Lung CancerAEROBIKANCT05267496
Oscillating Positive Expiratory Pressure Therapy for Patients With Thoracic Neoplasms Undergoing Chest Surgery
A study testing oscillating positive expiratory pressure device and Pulmonary rehabilitation in people with Lung Cancer and Mediastinal Tumor, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Mediastinal Tumor, Pleural Tumor
- What is being tested?
- oscillating positive expiratory pressure device and Pulmonary rehabilitation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteMexico
- Study dates
- 13 Aug 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oscillating Positive Expiratory Pressure Therapy on the Frequency of Pulmonary Atelectasis in Thoracic Cancer Patients Undergoing Chest Surgery
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:
Read more
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
- At patients´ first visit, demographic, clinical, and imaging variables will be obtained from INCan medical history and electronic record.
- 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).
- 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).
- 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
- 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.
- The patient will be instructed on the use of the device by the lung rehabilitation service and knowledge will be reinforced at each visit.
- The patient will place the date and time of use to assess adherence to treatment.
- Conditions
- Lung Cancer, Mediastinal Tumor, Pleural Tumor
- Being tested
- oscillating positive expiratory pressure device, Pulmonary rehabilitation
- Medical subject headings
- Lung Neoplasms, Mediastinal Neoplasms, Pleural Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oscillating positive expiratory pressure deviceDevice
Also called AEROBIKA
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 rehabilitationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Conventional rehabilitation | Other | Patients will receive conventional pulmonary rehabilitation Receives: Procedure: Pulmonary rehabilitation |
| AEROBIKA | Experimental | Patients will receive conventional pulmonary rehabilitation in addition to an oscillating positive expiratory pressure device Receives: Device: oscillating positive expiratory pressure device; Procedure: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Radiographs will be taken after 3 months of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start13 Aug 2019
- Primary completion28 Feb 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico
- Investigators
- Oscar Arrieta, MD,MSc, Principal investigator, Instituto Nacional de Cancerología de México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267496
- Sponsor's protocol ID
- CEI/1417/19
- Acronym
- AEROBIKA
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2022
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oscillating Positive Expiratory Pressure Therapy on the Frequency of Pulmonary Atelectasis in Thoracic Cancer Patients Undergoing Chest Surgery
- ClinicalTrials.gov ID
- NCT05267496
- Acronym / sponsor ID
- AEROBIKA / CEI/1417/19
- Conditions
- Lung Cancer, Mediastinal Tumor, Pleural Tumor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- At patients´ first visit, demographic, clinical, and imaging variables will be obtained from INCan medical history and electronic record.
- 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).
- 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).
- 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
- 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.
- The patient will be instructed on the use of the device by the lung rehabilitation service and knowledge will be reinforced at each visit.
- The patient will place the date and time of use to assess adherence to treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional rehabilitation | Other | Procedure: Pulmonary rehabilitationPatients will receive conventional pulmonary rehabilitation |
| AEROBIKA | Experimental | Device: oscillating positive expiratory pressure device, Procedure: Pulmonary rehabilitationPatients will receive conventional pulmonary rehabilitation in addition to an oscillating positive expiratory pressure device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oscillating positive expiratory pressure deviceAlso: AEROBIKAPatients 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. | Device | AEROBIKA |
| Pulmonary rehabilitationEducational 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 | Procedure or surgery | AEROBIKA, Conventional rehabilitation |
Primary outcome
Reduction of lung atelectasis
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar Arrieta, MD,MSc principal investigator
Instituto Nacional de Cancerología de México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oscillating positive expiratory pressure device and Pulmonary rehabilitation in people with Lung Cancer and Mediastinal Tumor, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of lung atelectasis (time frame: Radiographs will be taken after 3 months of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.