The Effect of Acupuncture on Hemodynamics and Pain of Post Craniotomy Patients With Mechanical Ventilation in the ICU of Tangerang Regency Hospital Banten
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Respiration Rate
研究概览
简要总结
The aim of this clinical trial is to prove that acupuncture therapy combined with standard therapy can optimize hemodynamics and reduce pain in post-craniotomy patients with mechanical ventilation. The main questions it aims to answer are:
- Is there a difference in mean arterial pressure, pulse rate, respiratory rate, oxygen fraction and pain in the acupuncture therapy group combined with standard therapy compared to standard therapy after the 3rd therapy and compared to before therapy?
- Is there a difference in changes in ventilator mode in the acupuncture therapy group combined with standard therapy compared to standard therapy after the 3rd therapy?
- Are there any side effects in the acupuncture therapy group combined with standard therapy?
Researchers will compare acupuncture therapy combined with standard therapy to standard therapy only
Participants will:
- receive acupuncture therapy for 3 consecutive days
- outcomes will be assessed after 3 days of therapy.
详细描述
- Standard therapy is pharmacological therapy administered by the patient's attending anesthesiologist to research subjects in accordance with existing clinical practice guidelines. At the ICU of Tangerang District General Hospital, standard therapy administered to patients post-craniotomy with mechanical ventilation includes symptomatic therapy based on the patient's symptoms and condition (including antihypertensive medications, typically calcium channel blockers administered intravenously or orally), analgesics (typically fentanyl or morphine), and sedation (midazolam or propofol). This standard therapy is also administered according to the patient's clinical condition.
- Hemodynamic refers to parameters assess whether perfusion in the body is adequate or not, including how the heart pumps blood, how blood vessels carry blood throughout the body, and how blood nourishes and supplies oxygen to body tissues. Hemodynamic outcomes are assessed through vital signs such as blood pressure or Mean Arterial Pressure, pulse rate, respiratory rate, and oxygen requirements (FiO2).
- Critical Care Pain Observation Tools (CPOT) is a pain assessment tool for patients who are unable to communicate verbally and are on a ventilator. The assessment includes facial expressions, body movements, muscle tension, and compliance with the ventilator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
the outcome assessors will be blinded to group allocation
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
- •Male or female over 18 years old
- •Subjects who received craniotomy with vascular etiology
- •Conscious patients with GCS over 9 before craniotomy
- •Using SIMV mode mechanical ventilation
- •Family willing for the patient to participate in the study until completion and signed informed consent
排除标准
- •History of neuromusculoskeletal diseases such as myasthenia gravis or multiple sclerosis
- •Treatment for lung cancer and COVID-19
- •There is infection, scarring or malignancy in the acupuncture stabbing area
- •Patients with blood clotting disorders, platelets under
- •000/µl, patients on anticoagulant therapy with INR over 2.0
结局指标
主要结局
Respiration Rate
时间窗: Before therapy, Day 4
Measurement of the participant's respiratory rate over one minute.
Critical care Pain Observation Tools
时间窗: Before therapy, Day 4
Pain assessment in non-verbal and mechanically ventilated patients, including facial expressions, body movements, muscle tension, and compliance.
Mean Arterial Pressure
时间窗: Before therapy, Day 4
Average arterial pressure during one cardiac cycle of systole and diastole
Oxygen Fraction
时间窗: Before therapy, Day 4
Oxygen concentration in the inhaled gas mixture, as displayed on the patient monitor.
Heart Rate
时间窗: Before therapy, Day 4
Measurement of the participant's pulse rate over one minute.
次要结局
- Ventilator Mode(Day 4)
- Side Effect(Day 4)
研究者
Zellah Fransisca Natalia
Medical Doctor
Indonesia University