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

NCT ID: NCT05267496

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-13
• Study Completion Date: 2025-12-31

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.

Conditions

Lung Cancer; Mediastinal Tumor; Pleural Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Conventional rehabilitation

Patients will receive conventional pulmonary rehabilitation

Group Type: OTHER

Pulmonary rehabilitation

Intervention Type: 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

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

Group Type: EXPERIMENTAL

oscillating positive expiratory pressure device

Intervention Type: 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.

Pulmonary rehabilitation

Intervention Type: 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

Interventions

oscillating positive expiratory pressure 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.

Intervention Type: DEVICE

Pulmonary rehabilitation

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

Intervention Type: PROCEDURE

Other Intervention Names

AEROBIKA

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Cancerologia de Mexico

OTHER

Sponsor Role: lead

Responsible Party

Oscar Gerardo Arrieta Rodríguez

Coordinator of the Thoracic Oncology Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oscar Arrieta, MD,MSc

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cancerología de México

Locations

Instituto Nacional de Cancerologia

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

CEI/1417/19

Identifier Type: -

Identifier Source: org_study_id