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NCT Number: NCT07730034

Early Postoperative Physiotherapy to Prevent 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.

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Key information

Conditions

CABG Postoperative Pulmonary Complications (PPCs) Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Early postoperative physiotherapy

Procedure

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 care

Procedure

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

Primary outcomes

  1. Change in Forced Expiratory Volume in One Second (FEV1)

    Time frame: 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 outcomes

  1. Change in Peak Expiratory Flow (PEF)

    Time frame: 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.

  2. Postoperative pulmonary complications

    Time frame: 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.

  3. Change in Forced Expiratory Volume (FEV)

    Time frame: 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.

  4. Length of intensive care unit (ICU) stay

    Time frame: From ICU admission until ICU discharge (approximately up to 21 days after surgery).

    Duration of stay in the intensive care unit measured in days.

  5. Pain intensity

    Time frame: 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.

  6. Title Anxiety and stress

    Time frame: 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.

  7. 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.

    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.

  8. 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 oxygen partial pressure obtained from arterial blood gas analysis

  9. 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.

    Arterial carbon dioxide partial pressure obtained from arterial blood gas analysis

  10. Six-minute walk test (6MWT) distance

    Time frame: Before hospital discharge (approximately up to 21 days after surgery)

    Functional exercise capacity assessed by the six-minute walk test

  11. Lower limb muscle strength

    Time frame: Baseline (preoperative) and before hospital discharge (approximately up to 21 days after surgery)

    Lower limb muscle strength assessed using a digital dynamometer

Study contacts

Contact information is provided by the study sponsor or research team.

Dijana Filipović, MSc

CONTACT

[email protected]

+385 99 4663124

Sponsors and collaborators

Lead sponsor

Dijana Filipović

Other

Collaborators

  • Clinical Hospital Centre Zagreb

Registry information

Official study title

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

Acronym: EPP-CABG

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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