Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities: A Multicenter Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Number of readmissions with respiratory decompensation
研究概览
简要总结
Chronic respiratory failure is the leading cause of morbidity and mortality in children with multiple disabilities. Musculoskeletal disorders, swallowing disorders and ventilatory control abnormalities lead to progressive respiratory impairment, causing episodes of respiratory decompensation (RD). These are the leading cause of mortality (50 to 80%, average age of death: 21 years) and the cause of repeated hospitalizations.
Respiratory care for these children is therefore a major challenge. In respiratory physiotherapy, this can be achieved through manual techniques and/or instrumental techniques such as intrapulmonary percussive ventilation (IPV), which is particularly useful in this population because it does not require active cooperation.
The main objective of this study is to evaluate, in children with multiple disabilities, the effectiveness at 18 months of using an IPV at home and by carers, combined with standard respiratory physiotherapy, compared with manual respiratory physiotherapy alone.This is a multicenter, randomized controlled superiority trial with two parallel groups.
All centers will recruit children aged 1 to 16 with multiple disabilities, during hospitalization with respiratory decompensation (RD). After consent has been signed by the parents or legal guardians, the patient will be randomized into one of the two study groups:
- Control group: manual respiratory physiotherapy.
- Intervention group: intrapulmonary Percussive Ventilation (IPV)
详细描述
IPV is used in France in different ways, depending on the center and service practices, as a complement to manual techniques.
At Armand Trousseau University Hospital, our experience over the past five years with more than 50 children suggests that the use of IPV by carers in their home environment. This is done as a complement to private manual physiotherapy sessions after training by a professional.
However, the benefits and impact of IPV on patients' respiratory development remain largely unstudied, particularly in patients with multiple disabilities. This multicenter randomized controlled study could provide recommendations for the respiratory management of these patients.
The main objective of this study is to evaluate, in children with multiple disabilities, the effectiveness at 18 months of using an IPV in the home and by carers, combined with standard respiratory physiotherapy, compared with manual respiratory physiotherapy alone. The primary endpoint is the number of rehospitalizations for RD at 18 months following the index hospitalization.
All centers will recruit children aged 1 to 16 with multiple disabilities, during hospitalization with Respiratory Decompensation (RD). the patient will be randomized into one of the two study groups:
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
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polyhandicap defined by:
- •Causal brain injury or lesion occurring before the age of 3 years,
- •Severe or profound intellectual disability according to DSM IV definition
- •Motor disability: paraplegia/quadriplegia, hemiparesis, ataxia, and/or extrapyramidal motor disorders,
- •Gross Motor Function Classification System (GMFCS) score of IV or V,
- •Functional Independence Measure (FIM) score < 55,
- •Age: 1 to 16 years,
- •Hospitalization of the patient with respiratory decompensation (RD),
- •Informed consent from parents/legal guardians
排除标准
- •Associated neuromuscular disease
- •Daily use of intrapulmonary percussive ventilation for more than 3 consecutive months within the 6 months prior to inclusion,
- •Daily use of a cough assistance device such as an insufflator-exsufflator for more than 3 consecutive months within the 6 months prior to inclusion,
- •Contraindications for the use of the medical device:
- •Pneumothorax,
- •Hypotension or hemodynamic instability,
- •Hemoptysis,
- •Participation in another interventional study.
- •Patients with tracheobronchial collapse during expiration
研究组 & 干预措施
IPV + Manual Respiratory Physiotherapy
After the device has been adjusted to suit the child and carers have been trained during hospitalisation, IPV will be prescribed for use by carers at home for 15 minutes, five times a week, in addition to manual RP prescribed 2 to 3 times a week in private practice or at home.
干预措施: Intrapulmonary Percussive Ventilation IPV (Procedure)
Manual Respiratory Physiotherapy Only
no intervention, current practice
结局指标
主要结局
Number of readmissions with respiratory decompensation
时间窗: 18 months after the index hospitalization with respiratory decompensation
次要结局
- Number of days of hospitalization(18 months after the index hospitalization with respiratory decompensation.)
- Number and duration of respiratory exacerbations managed at home, emergency visits not followed by hospitalizations and unscheduled consultations(18 months after the index hospitalization with respiratory decompensation.)
- Number of days on antibiotics for respiratory issues(18 months after the index hospitalization with respiratory decompensation.)
- PolyQol scale(At month 1, month 3, month 6, month 12, and month 18)
- PERKINE Questionnaire(At month 1, month 3, month 6, month 12, and month 18)
- Cost-Effectiveness Analysis(At the end of the study)