Not yet recruiting NCT07730034

Early Postoperative Physiotherapy to Prevent Respiratory Insufficiency After Elective Heart Surgery

No phase Interventional CABG Respiratory Insufficiency Postoperative Pulmonary Complications (PPCs)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Early postoperative physiotherapy, Standard postoperative care.
Who it may be relevant to: Registry conditions: CABG, Respiratory Insufficiency, Postoperative Pulmonary Complications (PPCs). Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Croatia
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Early Postoperative Physiotherapy in the Prevention Respiratory Insufficiency After Elective Heart Surgery

Overview

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

Procedure Early 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.
Procedure Standard postoperative care
Participants receive standard postoperative care, including routine postoperative physiotherapy according to institutional practice without the structured early physiotherapy protocol.

Primary outcome measures

Change in Forced Expiratory Volume in One Second (FEV1) [Time frame: From baseline (preoperative) until hospital discharge (approximately up to 21 days after surgery)]

Secondary outcome measures (11)

Change in Peak Expiratory Flow (PEF) [Time frame: Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).]
Postoperative pulmonary complications [Time frame: From surgery until hospital discharge (approximately up to 21 days after surgery).]
Change in Forced Expiratory Volume (FEV) [Time frame: Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).]
Length of intensive care unit (ICU) stay [Time frame: From ICU admission until ICU discharge (approximately up to 21 days after surgery).]
Pain intensity [Time frame: Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).]
Title Anxiety and stress [Time frame: Baseline (preoperative) and before hospital discharge (approximately up to 21 days after surgery)]
Level of alertness and sedation [Time frame: Before extubation; after physiotherapy on postoperative day 0 (when applicable); and before and after physiotherapy on postoperative day 1.]
Arterial oxygen partial pressure (PaO₂) [Time frame: 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) [Time frame: 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 [Time frame: Before hospital discharge (approximately up to 21 days after surgery)]
Lower limb muscle strength [Time frame: Baseline (preoperative) and before hospital discharge (approximately up to 21 days after surgery)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Treatment

Study locations

Croatia · 1 center

University Hospital Centre Zagreb — Zagreb

Identifiers

NCT: NCT07730034 · 02/013 AG

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗