Efficacy of Vakum Technology in Patients With Chronic Hypersecretion

Villa Pineta Hospital

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease; Chronic Bronchitis/Bronchiectasis

Treatments: Device: VAKÜM system; Other: conventional manual ELTGOL technique

Study type: Interventional

Funder types: Other

Identifiers

NCT01718067

2793

Details and patient eligibility

About

Mechanical devices to increase the individual's bronchial hygiene are commonly used to assist patients with chronic retention of secretions. VAKÜM technology has been recently developed with the aim to improve the respiratory condition in hypersecretive patients suffering from chronic respiratory diseases.

The aim of this study is to assess the clinical efficacy of VAKÜM technology in patients with hypersecretion, and chronic respiratory diseases a clinical trial has been designed.

Patients with chronic respiratory diseases, hypersecretion (sputum production >30 mL/die), and reduced cough efficiency (Peak Cough Expiratory Flow > 150 and < 300 L*min-1) referred to standard pulmonary rehabilitation (PR) will be included. Study design is a single-blind multicentre randomized trial with consecutive recruitment. Following a preliminary run-in period, group comparison will be made between Intervention group using VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique, and Control group using manual ELTGOL alone over 10 daily sessions.

Spirometric lung volumes, respiratory muscle strength, arterial blood gases, and quality of life will be recorded in both groups pre-to-post PR. Perceived dyspnea (by VAS scale), sputum volume and characteristics (on a semi-quantitative 3-point scale) and peak expiratory air flows (PEF and PCEF) will be registered on a daily basis over the study period. Primary outcome is the change in perceived dyspnea; in order to ensure 80% power to detect a 5 point (SD 5) group difference change in the primary outcome at the end of the study period as significant at the 0.05 level, at least 42 patients per group are needed. The minimum target sample size will be then fixed at 50 patients per group.

An higher and faster significant reduction of the perceived dyspnea is supposed in the Intervention group. Additional benefits among the secondary outcomes are also hypothesised in the same group.

Enrollment: 100 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with chronic respiratory diseases
• hypersecretion condition(sputum production >30 mL/die)
• reduced cough efficiency (Peak Cough Expiratory Flow > 150 and < 300 L*min- 1)
• patients admitted to standard pulmonary rehabilitation

Exclusion criteria

• not able to use the device
• concomitant cardiovascular or neoplastic diseases
• utilization of Non Invasive Ventilation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Vakum

Experimental group

Description:

VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique

Treatment:

Other: conventional manual ELTGOL technique

Device: VAKÜM system

Control

Active Comparator group

Description:

conventional manual ELTGOL technique

Treatment:

Other: conventional manual ELTGOL technique