Clinical trial NCT05267496: Oscillating Positive Expiratory Pressure Therapy for Patients With Thoracic Neoplasms Undergoing Chest Surgery
Official title: Effect of Oscillating Positive Expiratory Pressure Therapy on the Frequency of Pulmonary Atelectasis in Thoracic Cancer Patients Undergoing Chest Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Mediastinal Tumor
Pleural Tumor
Lead sponsor: Instituto Nacional de Cancerologia de Mexico
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: Reduction of lung atelectasis
timeFrame: Radiographs will be taken after 3 months of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia
Study officials:
affiliation: Instituto Nacional de Cancerología de México
name: Oscar Arrieta, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References: