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Optimum Insufflation Capacity in NMD

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ClinicalTrials.gov Identifier: NCT01981915
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : November 13, 2013
Sponsor:
Collaborator:
Weinmann Geräte für Medizin GmbH + Co. KG
Information provided by (Responsible Party):
Uwe Mellies, Universität Duisburg-Essen

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.


Condition or disease Intervention/treatment Phase
Duchenne Muscular Dystrophy Spinal Muscular Atrophy Chronic Respiratory Insufficiency Procedure: IPPB Procedure: LIAM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optimum Insufflation Capacity and Peak Cough Flow Augmentation in Patients With Neuromuscular Disease
Study Start Date : January 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013


Arm Intervention/treatment
Experimental: Lung Insufflation Volume
Measurement of the lung volume after hyperinsufflation with positive pressure by IPPB or LIAM
Procedure: IPPB
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 Name: Intermittent Positive Pressure Breathing = IPPB

Procedure: LIAM
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 Name: LIAM = Lung Insufflation Assist Maneuver

Experimental: Peak Cough Flow
Measurement of the peak cough flow after hyperinsufflation with positive pressure by IPPB or LIAM
Procedure: IPPB
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 Name: Intermittent Positive Pressure Breathing = IPPB

Procedure: LIAM
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 Name: LIAM = Lung Insufflation Assist Maneuver




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • acute illness
  • history of pneumothorax

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981915


Locations
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Germany
University of Essen, Children`s Hospital, Dep. of Pediatric Pulmonology
Essen, NRW, Germany, 45122
Sponsors and Collaborators
Universität Duisburg-Essen
Weinmann Geräte für Medizin GmbH + Co. KG
Investigators
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Principal Investigator: Uwe Mellies, MD University of Essen, Germany

Publications:
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Responsible Party: Uwe Mellies, Priv.-Doz. Dr. med., Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01981915     History of Changes
Other Study ID Numbers: OIC2013
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013
Keywords provided by Uwe Mellies, Universität Duisburg-Essen:
Cough augmentation
Peak cough flow
hyperinsufflation
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Respiratory Insufficiency
Muscular Atrophy
Muscular Atrophy, Spinal
Pulmonary Valve Insufficiency
Atrophy
Pathological Conditions, Anatomical
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases