Is a Combined Respiratory Muscle Training Intervention, Incorporating Inspiratory and Expiratory Muscle Training, Feasible in Adult Critical Care Patients? A Single Arm Feasibility Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Recruitment Rate Retention and Adherence Rates
研究概览
简要总结
Background: Respiratory muscle weakness is a recognised consequence of mechanical ventilation in critical care. This weakness can have implications for patients, leading to prolonged mechanical ventilation (MV) and intensive care unit (ICU) length of stay (LOS), with worse mortality and morbidity outcomes. The aim of this trial is to assess the safety and feasibility of a combined respiratory muscle training (RMST) intervention for respiratory muscle strengthening, in adult critical care patients receiving or recently liberated from mechanical ventilation.
Methods: This prospective single-arm feasibility study will be conducted in Tallaght University Hospital (TUH) ICU. Ethical approval will be sought from TUH ethics committee with sponsorship from (RCSI) Royal College of Surgeons Ireland. Informed consent will be sought from all eligible patients. Participants will receive a combined RMST intervention in addition to usual care. The primary feasibility outcomes of recruitment, adherence and retention will be reported. Secondary clinical outcomes of respiratory muscle strength (maximal inspiratory / expiratory pressure) and cough strength (peak cough flow) will be assessed at recruitment and weekly up to week three. Therapist perception of service usability will be assessed using the service usability survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18years,
- •mechanically ventilated for ≥ 24 hours,
- •able to initiate spontaneous breaths on MV,
- •on suitable levels of respiratory support with ≤.6 FiO2, ≤10 PEEP,
- •deemed eligible for MV weaning by ICU consultant or recently extubated (<48 hours),
- •alert and collaborative (RASS -2 to +2).
排除标准
- •patients deemed medically unfit by the ICU physicians
- •pregnant patients or breast feeding patients
- •patients with specific pathologies that may impair respiratory muscle function and response to interventions independent of mechanical ventilation and critical care stay
- •Patient who have undergone surgical intervention / repair of the diaphragm within 6 months of the trial, diaphragm / hemi-diaphragm paralysis,
- •patients unable to consent / collaborate in treatment,
- •patients may also be excluded if the ICU physician deems the short disconnection period from MV is unsuitable,
- •patients for palliative management or unlikely to survive their critical care episode.
研究组 & 干预措施
Single arm feasibility of combined respiratory muscle training
The participants will undergo a combined respiratory muscle training intervention including both inspiratory and expiratory muscle training.
干预措施: Combined respiratory muscle training, incorporating both inspiratory and expiratory muscle training (Other)
结局指标
主要结局
Recruitment Rate Retention and Adherence Rates
时间窗: Up to 2 years
The primary outcome measure for this trial are feasibility outcomes: Recruitment rate will be calculated by dividing the number recruited by total number of eligible patients identified and multiplying by 100.
Retention Rates
时间窗: Up to 2 years
Retention rate will be described as the percentage of patients with follow up data available
Adherence Rates
时间窗: Up to 2 years
Adherence rate will be measured as the number of total treatment sessions divided by the number of potential total sessions, multiplied by 100.
次要结局
- Service Usability Scale.(Up to 2 years)
- Inspiratory Muscle Strength(Up to 2 years)
- Expiratory Muscle Strength(Up to 2 years)
- Cough strength(Up to 2 years)