Preoperative inspiratory muscle training coupled to aerobic exercises to prevent postoperative pulmonary complications in patients undergoing thoracic surgery (INSPIRE study): a multicentre randomized controlled trial
Turkey (TurkMSIC) - Istanbul University Capa Medical Faculty, Istanbul
Istanbul University Istanbul Faculty Of Medicine, Department of Anesthesiology and Intensive Care, Topkapi Mh. Turgut Ozal Millet Cd. 34093 Fatih/Istanbul
Prof. Dr. Nuzhet Mert SENTURK
Prof. Dr. Nuzhet Mert SENTURK
Turkish, English
4 weeks
Cities/Months Jan Feb Mar Apr May Jun Jul Augt Sep Oct Nov Dec
No No No No No No Yes No No No No No
Type of Research Project
- Clinical Project with Laboratory work
What is the background of the project?
Please, provide the background of the project (Provide information about the project; min. 10 lines, max. 25 lines) Postoperative pulmonary complications (PPCs) that European Perioperative Clinical defines PPCs based on the presence of respiratory failure, pneumonia, atelectasis, pleural effusion, pneumothorax and bronchospasm, are the most frequent complications occurring after thoracic surgery and they are associated with prolonged hospital stay, decreased survival and expanding medical costs. Presently, PPCs are the most common serious adverse events with a reported incidence of 2%–50%. Consistent mechanisms involve reduction in functional residual capacity (FRC) and total lung capacity (TLC) that results in ventilation– perfusion mismatch, atelectasis and hypoxemia. So far, the importance of respiratory muscle dysfunction has largely been underestimated in the pathogenesis of PPCs. Weakness of the respiratory muscles is often associated with poor aerobic fitness in the context of chronic obstructive pulmonary disease (COPD), heart failure (HF) and muscular deconditioning. Both global aerobic physical training and inspiratory muscle training (IMT) have been shown effective in inducing morphological and functional changes in the diaphragm while improving the clinical conditions of patients with COPD or HF. Preliminary data also suggest that preoperative physical training contribute to lower pulmonary morbidity and to accelerate recovery after lung resection.
What is the aim of the project?
Main aim of the project is to question whether an individualized respiratory training program coupled with global aerobic exercises would protect the thoracic surgical patients against PPCs. In contrast with previous trials, the training program will be homebased and individualized according to the patient’s abilities. Preoperative aerobic endurance training (AET) and Inspiratory Muscle Training (IMT) by enhancing skeletal muscle function and improving tissue oxygen delivery may result in fewer PPCs. Secondary aims are to find whether preoperative AET-IMT: - induces phenotypic changes within the diaphragm and minimizes the early postoperative reduction in maximal inspiratory pressure and lung volumes - is associated with shorter hospital length of stay, fewer admission in intensive care unit and it represents a cost-effective perioperative intervention. -is associated with lower in-hospital morbidity and improved medium-term quality of life.
What techniques and methods are used?
What techniques and methods are used? Mention the steps/stages in this project. (Provide examples and avoid abbreviations; which tools will be used in general in this project?) -Economic evaluation - Cost Analysis: Direct health care costs (i.e. preoperative ambulatory treatment; in-hospital treatment costs, covering costs for staff and materials) will be reported using time units (e.g., time for nursing and anaesthesia services), units of other resources (e.g., drugs or medical materials), and current prices via the hospital cost accounting system. -Health-related quality of life: The Short Form 36 (SF-36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. Health-related Quality of Life Questionnaire, Self-report measures for adults for functions, symptoms, behaviors, and feelings by computer adaptive testing (Patient-Reported Outcomes Measurement Information System (PROMIS)) will be used. -Blinding: One researcher will screen for eligibility in the preoperative clinic and will perform the informed consent procedure and the baseline and follow-up measurements. Researcher, the surgeons, and other medical staff will be blinded for group allocation. Consenting patients will be randomized on-line using a dedicated website and research electronic data capture software randomization module (REDCAP) with stratification of each center. -Functional data: Maximal voluntary respiratory pressures will be registered at the mouth: from total lung capacity for maximal expiratory pressure (MEP) or from residual volume for maximal inspiratory pressure (MIP). To measure inspiratory muscle endurance, patients will be asked to breathe against a submaximal inspiratory load provided by the flow resistive loading device (POWERbreathe KH1or KH5, it is a high performance, hand held respiratory muscle training, assessment and monitoring device, intended for use by healthcare professionals for inspiratory muscle training and assessment in patients with dyspnoea, including patients with asthma, COPD, bronchitis, cystic fibrosis, emphysema, heart disease.), until task failure. Number of breaths, average duty cycle (inspiratory time as a fraction of the total respiratory cycle duration), average mean load, average mean power and total external inspiratory work will be recorded. -The diaphragm thickness (mm) will be assessed by Bmode ultrasonography (B-Mode Ultrasonography is a two-dimensional ultrasound image display composed of bright dots representing the ultrasound echoes. The brightness of each dot is determined by the amplitude of the returned echo signal. This allows for visualization and quantification of anatomical structures, as well as for the visualization of diagnostic and therapeutic procedures.) at FRC and at TLC using a linear 7.5-MHz linear probe.40 The largest excursion of the diaphragm will be recorded from the end of normal expiration to end of maximal inspiration. -The six-minute walk test will be performed by the researcher; the severity of dyspnoea will be rated using the modified Borg dyspnoea scale (It is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal), as well as the level of physical activity over 3 consecutive days (pre/post-IMT) with a multiaxis accelerometer. (Accelerometers have been used to calculate gait parameters, such as stance and swing phase. This kind of sensor can be used to measure or monitor people.)
What is the role of the student?
- The student will mainly observe
- If the project is clinical
- the student will be allowed to work with patients
- The tasks will be done under supervision
What are the tasks expected to be accomplished by the student?
The following tasks will be expected to be accomplished by the student: -Learning to follow-up a clinical study. (How do that data collecting from patients and storage, blinding) -Learning to preparing a patient for a surgial procedure. -Learning to following-up a patient during anaesthesia. -Learning to monitoring respiratory function tests in patients undergoing thoracic surgery. -Observing to a clinician for learning principles of working in operating theater (Hygen rules, becoming sterile etc.) and successfully applying during the exchange.
Will there be any theoretical teaching provided (preliminary readings, lectures, courses, seminars etc)
-1 hour weekly routine seminars about anesthesiology(egg. techniques, cases etc.) by different academicians of the department. -Weekly project meetings with researchers.
What is expected from the student at the end of the research exchange? What will be the general outcome of the student?
- The student will prepare a presentation
- The student will prepare a scientific report
What skills are required of the student? Is there any special knowledge or a certain level of studies needed?
Exchange students are required to have completed at least one clinic year in medical education.
Are there any legal limitations in the student’s involvement
Type of students accepted
This project accepts:
- Medical students
- Graduated students (less than 6 months)
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