% was used for humidification before the procedure.
干预措施: 0.9% saline (Other)
结局指标
主要结局
Occurrence of wheezing as a measure of respiratory distress
时间窗: 30 minutes
Number of vomit episodes as a measure of adverse effects
时间窗: 1 day
Number of nasal bleeding events as a measure of adverse effects
时间窗: 1 day
Occurrence of chest retractions as a measure of respiratory distress
时间窗: 30 minutes
次要结局
- Severity scores on the Wood clinical score(30 minutes)
- Measurement of the heart rate using an oximeter(30 minutes)
- Measurement of the respiratory rate(30 minutes)
- Measurement of the oxygen saturation using an oximeter(30 minutes)
研究者
Marcio Vinicius Fagundes Donadio
Professor
Pontificia Universidade Católica do Rio Grande do Sul