Duchenne Muscular Dystrophy Clinical Trial
Official title:
Optimum Insufflation Capacity and Peak Cough Flow Augmentation in Patients With Neuromuscular Disease
Patients with underlying neuromuscular disorder (NMD) often suffer from weakness in the
inspiratory and expiratory muscles. Consequently they do not have the strength to generate
the minimum flow of 160 to 300 liters/minute for an efficient cough function. The restricted
cough function allows secretion to accumulate, which in turn causes narrowing of the airway
lumen and makes ventilation of the neuromuscular patient even more difficult. The patient's
susceptibility to infection increases again and the vicious circle repeats itself. Severe
secretion retention may even lead to ventilator failure. Effective secretion and cough
management instead reduces the risk for stay in hospital. Therefore, secretion and cough
management is a mandatory part of the therapeutic concept for treating patients with
neuromuscular disease.
The therapeutic efficacy of the Lung Insufflation Assist Maneuver(LIA) integrated in the
ventilator VENTIlogic LS-plus manufactured by Weinmann GmbH+Co KG was studied in a pilot
study carried out by the Dep. for Pediatric Pulmonology and Sleep Medicine at the University
Hospital of Essen/Germany in cooperation with Research & Development at Weinmann GmbH &Co
KG, Germany . The objective of the pilot study was to examine the therapeutic efficacy of
LIAM as a cough support function in patients with neuromuscular disease and indications for
mechanical ventilation.
We hypothesized that i) a certain insufflation maneuver pressure may be optimal to achieve
the highest individual peak cough flow and ii) that this pressure is below the pressure
needed to achieve the maximum insufflation capacity. We define the lowest insufflation
capacity at which the best individual PCF can be achieved as optimum insufflation capacity
(OIC). The study was performed using two different techniques in order to demonstrate that
findings are not dependent on maneuver details but are rather based on effects of maneuver
pressure. The protocol was limited to techniques which do not require breath stacking: i)
insufflation with an Intermittend Positive Pressure (IPPB) device and ii) with the
VENTIlogic LS using LIAM.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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