Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-03-15 @ 4:40 AM
Study NCT ID:
NCT01718067
Status:
UNKNOWN
Last Update Posted:
2014-12-10
First Post:
2012-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Vakum Technology in Patients With Chronic Hypersecretion
Sponsor:
Villa Pineta Hospital
Organization:
Study Overview
Official Title:
Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.
Status:
UNKNOWN
Status Verified Date:
2014-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: