Optimum Insufflation Capacity in NMD

NCT ID: NCT01981915

Last Updated: 2013-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-03-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Lung Insufflation Volume

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

Group Type: EXPERIMENTAL

IPPB

Intervention Type: 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

LIAM

Intervention Type: 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

Peak Cough Flow

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

Group Type: EXPERIMENTAL

IPPB

Intervention Type: 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

LIAM

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

Intermittent Positive Pressure Breathing = IPPB; LIAM = Lung Insufflation Assist Maneuver

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• acute illness
• history of pneumothorax

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weinmann Geräte für Medizin GmbH + Co. KG

INDUSTRY

Sponsor Role: collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role: lead

Responsible Party

Uwe Mellies

Priv.-Doz. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Uwe Mellies, MD

Role: PRINCIPAL_INVESTIGATOR

University of Essen, Germany

Locations

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

Essen, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 16621559 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18716484 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18716483 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 821306 (View on PubMed)

Other Identifiers

OIC2013

Identifier Type: -

Identifier Source: org_study_id