Early Postoperative Physiotherapy in the Prevention Respiratory Insufficiency After Elective Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Forced Expiratory Volume in One Second (FEV1)
研究概览
简要总结
This study aims to determine whether starting respiratory physiotherapy one hour after removal of the breathing tube following elective coronary artery bypass graft (CABG) surgery leads to better recovery than the current standard approach, in which physiotherapy begins on the first postoperative day. The study will evaluate whether earlier physiotherapy improves lung function, reduces postoperative pulmonary complications, shortens intensive care unit and hospital stay, decreases pain and anxiety, and improves overall recovery after surgery. The main question is whether very early postoperative respiratory physiotherapy provides additional benefits for patients recovering from elective heart surgery compared with standard postoperative care.
详细描述
This study is designed to evaluate the effectiveness of early postoperative physiotherapy initiated one hour after extubation in patients undergoing elective coronary artery bypass graft (CABG) surgery. Postoperative pulmonary complications remain among the most frequent causes of morbidity following cardiac surgery and may contribute to prolonged intensive care unit and hospital stay, delayed functional recovery, and increased healthcare utilization. Early physiotherapy has been recognized as an important component of postoperative rehabilitation; however, the optimal timing for its initiation has not been clearly established. This study aims to investigate whether initiating physiotherapy one hour after extubation provides additional clinical benefits compared with the current standard practice of commencing physiotherapy on the first postoperative day. The protocol includes standardized perioperative management and physiotherapy procedures to ensure consistency of the intervention and outcome assessment. The study will be conducted at the University Hospital Centre Zagreb in accordance with the principles of Good Clinical Practice, the Declaration of Helsinki, and applicable ethical and regulatory requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years
- •Male and female participants
- •Elective coronary artery bypass grafting (CABG)
- •Body mass index (BMI) < 30 kg/m²
- •Left ventricular ejection fraction (EF) > 25%
- •Extubated on postoperative day 0 (POD 0)
- •Able and willing to provide written informed consent
- •Able to perform spirometry and follow study instructions
排除标准
- •Refusal or inability to provide informed consent
- •Emergency CABG surgery
- •Previous cardiac surgery
- •Severe cardiac arrhythmias (e.g., ventricular tachycardia/fibrillation, third-degree atrioventricular block)
- •Previous stroke
- •Motor impairment of upper or lower extremities due to neurological or musculoskeletal disease
- •Dyskinesia
- •Not extubated on POD 0
- •Significant postoperative neurological complications
- •Peripheral arterial disease of the lower extremities or previous lower-limb amputation
- •Acute or chronic pulmonary disease
- •Preoperative FEV1 <30% of predicted (greater than 70% reduction)
- •Inability to perform spirometry correctly
- •Cancelled surgery after preoperative assessment
- •Extubation later than 24 hours after surgery
- •Requirement for continuous positive airway pressure (CPAP) after extubation SpO₂ <90% one hour after extubation despite oxygen supplementation (4 L/min by nasal cannula)
- •Return to the operating room after the initial CABG procedure
- •Requirement for dialysis (acute or chronic)
研究组 & 干预措施
Early postoperative physiotherapy
Participants receive a standardized early postoperative physiotherapy program initiated within the first postoperative hours according to the study protocol, in addition to standard perioperative management.
干预措施: Early postoperative physiotherapy (Procedure)
Standard postoperative care
Participants receive standard postoperative care, including routine postoperative physiotherapy according to institutional practice.
干预措施: Standard postoperative care (Procedure)
结局指标
主要结局
Change in Forced Expiratory Volume in One Second (FEV1)
时间窗: From baseline (preoperative) until hospital discharge (approximately up to 21 days after surgery)
Change in FEV1 measured by portable spirometry to evaluate postoperative pulmonary function after coronary artery bypass graft surgery.
次要结局
- Change in Peak Expiratory Flow (PEF)(Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).)
- Postoperative pulmonary complications(From surgery until hospital discharge (approximately up to 21 days after surgery).)
- Change in Forced Expiratory Volume (FEV)(Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).)
- Length of intensive care unit (ICU) stay(From ICU admission until ICU discharge (approximately up to 21 days after surgery).)
- Pain intensity(Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).)
- Title Anxiety and stress(Baseline (preoperative) and before hospital discharge (approximately up to 21 days after surgery))
- Level of alertness and sedation(Before extubation; after physiotherapy on postoperative day 0 (when applicable); and before and after physiotherapy on postoperative day 1.)
- Arterial oxygen partial pressure (PaO₂)(Before extubation; after physiotherapy on postoperative day 0 (when applicable); and before and after physiotherapy on postoperative day 1.)
- Arterial carbon dioxide partial pressure (PaCO₂)(Before extubation; after physiotherapy on postoperative day 0 (when applicable); and before and after physiotherapy on postoperative day 1.)
- Six-minute walk test (6MWT) distance(Before hospital discharge (approximately up to 21 days after surgery))
- Lower limb muscle strength(Baseline (preoperative) and before hospital discharge (approximately up to 21 days after surgery))
研究者
Dijana Filipović
Principal Investigator
Alma Mater Europaea - Slovenia