Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery
NCT ID: NCT05416411
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
436 participants
INTERVENTIONAL
2022-07-20
2024-07-10
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Usual Care
Patients who are candidates for thoracic resection surgeries will be advised to stay active and quit smoking.
No interventions assigned to this group
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.
Inspiratory muscle training
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.
Interventions
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Inspiratory muscle training
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Istanbul University
OTHER
Responsible Party
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Emre Sertaç Bingül
Medical Doctor, Lecturer
Principal Investigators
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Emre S Bingul, MD
Role: PRINCIPAL_INVESTIGATOR
Istanbul University
Locations
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Acıbadem Mehmet Ali Aydınlar University, Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Istanbul University Istanbul Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Koc University, Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Fevzi Toraman, Prof
Role: primary
Zerrin Sungur, MD
Role: primary
Evren Şentürk, Prof
Role: primary
Other Identifiers
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2018-2/39
Identifier Type: -
Identifier Source: org_study_id