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

NCT05416411 | Unknown DMC

• 1 other identifier: 2018-2/39
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 3

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.

Conditions

Postoperative Complications; Procedure, Thoracic Surgical

Keywords

prehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Preoperative MIP change

  7 days

• Length of stay in hospital

  Up to 15 days

• Visual Analog Scale thoracic rest pain

  Up to 5 days

• Visual Analog Scale thoracic coughing pain

  Up to 5 days

• Visual Analog Scale dyspnea

  Up to 5 days

Study Arms (2)

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.

Behavioral: Inspiratory muscle training

Interventions

Inspiratory muscle training BEHAVIORAL

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.

Also known as: Walking (5000 steps/day)

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (3)

Acıbadem Mehmet Ali Aydınlar University, Faculty of Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

Istanbul University Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

Koc University, Faculty of Medicine

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Interventions

Walking

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Emre S Bingul, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emre S Bingul, MD

CONTACT

00902124142000; emre.bingul@istanbul.edu.tr

Zerrin Sungur, Prof

CONTACT

00902124142000; zsungur@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Lecturer

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: July 20, 2022
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

TU (3)