Air Stacking vs Glossopharyngeal Breathing in Neuromuscular Diseases

Neuromuscular Diseases Clinical Trial

Official title:

Effects of Air Stacking Versus Glossopharyngeal Breathing on Maximum Insufflation Capacity in Children and Adolescents With Neuromuscular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500030
• Other study ID #: KIN2013-1
• Status: Completed
• Phase: N/A
• First received: July 9, 2015
• Last updated: July 13, 2015
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comité de Bioética
• Study type: Interventional

Clinical Trial Summary

Neuromuscular diseases (NMD) are characterized by a reduced maximum insufflation capacity (MIC), which contributes to increased morbidity and mortality from respiratory diseases. Techniques such as glossopharyngeal breathing (GPB) and insufflation using a manual resuscitation bag, or "air stacking (AS)", can be used to increase the MIC. These techniques employ different mechanisms, and the ability to learn the technique plays a key role in its proper implementation and effectiveness. The objective is compare the effects of AS and GPB on the MIC in patients with NMD.

Children and adolescents with NMD who were users of non-invasive mechanical ventilation were recruited. Vital capacity (VC) and MIC were measured prior to and after the intervention with AS and GPB. Values were compared pre- and post-intervention and were considered statistically significant if p <0.05.

Description:

In neuromuscular diseases (NMD), progressive weakness of the respiratory muscles causes changes in the cough mechanism and prevents the elimination of secretions, which is the main cause of morbidity and mortality in this population.

Improving the cough response and achieving effective secretion elimination is required to increase lung volume and optimize the peak cough flow (PCF). It has been shown that a high PCF decreases respiratory complications in NMD. Vital capacity (VC) and maximum insufflation capacity (MIC) are the most important factors in increasing the PCF and, consequently, obtaining a more effective cough; thus, optimizing the lung volumes to achieve an adequate cough flow is important for effective bronchial hygiene. Currently, manual techniques are used to increase the MIC to achieve an effective PCF.

The most important manual techniques used to improve the MIC and, consequently the PCF, are air stacking (AS) and glossopharyngeal breathing (GPB). These have the advantages of low cost, patient autonomy and relative ease of learning compared to other techniques using electromechanical devices (e.g., volumetric ventilators and mechanical cough assist devices), whose main disadvantages are the high cost and complexity of use. AS involves delivering multiple breaths into a manual resuscitation bag and holding the insufflation volumes with the momentary closure of the glottis, which is repeated until the MIC is reached. GPB uses the glossopharyngeal muscles to successively introduce small amounts of air into the lungs to induce coughing and assist the weak inspiratory muscles. These techniques have been useful in treating different NMD, such as Spinal Muscular Atrophy (SMA) Type II, Duchenne Muscular Dystrophy (DMD) and Spinal Cord Injury (SCI).

The aim of this study was to compare the effects of two low-cost techniques, AS and GPB, on the MIC in children and adolescents with NMD. The hypothesis of this investigation was that although both techniques are effective, using AS results in a higher MIC than GPB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• diagnosis of NMD

• Without respiratory exacerbation in the past 30 days

• No prior knowledge of the AS or GPB techniques

• Ability to understand instructions

Exclusion Criteria:

• Tracheostomized patients

• Incomplete glottis closure

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Procedure:
• Glossopharyngeal Breathing
Glossopharyngeal Breathing is a type of lung recruitment technique where the patients take a multiple inssuflations with their glossopharyngeal muscle.
• Air Stacking
Air Stacking is a type of lung volume recruitment technique where insufflations are stacked in the lungs to maximally expand them, here done with a manual resuscitator.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital Capacity	Vital Capacity is the volume of air expired after a maximal inspiration. The units are mililiters	30 minutes	Yes
Secondary	Peak Cough Flow	The peak cough flow is the maximal flow generated after a cough. The units of measure are Liters per minute	30 minutes	Yes