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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

Tracking Information
First Submitted Date  ICMJE October 11, 2013
First Posted Date  ICMJE November 13, 2013
Last Update Posted Date November 13, 2013
Study Start Date  ICMJE January 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimum Insufflation Capacity in NMD
Official Title  ICMJE Optimum Insufflation Capacity and Peak Cough Flow Augmentation in Patients With Neuromuscular Disease
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Duchenne Muscular Dystrophy
  • Spinal Muscular Atrophy
  • Chronic Respiratory Insufficiency
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Lung Insufflation Volume
    Measurement of the lung volume after hyperinsufflation with positive pressure by IPPB or LIAM
    Interventions:
    • Procedure: IPPB
    • Procedure: LIAM
  • Experimental: Peak Cough Flow
    Measurement of the peak cough flow after hyperinsufflation with positive pressure by IPPB or LIAM
    Interventions:
    • Procedure: IPPB
    • Procedure: LIAM
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2013)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • acute illness
  • history of pneumothorax
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01981915
Other Study ID Numbers  ICMJE OIC2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uwe Mellies, Universität Duisburg-Essen
Study Sponsor  ICMJE Universität Duisburg-Essen
Collaborators  ICMJE Weinmann Geräte für Medizin GmbH + Co. KG
Investigators  ICMJE
Principal Investigator: Uwe Mellies, MD University of Essen, Germany
PRS Account Universität Duisburg-Essen
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP