Evaluation of the Functional Impact of Adenotonsilectomy in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Forced vital capacity (FVC)
研究概览
简要总结
Spirometric assessment of respiratory function before and after adenotonsillectomy surgery
详细描述
Spirometric assessment of respiratory function before and after adenotonsillectomy surgery Study site at CHUPorto: Department of Otorhinolaryngology at CHUPorto, Portugal.
Study design: Institutional, observational, cohort, prospective. Classification of studies according to the law of clinical investigation (Dec. Law No. 21/2014): Clinical study without intervention. Main objective of the study: To collect a database referring to pediatric patients enrolled for surgery in an outpatient setting, in order to compare vital, spirometric and clinical parameters at two different times: pre and post surgical intervention.
Secondary objectives of the study: Based on validated indices, to assess the impact of surgical intervention on the child's respiratory and cardiovascular system. Participants: Patients undergoing surgery in the field of Pediatric Otorhinolaryngology at CHUPorto, a tertiary referral Hospital in Portugal.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 4-14 years;
- •Patients with surgical indication for any combination of:
- •tonsillectomy
- •adenoidectomy
- •turbinoplasty
- •myringotomy;
- •naive children (not submitted to previous ENT surgery);
- •signature of informed consent by the parent entity.
排除标准
- •Age under 4 years and over 14 years;
- •surgery: myringotomy+TT placement exclusively;
- •associated co-morbidities:
- •asthma/other obstructive lung diseases
- •congenital facial or thoracic dysmorphism
- •neurological disease with cognitive impairment
- •cardiopulmonary disease
- •patients without surgical indication
- •other causes of nasal obstruction (severe septum deviation or polyps).
结局指标
主要结局
Forced vital capacity (FVC)
时间窗: 3 months after surgery
Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery.
forced expiratory flow rate at 75% (F75)
时间窗: 3 months after surgery
Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery.
forced expiratory flow between 25 and 75% of the pulmonary volume (FEF25-75%).
时间窗: 3 months after surgery
Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery.
Forced expiratory volume in the first second (FEV 1)
时间窗: 3 months after surgery
Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery.
Peak expiratory flow (PEF)
时间窗: 3 months after surgery
Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery.
forced expiratory flow rate at 25% (F25)
时间窗: 3 months after surgery
Measured in two moments by the same operator: pre-operatively, in the day of intervention and post-operatively, 3 months after surgery.
次要结局
- Weight(3 months after surgery)
- Diastolic arterial pressure(3 months after surgery)
- Systolic arterial pressure(3 months after surgery)
- Heart rate(3 months after surgery)
- rest oxygen saturation(3 months after surgery)