Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery (RESMOB): A Multi-center Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 survival and expanding medical costs. Implementation of structured and supervised exercise programs including endurance training (ET), respiratory muscle training (RMT) or a combination of both, within the short waiting period before surgery, has been shown to enhance patients' physical fitness, to provide protective effects against PPCs and therefore to spare health care resources by shortening intensive care unit (ICU) and hospital lengths of stay. More recently, a simple intervention consisting in patient's instruction and education about modifiable risk factors, optimal breathing pattern and the impact of physical exercise has emerged as a simple alternative intervention prevent PPCs, although the evidence is inconclusive. Therefore, the investigators propose a multicentre randomized, open, blinded end point controlled trial testing the hypothesis that preoperative education and instruction focused on breathing exercise and endurance training reduce the occurrence of PPCs in patients undergoing thoracic or abdominal surgery. Patients with Intermediate-to-high risks factors for PPCs will be randomized on a 1:1 basis into an intervention arm and a usual care arm (Control group). In the Education group, patients will be asked to use a flow resistive device (One set of 30 repetitions, two times a day and to increase their daily physical activities (\> 5'000 steps or equivalent) until surgery. Primary study endpoint will be the incidence of PPCs (e.g., atelectasis, pneumonia, respiratory failure) according to the European Perioperative Clinical Outcome definitions. Secondary outcomes will include non-respiratory complications, utilization of hospital resources (e.g., hospital length of stay, ICU admission),and preoperative changes in maximal inspiratory pressure \[MIP\]. Assuming a rate of 39% PPCs in the controls and a possible reduction to 26% in the intervention group, enrollment of 203 patients per group will provide 80% power with an alpha value of 0.05. Taking into account dropouts (5%) and in-hospital mortality rate (2%), a total of 436 surgical patients will be enrolled.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Acıbadem Mehmet Ali Aydınlar University, Faculty of Medicine
RECRUITING
Istanbul
Istanbul University Istanbul Faculty of Medicine
RECRUITING
Istanbul
Koc University, Faculty of Medicine
RECRUITING
Istanbul
Contact Information
Primary
Emre S Bingul, MD
emre.bingul@istanbul.edu.tr
00902124142000
Backup
Zerrin Sungur, Prof
zsungur@istanbul.edu.tr
00902124142000
Time Frame
Start Date: 2022-07-20
Estimated Completion Date: 2024-07-10
Participants
Target number of participants: 436
Treatments
No_intervention: Usual Care
Patients who are candidates for thoracic resection surgeries will be advised to stay active and quit smoking.
Active_comparator: Intervention group
Patients who are candidates for thoracic resection surgeries will be handed a flow resistive device that helps inspiratory muscle training (2\*30 repetitions a day for 7 days) and will be advised to walk 5000 steps a day.
Related Therapeutic Areas
Sponsors
Leads: Istanbul University

This content was sourced from clinicaltrials.gov