The Effects of Multi-modality Physiotherapy in Delaying or Preventing COVID-19 Patient From Admitting to ICU: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Changes in Respiratory muscle performance
研究概览
简要总结
This study aims to evaluate the effectiveness of respiratory muscle training with COVID-19 patient, who has underlying health conditions, in order to delay or prevent them from admitting to ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
COVID-19 patient will be blinded from the study aim. The outcomes assessor will be blinded from the study aim and patient allocation.
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non- intubated patient diagnosed with moderate to severe pneumonia (confirmed by chest x-ray and officially reported) as secondary to COVID-19 with one more symptom such as:
- •Respiratory rate at ≥ 20 breath.min-
- •Oxygen saturation (SatO2) ≤ 90% at rest on room air.
- •Arterial partial pressure of oxygen (PaO2) ≤ 80 mmHg at resting.
- •PaO2/FiO2 ratio or P/F (is the ratio between the arterial partial pressure of oxygen and the percentage of oxygen supplied) < 300mmHg.
排除标准
- •Patient that has received upper abdominal or thoracic surgery recently (≤ 3 months).
- •Cancer patients.
- •Pregnant patients.
- •Patient mentally unstable.
- •Patient with unstable cardiovascular or neurological functions.
- •Patients refusing to participate in this clinical trial.
- •Patient less the 21 years old (According to Kuwaiti Law).
- •Patients who have a language barrier who cannot understand Arabic or English.
结局指标
主要结局
Changes in Respiratory muscle performance
时间窗: Baseline, 1st week, 2nd week, one month
Changes in Respiratory muscle performance will be determined by using the Respiratory Pressure Meter device. Patient will perform full inspiration through this device for 1.5 seconds via the mouth (nose occluded). The reading of the negative peak pressure that is maintained for 1 second in the device is a maximal inspiration peak.
次要结局
- Oxygen saturation(Daily from baseline to hospital discharge (2 weeks))
- Threshold IMT device(Daily from baseline to 1 month from admission)
- Heart rate(Daily from baseline to hospital discharge (2 weeks))
- Oxygen supplementation(Daily from baseline to hospital discharge (2 weeks).)
- Blood pressure(Daily from baseline to hospital discharge (2 weeks))
- Dyspnoea level(Daily from baseline to hospital discharge (2 weeks))
- Pain level(Daily from baseline to hospital discharge (2 weeks))
- Respiratory rate(Daily from baseline to hospital discharge (2 weeks))
- Oxygen flow rate(Daily from baseline to hospital discharge (2 weeks))
研究者
DR. JASSIM ALGHAITH
Specialist physical therapist, PhD.
Ministry of Health, Kuwait