CABG, Postoperative Pulmonary Complications (PPCs), Respiratory Insufficiency
Conditions
Keywords
Coronary artery bypass grafting (CABG), Early postoperative physiotherapy, Respiratory physiotherapy, Cardiac surgery, Pulmonary rehabilitation, Respiratory insufficiency
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEarly postoperative physiotherapy
Participants receive an early postoperative physiotherapy protocol initiated within the first 24 hours after elective cardiac surgery. The intervention includes breathing exercises, airway clearance techniques, early mobilization, progressive ambulation, and individualized therapeutic exercises according to a standardized protocol in addition to standard postoperative care.
PROCEDUREStandard postoperative care
Participants receive standard postoperative care, including routine postoperative physiotherapy according to institutional practice without the structured early physiotherapy protocol.
Sponsors
Dijana Filipović
Clinical Hospital Centre Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be assigned to one of two parallel study arms: an experimental group receiving the postoperative physiotherapy protocol and a control group receiving standard postoperative physiotherapy care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Forced Expiratory Volume in One Second (FEV1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Expiratory Flow (PEF) | Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery). | Change in peak expiratory flow measured using a portable spirometer to evaluate postoperative pulmonary function. |
| Postoperative pulmonary complications | From surgery until hospital discharge (approximately up to 21 days after surgery). | Incidence of postoperative pulmonary complications, including atelectasis, pneumonia, pleural effusion and secretion retention. |
| Change in Forced Expiratory Volume (FEV) | Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery). | Change in forced expiratory volume measured using a portable spirometer. |
| Length of intensive care unit (ICU) stay | From ICU admission until ICU discharge (approximately up to 21 days after surgery). | Duration of stay in the intensive care unit measured in days. |
| Pain intensity | Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery). | Postoperative pain assessed using the Visual Analogue Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain. |
| Title Anxiety and stress | Baseline (preoperative) and before hospital discharge (approximately up to 21 days after surgery) | Anxiety and stress assessed using the Depression Anxiety Stress Scale - 21 items (DASS-21). Scores for each subscale range from 0 to 42, with higher scores indicating greater anxiety and stress. |
| Level of alertness and sedation | Before extubation; after physiotherapy on postoperative day 0 (when applicable); and before and after physiotherapy on postoperative day 1. | Level of alertness and sedation assessed using the Richmond Agitation-Sedation Scale (RASS), Scores range from -5 to +4, where -5 indicates unarousable, 0 indicates alert and calm, and +4 indicates combative behavior. Higher scores indicate greater agitation. |
| 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 oxygen partial pressure obtained from arterial blood gas analysis |
| 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. | Arterial carbon dioxide partial pressure obtained from arterial blood gas analysis |
| Six-minute walk test (6MWT) distance | Before hospital discharge (approximately up to 21 days after surgery) | Functional exercise capacity assessed by the six-minute walk test |
| Lower limb muscle strength | Baseline (preoperative) and before hospital discharge (approximately up to 21 days after surgery) | Lower limb muscle strength assessed using a digital dynamometer |
Countries
Croatia
Contacts
CONTACTDijana Filipović, MSc
PRINCIPAL_INVESTIGATORDijana Filipović, MSc
Clinical Hospital Centre Zagreb
Outcome results
None listed