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Completed

NCT Number: NCT01981915

Optimum Insufflation Capacity in NMD

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • acute illness
  • history of pneumothorax

Treatment and study plan

IPPB

Procedure

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

Other names: Intermittent Positive Pressure Breathing = IPPB

LIAM

Procedure

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

Other names: LIAM = Lung Insufflation Assist Maneuver

Primary outcomes

  1. insufflation capacity

    Time frame: change of lung volume with the procedure; during hospital stay on average 3 days

    Lung volume was measured during spontaneous breathing and after a lung insufflation assist maneuver.

Secondary outcomes

  1. Peak cough flow

    Time frame: change of peak cough flow with the procedure; during hospital stay on average 3 days

    Peak cough flow was measured during spontaneous breathing and after a lung insufflation assist maneuver.

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Collaborators

  • Weinmann Geräte für Medizin GmbH + Co. KG

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 13, 2013
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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