CClinicalTrials.gg
Active, not recruitingNCT05267496AEROBIKAUpdated Apr 8, 2026

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

An interventional study of oscillating positive expiratory pressure device and Pulmonary rehabilitation in Lung Cancer, Mediastinal Tumor and Pleural Tumor, sponsored by Instituto Nacional de Cancerologia de Mexico. Active, not recruiting at 1 site in Mexico. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Instituto Nacional de Cancerologia de Mexico · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Lung Cancer
  • Mediastinal Tumor
  • Pleural Tumor
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Other
    Conventional rehabilitation

    Patients will receive conventional pulmonary rehabilitation

    Procedure: Pulmonary rehabilitation

  • Experimental
    AEROBIKA

    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

  • Deviceoscillating 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.

    Also known as: AEROBIKA

  • ProcedurePulmonary 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

05

What researchers measure

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.

    Time frame: Radiographs will be taken after 3 months of surgery

06

Study locations

1 site
  • Instituto Nacional de Cancerologia
    Mexico City, 14080, Mexico
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05267496
Lead sponsor
Instituto Nacional de Cancerologia de Mexico
Responsible party
Oscar Gerardo Arrieta Rodríguez (Coordinator of the Thoracic Oncology Unit, Instituto Nacional de Cancerologia de Mexico) — Principal investigator
First posted
Mar 4, 2022
Start date
Aug 13, 2019
Primary completion
Feb 28, 2023
Completion
Dec 31, 2026 (estimated)
Last update
Apr 8, 2026

Study contacts

Oscar Arrieta, MD,MSc
principal investigator · Instituto Nacional de Cancerología de México

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion