Optimum Insufflation Capacity in NMD

Duchenne Muscular Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981915
• Other study ID #: OIC2013
• Status: Completed
• Phase: N/A
• First received: October 11, 2013
• Last updated: November 5, 2013
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: November 2013
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• neuromuscular disorder

• respiratory insufficiency

• use of home mechanical ventilation

Exclusion Criteria:

• acute illness

• history of pneumothorax

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Respiratory Insufficiency
• Duchenne Muscular Dystrophy
• Muscular Atrophy
• Muscular Atrophy, Spinal
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Spinal Muscular Atrophy

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	University of Essen, Children`s Hospital, Dep. of Pediatric Pulmonology	Essen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Universität Duisburg-Essen	Weinmann Geräte für Medizin GmbH + Co. KG

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View 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. Epub 2006 Apr 18. — View Citation

Hahneberger RW. Applanation tonometry in the conscious cynomolgus monkey (Macaca fascicularis). Acta Ophthalmol (Copenh). 1976 Jul;54(3):311-9. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insufflation capacity	Lung volume was measured during spontaneous breathing and after a lung insufflation assist maneuver.	change of lung volume with the procedure; during hospital stay on average 3 days	No
Secondary	Peak cough flow	Peak cough flow was measured during spontaneous breathing and after a lung insufflation assist maneuver.	change of peak cough flow with the procedure; during hospital stay on average 3 days	No