ClinicalTrials.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

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Aug 2019, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Lung Neoplasms by Instituto Nacional de Cancerologia de Mexico — 3 open to participants now, 4 under way, none of them phase 3. Lung Neoplasms · Instituto Nacional de Cancerologia de Mexico.

Started
2019
the only one that year
No phase
2 of 10
none open now
Registered
8th of 10
by date

Among the 10 studies in Lung Neoplasms by Instituto Nacional de Cancerologia de Mexico, this one is the only one that started in 2019, is one of 2 with no phase, and was the 8th registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

Observational5 · 3 open
No phasethis study2 · 0 open
Phase 22 · 0 open
Phase 31 · 0 open

By the year they started

First in 2010; this study’s year is marked. 1 started in 2019.

What they test

Size and results

Median enrollment 96 across the 5 interventional studies, 281 across the 5 observational. Of the 5 that completed or were terminated, 2 (40%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 10 studies in Lung Neoplasms by Instituto Nacional de Cancerologia de Mexico, or all of them as a file.
02

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.
03

Conditions studied

  • Lung Cancer
  • Mediastinal Tumor
  • Pleural Tumor
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. Age from 18 to 75 years
  3. Peak Expiratory flow of 10 liters/min
  4. (ECOG) performance status 0-2
  5. score 70-100
  6. Patients willing and able to comply with all study procedures and follow-up visits.
  7. Patients who agree to participate and sign an 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2019 to primary completion in Feb 2023, 42 months.

Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's 42 months is above that.

Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2022
First posted
Mar 4, 2022
StartActual
Aug 13, 2019
Primary completionActual
Feb 28, 2023
CompletionEst.
Dec 31, 2026
Last update
Apr 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

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Discussion

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