Air Stacking vs Glossopharyngeal Breathing in Neuromuscular Diseases

NCT02500030 | Completed DMC

• 1 other identifier: KIN2013-1
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (1)

• Vital Capacity

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

  30 minutes

Secondary Outcomes (1)

• Peak Cough Flow

  30 minutes

Study Arms (2)

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

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

Procedure: Glossopharyngeal Breathing

Interventions

Glossopharyngeal Breathing PROCEDURE

Glossopharyngeal Breathing is a type of lung recruitment technique where the patients take a multiple inssuflations with their glossopharyngeal muscle.

Glossopharyngeal Breathing

Air Stacking PROCEDURE

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.

Air Stacking

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosis of NMD
• Without respiratory exacerbation in the past 30 days
• No prior knowledge of the AS or GPB techniques
• Ability to understand instructions

You may not qualify if:

• Tracheostomized patients
• Incomplete glottis closure

Sponsors & Collaborators

• University of Chile: lead

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Homero Puppo, MSc

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rodrigo Torres-Castro

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 16, 2015
• Study Start: June 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 16, 2015

Record last verified: 2015-07