TPEP® : a clinical history

Introduction

Secretions are the direct consequence of disabling respiratory diseases and are the major cause of infections, obstructions and lack of air exchange in the deep pulmonary area.

Airway clearance, which embraces reducing infections, improving gas exchange and pulmonary mechanics, was MPR’s primary target during their research. However, their objective was to identify a technology which could work more closely with the natural pressures found within the pulmonary system. The result was a technology built into one device which provided several benefits to the patient: airway clearance, targeted exercise of the airways and the effective distribution of medicines through aerosols.

Background

Positive expiratory pressure
The use of positive pressure in the expiratory phase (PeP), when applied correctly with the guidance of the physiotherapist, has demonstrated that this is a valid method in the removal of secretions.
A clinical study in 1997 demonstrated that the difference in alveoli capillary pressures is about 1,5 cm H20 (1).
Based on this concept MPR developed a technology,TPEP® (Temporary Positive Expiratory Pressure), which has an international patent (PCT). TPEP® provides a non invasive pressure of 1cmH2O on expiration only, which is halted just before the end of the expiratory phase. The interruption of pressure immediately reduces the internal pressure of the airways allowing the drainage of mucus and secretions to the upper airways so that they can be easily expectorated or removed. This outcome was achieved after several years of study and research which, in conclusion, demonstrated that low pressures can interact more effectively and non-invasively with respiratory airways compared to elevated pressures.
TPEP® was subsequently built into the first MPR device : UNIKO which was launched in 2005.

Regular use of UNIKO in patients who need specific respiratory physiotherapy demonstrates that UNIKO is beneficial for rehabilitation therapy,  helps to maintain elasticity in the airways and as a result pulmonary space is recruited which was previously less ventilated.

Aerosol therapy

During drug administration by aerosol most of the molecules with a diameter greater than 10 µm, are deposited in the oral cavity: in the mouth or in the first respiratory area and have difficulty in getting beyond the pharyngeal zone. Even slightly smaller molecules are not that effective because they are still deposited in the oral cavity.
Only molecules with a diameter between 1 and 5 µm are effective as they reach the small airways where they are deposited and achieve the desired therapeutic action. Even in ideal conditions, only a small percentage of drugs delivered by aerosols reach the peripheral lung area, normally between 2-10%.
The exchange of gases begins in the alveoli but it is absolutely essential that medication reaches the deeper level of the lungs in order to be effective.
Apart from the diameter of the molecules, secretions are the principal factor in the obstruction of drugs reaching the airways. In certain respiratory disease types, secretions are high in volume and/or in viscosity. Despite constant improvement in technology, it has not been possible to guarantee an effective deposition of drugs because the airways are not always accessible.
MPR consequently developed UNIKO TPEP® to provide aerosol therapy which would achieve an increase in the deposition of drugs by aerosol in the deeper lung area by a further 30% compared to traditional systems.
In collaboration with the University Hospital Pisana and using a new respiratory scintigraphic system used by the Cardio-Thoracic Department, it was possible to directly study lung behaviour with different pressures administered. The images obtained meant that the penetration and distribution of drugs could be quantified by comparing the different aerosol distribution systems. In this way it was possible to confirm the real efficacy of the system in the detachment and removal of secretions, and to verify the progressive health improvement in patients who were using UNIKO TPEP®.

Preparation for surgery and treatment post surgery

Patients affected by respiratory disease are at an elevated risk during anaesthesia compared to patients with healthy lungs. Preparing the patient for surgical procedure is of particular concern for hospital staff, in trying to reduce hospitalisation time and avoiding the consequences of post-operative ventilation.
UNIKO is a valid device for the preparation of patients for surgical intervention suffering from COPD : a study in 2008 demonstrated that, using UNIKO for 5 days before surgery, the elasticity of the lungs was improved and a deep drainage of the secretions was achieved (2). Moreover, as the pressure of 1 cm H2O is on expiration only, the breathing technique does not require a high level of work of breathing and therefore can be better tolerated by the post-surgery COPD patient.

TPEP® and UNIKO today

Since its launch in 2005, as part of its continuous improvement programme, MPR launched in the spring of 2010 a new version of the UNIKO device, UNIKO-TPEP® E, to meet the needs of both patient and clinician alike. The display is easy to read and intuitive which helps the patient to use the device correctly; as a result the breathing technique required for maximum patient benefit is readily understood, which means that there is further opportunity for patient compliance. TPEP® which provides airway clearance and exercise, together with aerosol therapy, is all still available in one lightweight unit.
UNIKO-TPEP® E is supplied complete, in its own carrying bag, with a kit for respiratory exercise, an aerosol chamber for liquid drugs distribution, and a spacer unit for MDI therapy.

For a full list of clinical studies and publications, please go to our clinical publications page

(1)(Hyatt RE et All. Philadelphia 1997; p 1400)
(2) (Abstract – MD  P Fazzi et al. ERS Berlin 2008)