Preoperative respiratory training to prevent lung complications after thoracic surgery
Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery (RESMOB): A Multi-center Randomized Controlled Trial
NA · Istanbul University · NCT05416411
This study is testing whether pre-surgery breathing exercises and physical training can help people having thoracic surgery avoid lung problems afterward.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 436 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istanbul University (other) |
| Locations | 3 sites (Istanbul and 2 other locations) |
| Trial ID | NCT05416411 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of preoperative respiratory training and mobilization in reducing postoperative pulmonary complications (PPCs) in patients undergoing thoracic surgery. The study will implement structured exercise programs, including endurance and respiratory muscle training, to enhance patients' physical fitness before surgery. By educating patients on modifiable risk factors and optimal breathing techniques, the trial seeks to provide a simple yet effective intervention to mitigate the risks associated with PPCs. The multicenter randomized design will allow for a comprehensive assessment of the intervention's impact across different patient populations.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients over 18 years old who are at risk for postoperative pulmonary complications and are scheduled for elective thoracic surgery lasting more than 120 minutes.
Not a fit: Patients with severe respiratory conditions, such as advanced COPD or those requiring mechanical ventilation post-surgery, may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative pulmonary complications, leading to shorter hospital stays and improved patient outcomes.
How similar studies have performed: Previous studies have shown that prehabilitation strategies can effectively reduce postoperative complications, suggesting that this approach may yield positive results as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Istanbul and 2 other locations
- Acıbadem Mehmet Ali Aydınlar University, Faculty of Medicine — Istanbul, Turkey (RECRUITING)
- Istanbul University Istanbul Faculty of Medicine — Istanbul, Turkey (RECRUITING)
- Koc University, Faculty of Medicine — Istanbul, Turkey (RECRUITING)
Study contacts
- Principal investigator: Emre S Bingul, MD — Istanbul University
- Study coordinator: Emre S Bingul, MD
- Email: emre.bingul@istanbul.edu.tr
- Phone: 00902124142000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Complications, Procedure, Thoracic Surgical, prehabilitation