Oscillating Positive Expiratory Pressure Therapy for Patients With Thoracic Neoplasms Undergoing Chest Surgery (AEROBIKA)
Primary Purpose
Lung Cancer, Mediastinal Tumor, Pleural Tumor
Status
Active
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
oscillating positive expiratory pressure device
Pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional prevention trial for Lung Cancer
Eligibility Criteria
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.
Sites / Locations
- Instituto Nacional de Cancerologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Conventional rehabilitation
AEROBIKA
Arm Description
Patients will receive conventional pulmonary rehabilitation
Patients will receive conventional pulmonary rehabilitation in addition to an oscillating positive expiratory pressure device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05267496
First Posted
February 24, 2022
Last Updated
April 19, 2023
Sponsor
Instituto Nacional de Cancerologia de Mexico
1. Study Identification
Unique Protocol Identification Number
NCT05267496
Brief Title
Oscillating Positive Expiratory Pressure Therapy for Patients With Thoracic Neoplasms Undergoing Chest Surgery
Acronym
AEROBIKA
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cancerologia de Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Mediastinal Tumor, Pleural Tumor
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional rehabilitation
Arm Type
Other
Arm Description
Patients will receive conventional pulmonary rehabilitation
Arm Title
AEROBIKA
Arm Type
Experimental
Arm Description
Patients will receive conventional pulmonary rehabilitation in addition to an oscillating positive expiratory pressure device
Intervention Type
Device
Intervention Name(s)
oscillating positive expiratory pressure device
Other Intervention Name(s)
AEROBIKA
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Reduction of lung atelectasis
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Arrieta, MD,MSc
Organizational Affiliation
Instituto Nacional de Cancerología de México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Cancerologia
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oscillating Positive Expiratory Pressure Therapy for Patients With Thoracic Neoplasms Undergoing Chest Surgery
We'll reach out to this number within 24 hrs