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Optimum Insufflation Capacity in NMD

Optimum Insufflation Capacity and Peak Cough Flow Augmentation in Patients With Neuromuscular Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01981915
Enrollment
40
Registered
2013-11-13
Start date
2011-01-31
Completion date
2013-03-31
Last updated
2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Respiratory Insufficiency, Duchenne Muscular Dystrophy, Spinal Muscular Atrophy

Keywords

Cough augmentation, Peak cough flow, hyperinsufflation

Brief summary

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.

Interventions

PROCEDUREIPPB

Lung insufflation with positive pressure using IPPB up from 10 to 40 mbar in 5 mbar increments and consecutive measurement of the insufflation volume

PROCEDURELIAM

Lung insufflation using the Lung Insufflation Assist maneuver of the Ventilogic LS mechanical ventilator (Weinmann Germany) with positive pressure up from 10 to 40 mbar in 5 mbar increments and consecutive measurement of the insufflation volume

Sponsors

Weinmann Geräte für Medizin GmbH + Co. KG
CollaboratorINDUSTRY
Universität Duisburg-Essen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* neuromuscular disorder * respiratory insufficiency * use of home mechanical ventilation

Exclusion criteria

* acute illness * history of pneumothorax

Design outcomes

Primary

MeasureTime frameDescription
insufflation capacitychange of lung volume with the procedure; during hospital stay on average 3 daysLung volume was measured during spontaneous breathing and after a lung insufflation assist maneuver.

Secondary

MeasureTime frameDescription
Peak cough flowchange of peak cough flow with the procedure; during hospital stay on average 3 daysPeak cough flow was measured during spontaneous breathing and after a lung insufflation assist maneuver.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026