NCT05416411: RESMOB

Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery

Status unknown NA Last updated 27 December 2023

What this trial tests

NA trial testing Inspiratory muscle training in Postoperative Complications in 436 participants. Status unknown.

Timeline

20 July 2022

Primary endpoint
10 July 2024

10 July 2024

Quick facts

Lead sponsor	Istanbul University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	436
Start date	20 July 2022
Primary completion	10 July 2024
Estimated completion	10 July 2024
Sites	3 locations across Turkey (Türkiye)

Drugs / interventions tested

• Inspiratory muscle training

Conditions studied

• Postoperative Complications — all drugs for Postoperative Complications →
• Procedure, Thoracic Surgical — all drugs for Procedure, Thoracic Surgical →

Sponsor

Istanbul University

Who can join

18 and older, any sex, with Postoperative Complications or Procedure, Thoracic Surgical. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.