Early Postoperative Physiotherapy to Prevent Respiratory Insufficiency After Elective Heart Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDijana Filipović
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-80 years
Male and female participants
Elective coronary artery bypass grafting (CABG)
Body mass index (BMI) < 30 kg/m²
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Early postoperative physiotherapy
Procedure/SurgeryParticipants 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 care
Procedure/SurgeryParticipants receive standard postoperative care, including routine postoperative physiotherapy according to institutional practice without the structured early physiotherapy protocol.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Early postoperative physiotherapyExperimental treatment 1 intervention
Group B: Standard postoperative careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline (preoperative) until hospital discharge (approximately up to 21 days after surgery)Secondary outcomes
1
Change in Peak Expiratory Flow (PEF)
Change in peak expiratory flow measured using a portable spirometer to evaluate postoperative pulmonary function.
Time frame
Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).2
Postoperative pulmonary complications
Incidence of postoperative pulmonary complications, including atelectasis, pneumonia, pleural effusion and secretion retention.
Time frame
From surgery until hospital discharge (approximately up to 21 days after surgery).3
Change in Forced Expiratory Volume (FEV)
Change in forced expiratory volume measured using a portable spirometer.
Time frame
Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).4
Length of intensive care unit (ICU) stay
Duration of stay in the intensive care unit measured in days.
Time frame
From ICU admission until ICU discharge (approximately up to 21 days after surgery).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dijana Filipović
Lead sponsor
Alma Mater Europaea - Slovenia
Sponsor institution
Clinical Hospital Centre Zagreb
Collaborator
Source ClinicalTrials.gov