Oscillating Positive Expiratory Pressure Therapy for Patients With Thoracic Neoplasms Undergoing Chest Surgery

NCT05267496 | Active Not Recruiting

• 1 other identifier: CEI/1417/19
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical study aims to assess the use of an oscillating positive expiratory pressure device (AEROBIKA) in patients with thoracic neoplasms who undergo chest surgery. The main questions it aims to answer are: If the use of the AEROBIKA device reduces the incidence of atelectasis in oncological patients undergoing lung resection. If the use of the AEROBIKA device reduces hospital readmission and days of hospital stay. Participants who accept to participate will be sorted to receive a conventional rehab therapy (group A), otherwise a conventional rehab therapy plus AEROBIKA device (group B). Researchers will compare patients from group A versus group B to see if patients develop atelectasis.

Conditions

Lung Cancer; Mediastinal Tumor; Pleural Tumor

Outcome Measures

Primary Outcomes (1)

• Reduction of lung atelectasis

  The reduction of atelectasis will be assessed according to a visual examination of thoracic radiography. In radiography, it is defined as a reduction of lung volume accompanied by an increase in opacity (radiography) or attenuation (CT) in the affected portion of the lung. Atelectasis is often associated with displacement of the cisura, bronchi, vessels, diaphragm, heart, or mediastinum. The distribution can be lobar, segmental, or subsegmental. They are classified: as linear, discoid, or platellary.

  Radiographs will be taken after 3 months of surgery

Study Arms (2)

Conventional rehabilitation

OTHER

Patients will receive conventional pulmonary rehabilitation

Procedure: Pulmonary rehabilitation

AEROBIKA

EXPERIMENTAL

Patients will receive conventional pulmonary rehabilitation in addition to an oscillating positive expiratory pressure device

Device: oscillating positive expiratory pressure device; Procedure: Pulmonary rehabilitation

Interventions

oscillating positive expiratory pressure device DEVICE

Patients randomized to the experimental arm of the study will receive an AEROBIKA oscillating positive expiratory pressure device in addition to the standard pulmonary rehabilitation program. The patient will receive instructions pertaining to the use of the device during the first evaluation visit to the rehabilitation service and this information will be reinforced at each follow-up visit. The patient will receive a log book in order to record date and time of use to assess treatment compliance and an instructions and maintenance booklet will be handed out to ensure adequate use of the device.

Also known as: AEROBIKA

AEROBIKA

Pulmonary rehabilitation PROCEDURE

Educational ventilatory techniques will be explained in order to re-educate respiratory muscles and increase patient awareness regarding the importance of complying with the exercise schedule to improve muscular strength. Including: Pre-surgical rehabilitation * Directed ventilation * Physical conditioning Post-surgical rehabilitation * Diaphragmatic mobilization * Thoracic expansion through incentive flow spirometry

AEROBIKA; Conventional rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a confirmed diagnosis of lung cancer, mediastinal tumors or mesothelioma who are candidates for surgical resection through thoracotomy or sternotomy.
• Measurable disease
• Age from 18 to 75 years
• Peak Expiratory flow of 10 liters/min
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Karnofsky score 70-100
• Patients willing and able to comply with all study procedures and follow-up visits.
• Patients who agree to participate and sign an informed consent form

You may not qualify if:

• Unstable systemic disease, including active infection, cardiac or hemodynamic diseases or neurological diseases.
• Patients with cognitive impairment who are not able to perform the pulmonary rehabilitation exercises.
• Oral cavity or facial trauma.
• Esophagus surgery
• Active hemoptysis
• Tympanic rupture or middle ear pathology.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Lung Neoplasms; Mediastinal Neoplasms; Pleural Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mediastinal Diseases; Thoracic Diseases; Pleural Diseases

Study Officials

• Oscar Arrieta, MD,MSc

  Instituto Nacional de Cancerología de México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the Thoracic Oncology Unit

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 4, 2022
• Study Start: August 13, 2019
• Primary Completion: February 28, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)