CABGEPP-CABGNCT07730034
Early Postoperative Physiotherapy to Prevent Respiratory Insufficiency After Elective Heart Surgery
A study testing Early postoperative physiotherapy and Standard postoperative care in people with CABG and Respiratory Insufficiency, run by Dijana Filipović at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CABG, Respiratory Insufficiency, Postoperative Pulmonary Complications (PPCs)
- What is being tested?
- Early postoperative physiotherapy and Standard postoperative care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- 4 Aug 2026to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Centre Zagreb
Zagreb, 10000
Dijana Filipović, MSc, +385 99 4663 124, dijana.filipovic@kbc-zagreb.hr
About this study
Official title: Early Postoperative Physiotherapy in the Prevention Respiratory Insufficiency After Elective Heart Surgery
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.
Read the 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.
- Being tested
- Early postoperative physiotherapy, Standard postoperative care
- Keywords
- Coronary artery bypass grafting (CABG), Early postoperative physiotherapy, Respiratory physiotherapy, Cardiac surgery, Pulmonary rehabilitation, Respiratory insufficiency
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early postoperative physiotherapyProcedure or surgery
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.
Standard postoperative careProcedure or surgery
Participants receive standard postoperative care, including routine postoperative physiotherapy according to institutional practice without the structured early physiotherapy protocol.
| Study group | Role | What they receive |
|---|---|---|
| Early postoperative physiotherapy | Experimental | 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. Receives: Procedure: Early postoperative physiotherapy |
| Standard postoperative care | Active comparator | Participants receive standard postoperative care, including routine postoperative physiotherapy according to institutional practice. Receives: Procedure: Standard postoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Expiratory Volume in One Second (FEV1)
Change in FEV1 measured by portable spirometry to evaluate postoperative pulmonary function after coronary artery bypass graft surgery.
Measured: From baseline (preoperative) until hospital discharge (approximately up to 21 days after surgery)
Secondary outcomes (11)
Change in Peak Expiratory Flow (PEF)
Change in peak expiratory flow measured using a portable spirometer to evaluate postoperative pulmonary function.
Measured: Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).
Postoperative pulmonary complications
Incidence of postoperative pulmonary complications, including atelectasis, pneumonia, pleural effusion and secretion retention.
Measured: From surgery until hospital discharge (approximately up to 21 days after surgery).
Change in Forced Expiratory Volume (FEV)
Change in forced expiratory volume measured using a portable spirometer.
Measured: Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).
Length of intensive care unit (ICU) stay
Duration of stay in the intensive care unit measured in days.
Measured: From ICU admission until ICU discharge (approximately up to 21 days after surgery).
Pain intensity
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.
Measured: Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).
Title Anxiety and stress
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.
Measured: Baseline (preoperative) and before hospital discharge (approximately up to 21 days after surgery)
Level of alertness and sedation
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.
Measured: Before extubation; after physiotherapy on postoperative day 0 (when applicable); and before and after physiotherapy on postoperative day 1.
Arterial oxygen partial pressure (PaO₂)
Arterial oxygen partial pressure obtained from arterial blood gas analysis
Measured: 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)
Arterial carbon dioxide partial pressure obtained from arterial blood gas analysis
Measured: 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
Functional exercise capacity assessed by the six-minute walk test
Measured: Before hospital discharge (approximately up to 21 days after surgery)
Lower limb muscle strength
Lower limb muscle strength assessed using a digital dynamometer
Measured: Baseline (preoperative) and before hospital discharge (approximately up to 21 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start4 Aug 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dijana Filipović
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb
- Responsible party
- Sponsor-investigator, Dijana Filipović, Alma Mater Europaea - Slovenia
- Investigators
- Dijana Filipović, MSc, Principal investigator, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730034
- Sponsor's protocol ID
- 02/013 AG
- Acronym
- EPP-CABG
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because participant confidentiality will be protected in accordance with the study protocol and ethics committee requirements.