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Optimum Insufflation Capacity in NMD

Primary Purpose

Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Chronic Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
IPPB
LIAM
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Duchenne Muscular Dystrophy focused on measuring Cough augmentation, Peak cough flow, hyperinsufflation

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • acute illness
  • history of pneumothorax

Sites / Locations

  • University of Essen, Children's Hospital, Dep. of Pediatric Pulmonology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lung Insufflation Volume

Peak Cough Flow

Arm Description

Measurement of the lung volume after hyperinsufflation with positive pressure by IPPB or LIAM

Measurement of the peak cough flow after hyperinsufflation with positive pressure by IPPB or LIAM

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 11, 2013
Last Updated
November 5, 2013
Sponsor
Universität Duisburg-Essen
Collaborators
Weinmann Geräte für Medizin GmbH + Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT01981915
Brief Title
Optimum Insufflation Capacity in NMD
Official Title
Optimum Insufflation Capacity and Peak Cough Flow Augmentation in Patients With Neuromuscular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
Collaborators
Weinmann Geräte für Medizin GmbH + Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Chronic Respiratory Insufficiency
Keywords
Cough augmentation, Peak cough flow, hyperinsufflation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lung Insufflation Volume
Arm Type
Experimental
Arm Description
Measurement of the lung volume after hyperinsufflation with positive pressure by IPPB or LIAM
Arm Title
Peak Cough Flow
Arm Type
Experimental
Arm Description
Measurement of the peak cough flow after hyperinsufflation with positive pressure by IPPB or LIAM
Intervention Type
Procedure
Intervention Name(s)
IPPB
Other Intervention Name(s)
Intermittent Positive Pressure Breathing = IPPB
Intervention Description
Lung insufflation with positive pressure using IPPB up from 10 to 40 mbar in 5 mbar increments and consecutive measurement of the insufflation volume
Intervention Type
Procedure
Intervention Name(s)
LIAM
Other Intervention Name(s)
LIAM = Lung Insufflation Assist Maneuver
Intervention Description
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
Primary Outcome Measure Information:
Title
insufflation capacity
Description
Lung volume was measured during spontaneous breathing and after a lung insufflation assist maneuver.
Time Frame
change of lung volume with the procedure; during hospital stay on average 3 days
Secondary Outcome Measure Information:
Title
Peak cough flow
Description
Peak cough flow was measured during spontaneous breathing and after a lung insufflation assist maneuver.
Time Frame
change of peak cough flow with the procedure; during hospital stay on average 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: neuromuscular disorder respiratory insufficiency use of home mechanical ventilation Exclusion Criteria: acute illness history of pneumothorax
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uwe Mellies, MD
Organizational Affiliation
University of Essen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Essen, Children's Hospital, Dep. of Pediatric Pulmonology
City
Essen
State/Province
NRW
ZIP/Postal Code
45122
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16621559
Citation
Dohna-Schwake C, Ragette R, Teschler H, Voit T, Mellies U. Predictors of severe chest infections in pediatric neuromuscular disorders. Neuromuscul Disord. 2006 May;16(5):325-8. doi: 10.1016/j.nmd.2006.02.003. Epub 2006 Apr 18.
Results Reference
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PubMed Identifier
18716484
Citation
Ishikawa Y, Bach JR, Komaroff E, Miura T, Jackson-Parekh R. Cough augmentation in Duchenne muscular dystrophy. Am J Phys Med Rehabil. 2008 Sep;87(9):726-30. doi: 10.1097/PHM.0b013e31817f99a8.
Results Reference
background
PubMed Identifier
18716483
Citation
Bach JR, Mahajan K, Lipa B, Saporito L, Goncalves M, Komaroff E. Lung insufflation capacity in neuromuscular disease. Am J Phys Med Rehabil. 2008 Sep;87(9):720-5. doi: 10.1097/PHM.0b013e31817fb26f.
Results Reference
background
PubMed Identifier
821306
Citation
Hahneberger RW. Applanation tonometry in the conscious cynomolgus monkey (Macaca fascicularis). Acta Ophthalmol (Copenh). 1976 Jul;54(3):311-9. doi: 10.1111/j.1755-3768.1976.tb01260.x.
Results Reference
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Optimum Insufflation Capacity in NMD

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