A Pilot, Non-randomized, Single-site Clinical Study Investigating the Efficacy of Combined Therapy of Nebulized 3% Hypertonic Saline and Chest Percussion Therapy in Pediatric Patients With Acute Viral Bronchiolitis.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Time on Supplemental Oxygen Support
研究概览
简要总结
This study will examine the efficacy of combined nebulized hypertonic saline with chest percussion therapy in patients age 0 to 24 months admitted to the general inpatient pediatrics unit with acute bronchiolitis. 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy will be administered every 6 hours of patients selected for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study (experimental arm), an individual must meet all of the following criteria:
- •Age 0 to 24 months
- •Admitted to the general inpatient pediatrics unit
- •Has a diagnosis of acute bronchiolitis
- •Receiving supplemental oxygen support
- •Data collected for the control arm will be obtained via retrospective chart review for patients meeting the following inclusion criteria:
- •Age 0 to 24 months
- •Admitted to the general inpatient pediatrics unit
- •Has a diagnosis of acute bronchiolitis
- •Receiving supplemental oxygen support
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Admitted to the pediatric intensive care unit
- •Has an underlying pre-existing condition that may affect the respiratory system (includes bronchopulmonary dysplasia, reactive airways disease, asthma, restrictive lung diseases, other chronic lung diseases, etc.)
- •Has other comorbid conditions upon admission that may affect the respiratory system (includes pneumonia or other bacterial or fungal lung infections, acute exacerbation of reactive airways disease, acute exacerbation of asthma, pulmonary edema, pleural effusion, etc.)
- •Has an absolute contraindication to nebulized 3% hypertonic saline, for example, a history of an allergic or anaphylactic reaction
- •Is receiving other respiratory treatments such as bronchodilator treatments (i.e. albuterol or levalbuterol)
- •Is receiving other adjuvant therapy such as antibiotics, antivirals, glucocorticoids, corticosteroids, or diuretics
- •A potential study subject in the control arm via retrospective chart review who meets any of the following criteria will be excluded from this study:
- •Admitted to the pediatric intensive care unit
- •Has an underlying pre-existing condition that may affect the respiratory system (includes bronchopulmonary dysplasia, reactive airways disease, asthma, restrictive lung diseases, other chronic lung diseases, etc.)
- •Has other comorbid conditions upon admission that may affect the respiratory system (includes pneumonia or other bacterial or fungal lung infections, acute exacerbation of reactive airways disease, acute exacerbation of asthma, pulmonary edema, pleural effusion, etc.)
- •Has an absolute contraindication to nebulized 3% hypertonic saline, for example, a history of an allergic or anaphylactic reaction
- •Is receiving other respiratory treatments such as bronchodilator treatments (i.e. albuterol or levalbuterol)
- •Is receiving other adjuvant therapy such as antibiotics, antivirals, glucocorticoids, corticosteroids, or diuretics
研究组 & 干预措施
Nebulized Hypertonic Saline + Chest Percussion Therapy
Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours.
干预措施: Nebulized 3% sodium chloride solution (Drug)
Nebulized Hypertonic Saline + Chest Percussion Therapy
Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours.
干预措施: Chest percussion cups (Device)
Control Arm
Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial.
结局指标
主要结局
Time on Supplemental Oxygen Support
时间窗: Up to time of discharge (Approximately 1-5 days on average)
Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit.
Length of Hospital Stay
时间窗: Up to time of discharge (Approximately 1-5 days on average)
Measured in days from from time of admission to the general inpatient pediatrics unit until time of discharge from the general inpatient pediatrics unit.
次要结局
- Average Pulse Oximetry Reading(Up to time of discharge (Approximately 1-5 days on average))
- Average Heart Rate(Up to time of discharge (Approximately 1-5 days on average))
- Average Respiratory Rate(Up to time of discharge (Approximately 1-5 days on average))
- Number of Caregivers Who Rate Child's Response as "Improved"(Time of discharge (Approximately 1-5 days on average))
- Number of Physicians Who Rate Child's Response as "Improved"(Time of discharge (Approximately 1-5 days on average))