Comparison of Two Positive Expiratory Pressure Devices in Stable COPD Patients

Rush

Status: Withdrawn

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Device: RC-Cornet; Device: Pulmonica

Study type: Interventional

Funder types: Other

Identifiers

NCT02817529

PEP 001

Details and patient eligibility

About

Positive expiratory pressure (PEP) therapy is a device aiding airway clearance and secretion mobilization, also prevent the small airway from collapsing. The purpose of this research is to compare two PEP devices (Pulmonica, RC-Cornet) in stable COPD patients. Patients' compliance, satisfaction, 3 months and 6 months lung function test and life quality will be compared.

Full description

Background : Positive expiratory pressure (PEP) therapy is a type of airway clearance therapy in which the patient exhales through a resistance, which helps to shift the pressure points that aid mobilization of sputum and prevent the lung from collapsing. PEP therapy helps patients reduce the need for ventilatory support, improve hyperinflation and dyspnea. Although PEP devices are used, only a few studies have compared their beneficial effects and preference among COPD patients.

Objective: The purpose of this research is to compare two PEP devices (Pulmonica, RC-Cornet) in stable COPD patients. .

Methods:

A baseline assessment of the patient will be taken at the beginning, three months and the end of six months, including patients' ability to clear secretions via Breathlessness, Cough and Sputum Scale (BCSS), patients' self-reported quality of life via St. George's Respiratory questionnaire (SGRQ) and COPD Assessment Test (CAT) scores, pt's satisfaction with each device, and cardio-pulmonary function via pulmonary function test and six minute walk test in three and six months.

Subsequently, patients will be randomly assigned a PEP device (Pulmonica, RC-Cornet) and given instructions on how to properly use the device including frequency of PEP therapy. Each patient will receive a monthly follow-up call in order to determine adherence and satisfaction with PEP therapy, also BCSS, SGRQ and CAT scores.

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable COPD patients, younger than 80 years of age, older than 21 years and are willing to participate and give consent to participate

Exclusion criteria

• tracheotomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Pulmonica

Experimental group

Description:

The Pulmonica is a specially constructed and tuned Pulmonary Harmonica that produces deep, resonant, meditative sounds that can be felt vibrating in the lungs and sinuses. Participants who will be instructed to inhale and exhale through the PEP device at least ten times daily for up to six months.

Treatment:

Device: Pulmonica

RC-Cornet

Active Comparator group

Description:

The RC-Cornet is a device that provides oscillatory positive expiratory pressure (OPEP) therapy for the detachment and removal of pulmonary secretions. Through variable pressure settings and optional aerosolized medication delivery, patients realize maximum efficacy specific to their unique clinical needs.The RC-Cornet uses the patient's full expired air volume to produce pressure and oscillatory vibrations. Participants who will be instructed to inhale and exhale through the PEP device at least ten times daily for up to six months.

Treatment:

Device: RC-Cornet