Early Postoperative Physiotherapy to Prevent Respiratory Insufficiency After Elective Heart Surgery (NCT07730034) | Clinical Trial Compass
RecruitingNot Applicable
Early Postoperative Physiotherapy to Prevent Respiratory Insufficiency After Elective Heart Surgery
Croatia40 participantsStarted 2026-08-04
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Forced Expiratory Volume in One Second (FEV1)
Timeframe: From baseline (preoperative) until hospital discharge (approximately up to 21 days after surgery)