Status:
UNKNOWN
Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery
Lead Sponsor:
Istanbul University
Conditions:
Postoperative Complications
Procedure, Thoracic Surgical
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Postoperative pulmonary complications (PPCs) are the most frequent complications occurring in patients undergoing thoracic surgery and they are associated with prolonged hospital stay, decreased survi...
Eligibility Criteria
Inclusion
- Adult patients (\> 18 years)
- Risk factors for PPCs (ARISCAT score \>27)
- Elective intra-abdominal surgery or intrathoracic surgery via an open or minimally-invasive approach, expected to last \> 120 min.
Exclusion
- Patients unable to understand the instructions and/or to perform the proposed training program (i.e., poor comprehension, chest pain)
- COPD GOLD Grade III and IV, lung fibrosis, documented bullae, severe emphysema, pneumothorax
- Patient with chest pain or at risk of pneumothorax
- Previous lung surgery
- Bilateral lung procedures
- Emergent surgery or organ transplant
- Planned mechanical ventilation after surgery
- Uncontrolled asthma
- Coronary heart disease with angina grade 3 or 4 Canadian Cardiovascular Society
- documented pulmonary arterial hypertension \>25mmHg mean pulmonary arterial pressure (PAP) at rest or \> 40 mmHg systolic PAP (estimated by ultrasound)
- Documented or suspected neuromuscular disease (thymoma, myasthenia, myopathies, muscular dystrophies, others)
- Intracranial injury or tumor
- Persistent hemodynamnic instability, intractable shock
- Pregnancy (excluded by anamnesis and/or laboratory analysis)
- Enrollment in another interventional study or refusal of informed consent
- Presence of one of the adverse events, listed as PPCs (aspiration, respiratory failure, pneumonia, atelectasis, cardiopulmonary edema, pleural effusion, pneumothorax)
- Pleural surgery only, sympathectomy surgery only, chest wall surgery only, mediastinal surgery only, lung transplantation
Key Trial Info
Start Date :
July 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2024
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT05416411
Start Date
July 20 2022
End Date
July 10 2024
Last Update
December 27 2023
Active Locations (3)
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1
Acıbadem Mehmet Ali Aydınlar University, Faculty of Medicine
Istanbul, Turkey (Türkiye)
2
Istanbul University Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye)
3
Koc University, Faculty of Medicine
Istanbul, Turkey (Türkiye)