Oscillating Positive Expiratory Pressure Therapy for Patients With Thoracic Neoplasms Undergoing … (NCT05267496) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Oscillating Positive Expiratory Pressure Therapy for Patients With Thoracic Neoplasms Undergoing Chest Surgery
Mexico72 participantsStarted 2019-08-13
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
Reduction of lung atelectasis
Timeframe: Radiographs will be taken after 3 months of surgery
Trial details
NCT IDNCT05267496
SponsorInstituto Nacional de Cancerologia de Mexico