Postoperative ComplicationsRESMOBNCT05416411
Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery
A study testing Inspiratory muscle training in people with Postoperative Complications and Procedure, Thoracic Surgical, run by Istanbul University at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Procedure, Thoracic Surgical
- What is being tested?
- Inspiratory muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 20 Jul 2022to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Acıbadem Mehmet Ali Aydınlar University, Faculty of Medicine
Istanbul
Fevzi Toraman, Prof, ftoraman@gmail.com
Fevzi Toraman, Prof
- Recruiting
Istanbul University Istanbul Faculty of Medicine
Istanbul
Zerrin Sungur, MD, zerrin.sungur@istanbul.edu.tr
Emre S Bingul, MD
- Recruiting
Koc University, Faculty of Medicine
Istanbul
Evren Şentürk, Prof, esenturk@kuh.ku.edu.tr
Evren Senturk, Prof
About this study
Official title: Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery (RESMOB): A Multi-center Randomized Controlled Trial
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.
- Being tested
- Inspiratory muscle training
- Keywords
- prehabilitation
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingBehavioural
Also called Walking (5000 steps/day)
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients who are candidates for thoracic resection surgeries will be advised to stay active and quit smoking. |
| Intervention group | Active comparator | 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. Receives: Behavioral: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to postoperative 5 days
Secondary outcomes (5)
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
Measured: 7 days
Length of stay in hospital
Length of stay will be recorded as "days"
Measured: Up to 15 days
Visual Analog Scale thoracic rest pain
Patients will be asked to describe their thoracic rest pain in a scale of 0 to 10
Measured: Up to 5 days
Visual Analog Scale thoracic coughing pain
Patients will be asked to describe their thoracic coughing pain in a scale of 0 to 10
Measured: Up to 5 days
Visual Analog Scale dyspnea
Patients will be asked to describe their dyspnea in a scale of 0 to 10
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start20 Jul 2022
- Primary completion10 Jul 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Sertaç Bingül, Istanbul University
- Investigators
- Emre S Bingul, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416411
- Sponsor's protocol ID
- 2018-2/39
- Acronym
- RESMOB
- Status last verified
- Dec 2023
- First submitted
- 8 Jun 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery (RESMOB): A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05416411
- Acronym / sponsor ID
- RESMOB / 2018-2/39
- Keywords
- prehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 436 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients who are candidates for thoracic resection surgeries will be advised to stay active and quit smoking. |
| Intervention group | Active comparator | Behavioral: Inspiratory muscle trainingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainingAlso: Walking (5000 steps/day)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. | Behavioural | Intervention group |
Primary outcome
The incidence of postoperative pulmonary complications
Time frame: Up to postoperative 5 days
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)
5 secondary outcomes
Preoperative MIP change
Time frame: 7 days
Length of stay in hospital
Time frame: Up to 15 days
Visual Analog Scale thoracic rest pain
Time frame: Up to 5 days
Visual Analog Scale thoracic coughing pain
Time frame: Up to 5 days
Visual Analog Scale dyspnea
Time frame: Up to 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emre S Bingul, MD principal investigator
Istanbul University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Postoperative Complications and Procedure, Thoracic Surgical, run by Istanbul University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emre S Bingul, MD (00902124142000 ext. 31742, emre.bingul@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative pulmonary complications (time frame: Up to postoperative 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.