Neuromuscular DiseasesNCT02500030
Air Stacking vs Glossopharyngeal Breathing in Neuromuscular Diseases
A study testing Glossopharyngeal Breathing and Air Stacking in people with Neuromuscular Diseases, run by University of Chile.
Trial summary
Neuromuscular diseases (NMD) are characterized by a reduced maximum insufflation capacity (MIC), which contributes to increased morbidity and mortality from respiratory diseases. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- Glossopharyngeal Breathing and Air Stacking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of NMD
- Without respiratory exacerbation in the past 30 days
- No prior knowledge of the AS or GPB techniques
- Ability to understand instructions
Who cannot join
- Tracheostomized patients
- Incomplete glottis closure
About this study
Official title: Effects of Air Stacking Versus Glossopharyngeal Breathing on Maximum Insufflation Capacity in Children and Adolescents With Neuromuscular Disease
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.
Read the 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.
- Conditions
- Neuromuscular Diseases
- Being tested
- Glossopharyngeal Breathing, Air Stacking
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glossopharyngeal BreathingProcedure or surgery
Glossopharyngeal Breathing is a type of lung recruitment technique where the patients take a multiple inssuflations with their glossopharyngeal muscle.
Air StackingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Air Stacking | Experimental | 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 Receives: Procedure: Air Stacking |
| Glossopharyngeal Breathing | Experimental | 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 Receives: Procedure: Glossopharyngeal Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital Capacity
Vital Capacity is the volume of air expired after a maximal inspiration. The units are mililiters
Measured: 30 minutes
Secondary outcomes (1)
Peak Cough Flow
The peak cough flow is the maximal flow generated after a cough. The units of measure are Liters per minute
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Torres, University of Chile
- Investigators
- Homero Puppo, MSc, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500030
- Sponsor's protocol ID
- KIN2013-1
- Status last verified
- Jul 2015
- First submitted
- 9 Jul 2015
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Air Stacking Versus Glossopharyngeal Breathing on Maximum Insufflation Capacity in Children and Adolescents With Neuromuscular Disease
- ClinicalTrials.gov ID
- NCT02500030
- Acronym / sponsor ID
- KIN2013-1
- Conditions
- Neuromuscular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air Stacking | Experimental | Procedure: Air StackingAir 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 | Experimental | Procedure: Glossopharyngeal BreathingGlossopharyngeal 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 |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- diagnosis of NMD
- Without respiratory exacerbation in the past 30 days
- No prior knowledge of the AS or GPB techniques
- Ability to understand instructions
Key exclusion criteria (2 listed)
- Tracheostomized patients
- Incomplete glottis closure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glossopharyngeal BreathingGlossopharyngeal Breathing is a type of lung recruitment technique where the patients take a multiple inssuflations with their glossopharyngeal muscle. | Procedure or surgery | Glossopharyngeal Breathing |
| Air StackingAir 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. | Procedure or surgery | Air Stacking |
Primary outcome
Vital Capacity
Time frame: 30 minutes
Vital Capacity is the volume of air expired after a maximal inspiration. The units are mililiters
1 secondary outcome
Peak Cough Flow
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Homero Puppo, MSc principal investigator
University of Chile
Questions about this trial
What is this clinical trial studying?
A study testing Glossopharyngeal Breathing and Air Stacking in people with Neuromuscular Diseases, run by University of Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital Capacity (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.