Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery (RESMOB)
Primary Purpose
Postoperative Complications, Procedure, Thoracic Surgical
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory muscle training
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Complications focused on measuring prehabilitation
Eligibility 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
Sites / Locations
- Acıbadem Mehmet Ali Aydınlar University, Faculty of MedicineRecruiting
- Istanbul University Istanbul Faculty of MedicineRecruiting
- Koc University, Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Usual Care
Intervention group
Arm Description
Patients who are candidates for thoracic resection surgeries will be advised to stay active and quit smoking.
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.
Outcomes
Primary Outcome Measures
The incidence of postoperative pulmonary complications
Postoperative pulmonary complications will be investigated during the postoperative 5 days. These complications are named according to the European Perioperative Clinical Outcome (EPCO) definitions (Respiratory failure, aspiration pneumonitis, pneumonia, ARDS, pneumothorax, atelectasis, bronchospasm)
Secondary Outcome Measures
Preoperative MIP change
Maximum inspiratory pressure (MIP) will be measured during the enrollment and the training resistance will be set up according to this value. Once the training completed (after 7 days) another MIP measurement will be made
Length of stay in hospital
Length of stay will be recorded as "days"
Visual Analog Scale thoracic rest pain
Patients will be asked to describe their thoracic rest pain in a scale of 0 to 10
Visual Analog Scale thoracic coughing pain
Patients will be asked to describe their thoracic coughing pain in a scale of 0 to 10
Visual Analog Scale dyspnea
Patients will be asked to describe their dyspnea in a scale of 0 to 10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05416411
Brief Title
Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery
Acronym
RESMOB
Official Title
Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery (RESMOB): A Multi-center Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
July 10, 2024 (Anticipated)
Study Completion Date
July 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Procedure, Thoracic Surgical
Keywords
prehabilitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
436 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients who are candidates for thoracic resection surgeries will be advised to stay active and quit smoking.
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Inspiratory muscle training
Other Intervention Name(s)
Walking (5000 steps/day)
Intervention Description
Patients will do inspiratory muscle training via a flow resistive device. Priorly, maximum inspiratory pressure will be measured. Afterwards, the training device will be set to 10% increased value of maximum inspiratory pressure (MIP), and the training will be completed two times and 30 repetitions a day during preoperative 7 days. Meanwhile patients will be advised to walk 5000 steps a day during the intervention period.
Primary Outcome Measure Information:
Title
The incidence of postoperative pulmonary complications
Description
Postoperative pulmonary complications will be investigated during the postoperative 5 days. These complications are named according to the European Perioperative Clinical Outcome (EPCO) definitions (Respiratory failure, aspiration pneumonitis, pneumonia, ARDS, pneumothorax, atelectasis, bronchospasm)
Time Frame
Up to postoperative 5 days
Secondary Outcome Measure Information:
Title
Preoperative MIP change
Description
Maximum inspiratory pressure (MIP) will be measured during the enrollment and the training resistance will be set up according to this value. Once the training completed (after 7 days) another MIP measurement will be made
Time Frame
7 days
Title
Length of stay in hospital
Description
Length of stay will be recorded as "days"
Time Frame
Up to 15 days
Title
Visual Analog Scale thoracic rest pain
Description
Patients will be asked to describe their thoracic rest pain in a scale of 0 to 10
Time Frame
Up to 5 days
Title
Visual Analog Scale thoracic coughing pain
Description
Patients will be asked to describe their thoracic coughing pain in a scale of 0 to 10
Time Frame
Up to 5 days
Title
Visual Analog Scale dyspnea
Description
Patients will be asked to describe their dyspnea in a scale of 0 to 10
Time Frame
Up to 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emre S Bingul, MD
Phone
00902124142000
Ext
31742
Email
emre.bingul@istanbul.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Zerrin Sungur, Prof
Phone
00902124142000
Ext
31742
Email
zsungur@istanbul.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emre S Bingul, MD
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acıbadem Mehmet Ali Aydınlar University, Faculty of Medicine
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fevzi Toraman, Prof
Email
ftoraman@gmail.com
First Name & Middle Initial & Last Name & Degree
Fevzi Toraman, Prof
Facility Name
Istanbul University Istanbul Faculty of Medicine
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zerrin Sungur, MD
Email
zerrin.sungur@istanbul.edu.tr
First Name & Middle Initial & Last Name & Degree
Emre S Bingul, MD
First Name & Middle Initial & Last Name & Degree
Zerrin Sungur, Prof
Facility Name
Koc University, Faculty of Medicine
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evren Şentürk, Prof
Email
esenturk@kuh.ku.edu.tr
First Name & Middle Initial & Last Name & Degree
Evren Senturk, Prof
First Name & Middle Initial & Last Name & Degree
Binnur Cavdaroglu, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery
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