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

Not Applicable

Active, not recruiting

• Conditions: Pleural Tumor; Mediastinal Tumor; Lung Cancer
• Interventions: Device: oscillating positive expiratory pressure device; Procedure: Pulmonary rehabilitation

• Registration Number: NCT05267496
• Lead Sponsor: Instituto Nacional de Cancerologia de Mexico

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.

Detailed Description

Clinical evaluation

1. At patients´ first visit, demographic, clinical, and imaging variables will be obtained from INCan medical history and electronic record.

2. The patient will be called one week before the date of surgery to the Pulmonary Rehabilitation service. Evaluation of lung function will be carried out through tests by means of spirometry, oscilometry, gas exchange with oxygen saturation measurement and a submaximal exercise test which is the 6 minute walk. Tests will be performed at the following times: before surgery (basal) and after surgery (one month, 2 months and 3 months).

3. The EORTC, QLQ-C30 and QLQ LC13 quality of life questionnaires and a respiratory symptom questionnaire, St. George, will be performed at the same time (before surgery and after surgery (per month, 2 months and 3 months).

4. Patients will be referred to the Lung Rehabilitation Service and a respiratory rehabilitation programme will be initiated. All patients, regardless of the assigned group will carry out a conventional rehabilitation program which consists of TWO PHASES (Pre-surgical Rehabilitation and Post-surgical Rehabilitation).

INTERVENTION GROUP

1. At the first visit to the Pulmonary Rehabilitation service, the patient in the intervention group will receive an AEROBIKA device, at no cost, which the patient can take home.

2. The patient will be instructed on the use of the device by the lung rehabilitation service and knowledge will be reinforced at each visit.

3. The patient will place the date and time of use to assess adherence to treatment.

Study Timeline

• Study Start: 2019-08-13
• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-03-04
• Primary Completion: 2023-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AEROBIKA	oscillating positive expiratory pressure device	Patients will receive conventional pulmonary rehabilitation in addition to an oscillating positive expiratory pressure device
Conventional rehabilitation	Pulmonary rehabilitation	Patients will receive conventional pulmonary rehabilitation
AEROBIKA	Pulmonary rehabilitation	Patients will receive conventional pulmonary rehabilitation in addition to an oscillating positive expiratory pressure device

Primary Outcome Measures

Name	Time	Method
Reduction of lung atelectasis	Radiographs will be taken after 3 months of surgery	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.

Trial Locations

Locations (1)

Instituto Nacional de Cancerologia; 🇲🇽 Mexico City, Mexico