Preoperative RESpiratory Training and MOBilization to Prevent Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery (RESMOB)

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Procedure, Thoracic Surgical
• Intervention / Treatment: Behavioral: Inspiratory muscle training

• Study Type: Interventional
• Enrollment (Estimated): 436
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emre S Bingul, MD; Phone Number: 31742 00902124142000; Email: emre.bingul@istanbul.edu.tr
• Study Contact Backup: Name: Zerrin Sungur, Prof; Phone Number: 31742 00902124142000; Email: zsungur@istanbul.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Istanbul University Istanbul Faculty of Medicine
    • Contact: Zerrin Sungur, MD; Email: zerrin.sungur@istanbul.edu.tr
    • Principal Investigator: Emre S Bingul, MD
    • Sub-Investigator: Zerrin Sungur, Prof
  • Istanbul, Turkey
    • Recruiting
    • Acıbadem Mehmet Ali Aydınlar University, Faculty of Medicine
    • Contact: Fevzi Toraman, Prof; Email: ftoraman@gmail.com
    • Principal Investigator: Fevzi Toraman, Prof
  • Istanbul, Turkey
    • Recruiting
    • Koc University, Faculty of Medicine
    • Contact: Evren Şentürk, Prof; Email: esenturk@kuh.ku.edu.tr
    • Principal Investigator: Evren Senturk, Prof
    • Sub-Investigator: Binnur Cavdaroglu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Patients who are candidates for thoracic resection surgeries will be advised to stay active and quit smoking.
Active Comparator: 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.	Behavioral: 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 Names: Walking (5000 steps/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Up to postoperative 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 days
Length of stay in hospital	Length of stay will be recorded as "days"	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	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	Up to 5 days
Visual Analog Scale dyspnea	Patients will be asked to describe their dyspnea in a scale of 0 to 10	Up to 5 days

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Emre S Bingul, MD, Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Estimated): July 10, 2024
• Study Completion (Estimated): July 10, 2024

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 23, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: prehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2018-2/39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No