Optimum Insufflation Capacity in NMD

NCT01981915 | Completed

• 1 other identifier: OIC2013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Duchenne Muscular Dystrophy; Spinal Muscular Atrophy; Chronic Respiratory Insufficiency

Keywords

Cough augmentation; Peak cough flow; hyperinsufflation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Peak cough flow

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

Study Arms (2)

Lung Insufflation Volume

EXPERIMENTAL

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

Procedure: IPPB; Procedure: LIAM

Peak Cough Flow

EXPERIMENTAL

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

Procedure: IPPB; Procedure: LIAM

Interventions

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

Also known as: Intermittent Positive Pressure Breathing = IPPB

Lung Insufflation Volume; Peak Cough Flow

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

Also known as: LIAM = Lung Insufflation Assist Maneuver

Lung Insufflation Volume; Peak Cough Flow

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• acute illness
• history of pneumothorax

Sponsors & Collaborators

• Universität Duisburg-Essen: lead
• Weinmann Geräte für Medizin GmbH + Co. KG: collaborator

Study Sites (1)

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

Essen, North Rhine-Westphalia, 45122, Germany

Location

Related Publications (4)

• 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.

  PMID: 16621559 BACKGROUND

• 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.

  PMID: 18716484 BACKGROUND

• 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.

  PMID: 18716483 BACKGROUND

• 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.

  PMID: 821306 BACKGROUND

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Muscular Atrophy, Spinal

Interventions

Intermittent Positive-Pressure Breathing

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Uwe Mellies, MD

  University of Essen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.-Doz. Dr. med.

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: November 13, 2013
• Study Start: January 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

DE (1)