Changes in Functional and Qualitative Indicators of Critically Ill Patients With Respiratory Failure Using Different Physiotherapy Methods
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) from baseline to ICU discharge
研究概览
简要总结
The aim of the biomedical study is to assess the changes in functional and qualitative indicators of critically ill patients with respiratory failure by applying different physiotherapy methods. By conducting this study and developing the "Physiotherapy Protocol for Critically Ill Patients Treated in the ICU," physiotherapists worldwide could be encouraged to work using a unified and adapted method.
It is expected that the results, conclusions, and practical clinical recommendations derived from this study will be beneficial not only for rehabilitation specialists and intensivists in Lithuania but also for medical professionals working with respiratory diseases, including COVID-19 patients, at various stages of their treatment and consultation.
Implementing an appropriate physiotherapy procedure protocol is anticipated to bring economic benefits, as early physiotherapy is safe and can reduce the incidence of delirium, decrease the duration of patient sedation, shorten the number of days on mechanical ventilation, and minimize hospital stay duration. Additionally, it aims to restore or improve patients' functional and independence levels, help prevent ICU-acquired weakness, and can be easily implemented in intensive care units.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years of age)
- •Hospitalized in the Department of Reanimation and Intensive Therapy at LSMU Kaunas Clinics
- •Diagnosis of respiratory failure (KFN) based on the following TLK-10-AM codes: J96.00, J96.01, J96.9, J96.10, J96.11, J96.19, J96.90, J96.91, J96.99
- •Signed informed consent obtained from the patient or their legal representative
排除标准
- •Conscious patients who refuse to participate in the study
- •Unconscious patients whose legal representative does not consent
- •Recent episode of myocardial ischemia
- •Pregnancy
- •Heart rate < 40 bpm or > 130 bpm
- •Mean arterial pressure < 60 mmHg or > 110 mmHg
- •Oxygen saturation (SpO₂) ≤ 85%
- •Body temperature ≥ 38.5°C or ≤ 36.0°C
研究组 & 干预措施
Active Physiotherapy Intervention Arm (n=75)
The subjects of one group will receive active physiotherapy (eg: verticalization, sitting on the edge of the bed, active breathing exercises).
干预措施: Active Physiotherapy (Other)
Passive Physiotherapy Intervention Arm (n=75)
The other group will receive passive physiotherapy methods (eg: passive movements, electrostimulation of the diaphragm).
干预措施: Passive Physiotherapy (Other)
结局指标
主要结局
Change in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1) from baseline to ICU discharge
时间窗: From Day 1 of ICU admission to ICU discharge (up to 50 days)
Pulmonary function will be assessed using spirometry. The following parameters will be measured in liters and as percentages of predicted values: Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1). Measurements will be taken on Day 1 (baseline) and at ICU discharge. The mean change in FVC and FEV1 will be calculated to assess respiratory improvement.
次要结局
- Change in Arterial Oxygenation Parameters (PaO₂, FiO₂, and PaO₂/FiO₂ Ratio) During ICU Stay(From Day 1 of ICU admission to ICU discharge (up to 50 days))
- Change in Heart Rate and Arterial Blood Pressure Before and After Physiotherapy Session(Immediately before and immediately after each physiotherapy session, up to 50 days during ICU stay)
- Change in Intensive Care Unit Mobility Scale (ICUMS) Scores During ICU Stay(From Day 1 of physiotherapy to ICU discharge (up to 50 days))
研究者
Laura Rutkauskienė
Clinical Researcher
Lithuanian University of Health Sciences