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

Sponsor

Instituto Nacional de Cancerologia de Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT05267496

Collaborator

(none)

Enrollment

Location

Arms

45.6

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lung cancer remains the leading neoplasm in terms of incidence and mortality worldwide, each year approximately 1.6 million deaths are attributable to patients with lung neoplasms. Importantly, among the estimated 1.8 million incident cases, 58% occur among patients in developing countries, with considerable challenges in terms of access to standard of care. Moreover, in Mexico 85% of patients are diagnosed with advanced-stage disease, for which the prognosis remains poor.

Incidence of thoracic surgery complications varies widely, from 5-80%. The main causes of morbidity and mortality among patients undergoing this intervention are respiratory complications. Among minor respiratory complications, lung atelectasis occur most frequently, presenting in 30-50% of patients and representing 3-4% of the mortality stemming from this procedure. Pre-operative management focuses on understanding the factors which predispose the appearance of pulmonary complications, including comorbidity control, reducing exposures and secretion management in the trans-surgical stage. Different rehabilitation approaches have been studied, among which the most common include incentive spirometry, respiratory exercises, chest physiotherapy , positive expiratory pressure (PEP) and oscillation therapy, which includes intrapulmonary percussive ventilation (IPV) and high-frequency chest wall oscillation.

The objective of this study is to assess the use of an oscillating positive expiratory pressure device (AEROBIKA) in patients with thoracic neoplasms who undergo chest surgery.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Mediastinal Tumor Pleural Tumor	Device: oscillating positive expiratory pressure device Procedure: Pulmonary rehabilitation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 13, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Conventional rehabilitation Patients will receive conventional pulmonary rehabilitation	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
Experimental: AEROBIKA Patients will receive conventional pulmonary rehabilitation in addition to an oscillating positive expiratory pressure device	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. Other Names: AEROBIKA 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

Arm

Intervention/Treatment

Other: Conventional rehabilitation

Patients will receive conventional pulmonary rehabilitation

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

Experimental: AEROBIKA

Patients will receive conventional pulmonary rehabilitation in addition to an oscillating positive expiratory pressure device

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.

Other Names:

AEROBIKA

Procedure: Pulmonary rehabilitation

Outcome Measures

Primary Outcome Measures

Incidence of lung atelectasis in patients undergoing thoracic surgery [3 months post-surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Cancerologia	Mexico City		Mexico	14080

Sponsors and Collaborators

Instituto Nacional de Cancerologia de Mexico

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oscar Gerardo Arrieta Rodríguez, Coordinator of the Thoracic Oncology Unit, Instituto Nacional de Cancerologia de Mexico

ClinicalTrials.gov Identifier:

NCT05267496

Other Study ID Numbers:

CEI/1417/19

First Posted:

Mar 4, 2022

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mediastinal Neoplasms

Study Results

No Results Posted as of Mar 21, 2022