The Effect of the Safe Early Mobilization Protocol Developed for Patients Underwent Coronary Artery Bypass Graft Surgery on Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Distance walked during postoperative mobilization
研究概览
简要总结
Aim: This study aimed to evaluate the effect of a Safe Early Mobilization Protocol (SEMP) developed for patients undergoing coronary artery bypass graft (CABG) surgery on patient outcomes.
Design: A single-center, parallel-group, randomized controlled trial. Methods: The study was conducted with 60 patients in 2023. The intervention group received a Safe Early Mobilization Protocol including bedside elevation, deep breathing and coughing exercises, sitting upright in bed, sitting on the edge of the bed, standing, ambulation, and sitting in a bedside chair from the day of surgery until the fourth postoperative day. The control group received routine mobilization care. Respiratory parameters, orthostatic hypotension (OH), orthostatic intolerance (OI), mobilization distance, anxiety level, and hospital stay were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hemodynamic stability, defined as:
- •Resting heart rate <110/min
- •Mean arterial pressure between 60-110 mmHg
- •Oxygen saturation (SpO₂) >88%
- •Receiving dopamine infusion ≤5 mcg/kg/min at the time of enrollment
- •No auditory, speech, or visual impairments
- •No neurological contraindications (e.g., cerebrovascular accident [CVA], ataxia, multiple sclerosis [MS])
- •No orthopedic contraindications that prevent mobilization (e.g., fractures or sequelae)
- •Provided informed consent to participate in the study
- •Age ≥18 years
- •Able to speak Turkish
- •Literate patients
排除标准
- •Requirement for intra-aortic balloon pump (IABP) support
- •Postoperative cerebrovascular events
- •High-dose inotropic drug infusion in the early postoperative period:
- •Dopamine ≥10 mcg/kg/min
- •Norepinephrine ≥0.5 mcg/kg/min
- •Concurrent dopamine and norepinephrine infusion
- •Severe arrhythmias preventing mobilization, including:
- •Sinus tachycardia ≥120/min
- •Rapid atrial fibrillation
- •Ventricular tachycardia
- •Ventricular fibrillation
- •Advanced chronic obstructive pulmonary disease (COPD) or bronchiectasis
- •Diagnosed anxiety disorders
研究组 & 干预措施
SEMP
A safe early mobilization protocol developed by the researchers was applied.
干预措施: The safe early mobilization protocol (Other)
Control group
The routine protocol used in the hospital was applied.
干预措施: Control Group (Other)
结局指标
主要结局
Distance walked during postoperative mobilization
时间窗: Postoperative Days 1, 2, and 3.
Distance walked (meters) during routine postoperative mobilization in the hospital corridor, measured using a standardized corridor distance measurement protocol. Greater distances indicate better postoperative mobility.
Number of Participants With Orthostatic Hypotension
时间窗: Daily postoperative measurements for up to 3 days.
Orthostatic hypotension defined as a ≥20 mmHg decrease in systolic BP and/or ≥10 mmHg decrease in diastolic BP.
Number of Participants With Orthostatic Intolerance
时间窗: Daily postoperative assessments for up to 3 days.
Orthostatic intolerance defined as the presence of dizziness, nausea, weakness, blurred vision, or syncope.considered as OI.
Oxygen Saturation Level (%)
时间窗: Daily postoperative measurements for up to 3 days.
Peripheral oxygen saturation (SpO₂) measured using pulse oximetry.
State Anxiety Scale Score
时间窗: Postoperative day 1 and postoperative day 4.
The State Anxiety Inventory (STAI-S) will be used (score range: 20-80; higher scores indicate worse anxiety).
Six-Minute Walk Test Distance (Meters)
时间窗: Postoperative day 4.
Distance walked during the Six-Minute Walk Test (0-∞ meters; higher distance indicates better functional capacity).
次要结局
- Number of Participants With Orthostatic Hypotension(Daily postoperative measurements for up to 3 days.)
- Number of Participants With Orthostatic Intolerance(Daily postoperative assessments for up to 3 days.)
- Oxygen Saturation Level (%)(Daily postoperative measurements for up to 3 days.)
- State Anxiety Scale Score(Postoperative day 1 and postoperative day 4.)
- Six-Minute Walk Test Distance (Meters)(Postoperative day 4.)
- Length of Hospital Stay (Days)(From postoperative day 0 until hospital discharge (up to 30 days).)
研究者
Hulya BULUT
Prof. Dr.
Gazi University