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NCT Number: NCT05267496

Oscillating Positive Expiratory Pressure Therapy for Patients With Thoracic Neoplasms 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:

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Mediastinal Diseases Mediastinal Neoplasms Mediastinal Tumor Neoplasms Neoplasms by Site Pleural Diseases Pleural Neoplasms Pleural Tumor Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Diseases Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Cancerologia

Mexico City, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

oscillating positive expiratory pressure device

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.

Other names: AEROBIKA

Pulmonary rehabilitation

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancerologia de Mexico

Other

Registry information

Official study title

Effect of Oscillating Positive Expiratory Pressure Therapy on the Frequency of Pulmonary Atelectasis in Thoracic Cancer Patients Undergoing Chest Surgery

Acronym: AEROBIKA

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Mar 4, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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