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Air Stacking vs Glossopharyngeal Breathing in Neuromuscular Diseases

Primary Purpose

Neuromuscular Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glossopharyngeal Breathing
Air Stacking
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Diseases

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Air Stacking

    Glossopharyngeal Breathing

    Arm Description

    Air Stacking was performed with the subject seated in his wheelchair using a manual resuscitation bag (LIFESAVER® model 5345, Hudson, Temecula, USA) connected to a corrugated tube with an internal diameter of 22 mm, a one-way valve and a pipette. The maximum capacity of the bag was 1600 mL. A chest physiotherapist insufflated the patient during the inspiratory phase, requesting that inspire as much air as possible

    Glossopharyngeal Breathing was also performed with the subject seated in his wheelchair and performing successive maneuvers of "swallowing air" until the maximum volume achieve was maintained. Then, the patient was instructed to breathe through ventilometer to register the MIC. Three measurements for each of the techniques were performed, and the highest reading was recorded. A difference of <10% between the measurements was used as the repeatability criterion

    Outcomes

    Primary Outcome Measures

    Vital Capacity
    Vital Capacity is the volume of air expired after a maximal inspiration. The units are mililiters

    Secondary Outcome Measures

    Peak Cough Flow
    The peak cough flow is the maximal flow generated after a cough. The units of measure are Liters per minute

    Full Information

    First Posted
    July 9, 2015
    Last Updated
    July 13, 2015
    Sponsor
    University of Chile
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02500030
    Brief Title
    Air Stacking vs Glossopharyngeal Breathing in Neuromuscular Diseases
    Official Title
    Effects of Air Stacking Versus Glossopharyngeal Breathing on Maximum Insufflation Capacity in Children and Adolescents With Neuromuscular Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    May 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Chile

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuromuscular Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Air Stacking
    Arm Type
    Experimental
    Arm Description
    Air Stacking was performed with the subject seated in his wheelchair using a manual resuscitation bag (LIFESAVER® model 5345, Hudson, Temecula, USA) connected to a corrugated tube with an internal diameter of 22 mm, a one-way valve and a pipette. The maximum capacity of the bag was 1600 mL. A chest physiotherapist insufflated the patient during the inspiratory phase, requesting that inspire as much air as possible
    Arm Title
    Glossopharyngeal Breathing
    Arm Type
    Experimental
    Arm Description
    Glossopharyngeal Breathing was also performed with the subject seated in his wheelchair and performing successive maneuvers of "swallowing air" until the maximum volume achieve was maintained. Then, the patient was instructed to breathe through ventilometer to register the MIC. Three measurements for each of the techniques were performed, and the highest reading was recorded. A difference of <10% between the measurements was used as the repeatability criterion
    Intervention Type
    Procedure
    Intervention Name(s)
    Glossopharyngeal Breathing
    Intervention Description
    Glossopharyngeal Breathing is a type of lung recruitment technique where the patients take a multiple inssuflations with their glossopharyngeal muscle.
    Intervention Type
    Procedure
    Intervention Name(s)
    Air Stacking
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Vital Capacity
    Description
    Vital Capacity is the volume of air expired after a maximal inspiration. The units are mililiters
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    Peak Cough Flow
    Description
    The peak cough flow is the maximal flow generated after a cough. The units of measure are Liters per minute
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Homero Puppo, MSc
    Organizational Affiliation
    University of Chile
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Air Stacking vs Glossopharyngeal Breathing in Neuromuscular Diseases

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