Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05416411
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2022-06-08
Brief Title:
Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery RESMOB A Multi-center Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESMOB
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 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 patients 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 11 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 5000 steps or equivalent until surgery Primary study endpoint will be the incidence of PPCs eg atelectasis pneumonia respiratory failure according to the European Perioperative Clinical Outcome definitions Secondary outcomes will include non-respiratory complications utilization of hospital resources eg hospital length of stay ICU admissionand 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 005 Taking into account dropouts 5 and in-hospital mortality rate 2 a total of 436 surgical patients will be enrolled
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 11 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 5000 steps or equivalent until surgery Primary study endpoint will be the incidence of PPCs eg atelectasis pneumonia respiratory failure according to the European Perioperative Clinical Outcome definitions Secondary outcomes will include non-respiratory complications utilization of hospital resources eg hospital length of stay ICU admissionand 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 005 Taking into account dropouts 5 and in-hospital mortality rate 2 a total of 436 surgical patients will be enrolled
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None