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

Instituto Nacional de Cancerologia de Mexico

Status: Active, not recruiting

Conditions: Pleural Tumor; Lung Cancer; Mediastinal Tumor

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05267496

CEI/1417/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 2 patient groups

Conventional rehabilitation

Other group

Description:

Patients will receive conventional pulmonary rehabilitation

Treatment:

Procedure: Pulmonary rehabilitation

AEROBIKA

Experimental group

Description:

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

Treatment:

Device: oscillating positive expiratory pressure device

Procedure: Pulmonary rehabilitation