Oscillating Positive Expiratory Pressure Therapy for Patients With Thoracic Neoplasms Undergoing Chest Surgery

Lung Cancer Clinical Trial

— AEROBIKA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05267496
• Other study ID #: CEI/1417/19
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 13, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Instituto Nacional de Cancerologia de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: December 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Mediastinal Neoplasms
• Mediastinal Tumor

Intervention

Device:
• oscillating 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.

Procedure:
• Pulmonary 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

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cancerologia	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Radiographs will be taken after 3 months of surgery