跳至主要内容
临床试验/NCT07056764
NCT07056764已完成不适用

Development of Lung Vibration Equipment

Burapha University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年2月8日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Systolic blood pressure

研究概览

简要总结

This study designed a portable and easily accessible lung vibration device that is simple to use and can operate with both a battery system and a charging system for greater convenience. It helps enhance the effectiveness of mucus drainage, prevents complications, and reduces both the duration and cost of hospital treatment.

详细描述

Lung vibration device uses a motor as the power source to generate vibrations and has a shape similar to an iron. It is connected by an electrical cord in this section and can operate using either a battery system or a charging system. It features a vertically aligned handle perpendicular to the main body for a firm grip. The base of the device has a sponge head to absorb shock from the vibration during use, which is removable. The on/off switch is located at the end of the handle. This device uses 220-volt alternating current. The unit weighs approximately 1.1 kilograms and is made of strong and durable plastic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

盲法说明

Masking will not be employed in this crossover study, as both participants and investigators will be aware of the intervention administered in each period.

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • Aged 18-59 years
  • Inpatients at Burapha University Hospital, Mueang District, Chonburi Province, with pulmonary secretion retention
  • Referred by their attending physician for enhanced secretion clearance through physical therapy methods

排除标准

  • Having inflamed wounds on the chest or back
  • Having unstable vital signs, defined as: resting heart rate <60 or >100 beats per minute; blood pressure <90/60 or >120/80 mmHg; respiratory rate <12 or >20 breaths per minute; oxygen saturation <95%; and body temperature >37°C
  • Having a bleeding tendency, defined as a platelet count <20,000 per cubic millimeter
  • Taking medications that increase bleeding risk within 7 days prior to participation, including: Anticoagulants (such as Warfarin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban), Antiplatelet agents (such as Aspirin, Clopidogrel, Dipyridamole, Prasugrel, Ticagrelor)
  • Having an International Normalized Ratio (INR) >1.1 for those not on anticoagulants, and >3.0 for those on anticoagulants
  • Having subcutaneous emphysema
  • Experiencing severe hemoptysis (coughing up blood)
  • Having chest wall pain
  • Having acute spinal cord injury, rib fractures, or conditions associated with high fracture risk
  • Having skin grafts or burn wounds
  • Being admitted to intensive care units (ICU, RICU, or CICU)
  • Having untreated pneumothorax
  • Having an acute inflammatory process of the respiratory system
  • Having inflammatory or infectious conditions such as tuberculosis, lung abscess, or COVID-19
  • Having respiratory diseases that are contraindications or precautions for lung vibration, including COPD, uncomplicated pneumonia, asthma, lung cancer, or metastatic cancer

结局指标

主要结局

Systolic blood pressure

时间窗: Baseline (0 minutes) and immediately post-intervention (30 minutes)

Systolic blood pressure will be measured in mmHg unit

Diastolic blood pressure

时间窗: Baseline (0 minutes) and immediately post-intervention (30 minutes)

Diastolic blood pressure will be measured in mmHg unit

Body temperature

时间窗: Baseline (0 minutes) and immediately post-intervention (30 minutes)

Body temperature will be measured in degree Celsius

Oxygen saturation

时间窗: Baseline (0 minutes) and immediately post-intervention (30 minutes)

Partial pressure of oxygen saturation will be measured in percent

Sputum

时间窗: Immediately post-intervention (30 minutes)

Sputum will be measured for its quantity in ml unit and quality using photograph

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Piyapong Prasertsri

Associate Professor Dr.

Burapha University

研究点 (2)

Loading locations...

相似试验