Use of Breath Stacking Technique on Regional Ventilation in Box Chest in Women With Morbid Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniella Cunha Brandao, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT01551277
First received: March 8, 2012
Last updated: March 9, 2012
Last verified: March 2012

March 8, 2012
March 9, 2012
March 2010
December 2010   (final data collection date for primary outcome measure)
Chest wall regional volume [ Time Frame: ten months ] [ Designated as safety issue: Yes ]
We considered as primary outcome regional tidal volumes: total current volume of the chest cavity (Vc), changes in tidal volume of pulmonary rib cage (ΔVc, ctp), tidal volume variation of the abdominal rib cage (ΔVc, CTA) and abdominal tidal volume (ΔVc, ab), and secondary outcome Inspiratory capacity (IC).
Same as current
Complete list of historical versions of study NCT01551277 on ClinicalTrials.gov Archive Site
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Use of Breath Stacking Technique on Regional Ventilation in Box Chest in Women With Morbid Obesity
Use of Breath Stacking Technique on Regional Ventilation in Box Chest in Women With Morbid Obesity: Clinical Trial Controlled and Randominzado

Objectives: To evaluate the effects of the technique of Breath Stacking (BS) in the distribution of ventilation in the chest in women with morbid obesity. Methods: Randomized clinical trial, blinded, and controlled with 32 women (BMI ≥ 40kg/m2), separated into two groups: control (GC) with n = 16 and 41.94 ± 9.38 years and group Breath Stacking (GBS) , n = 16 and 40.38 ± 10.16 years. Optoelectronic plethysmography (POE) was used to assess lung ventilation. For the BS technique was used to mask the expiratory branch occluded and Wright spirometer. GBS held three techniques with an interval of three minutes. The GC used the same circuit without the occlusion of the expiratory branch. Results: GBS was found to be higher in the contribution of tidal volume (VT) into the chest circumference (p = 0.04) and decrease in abdominal compartment (p = 0.03), whereas the CG showed no difference in distribution. Spirometric variables: FEV1 (%), FVC (%), FEV1/FVC (%), VC and CI showed no difference before and after the technical BS and GBS in the GC. Conclusions: The technique BS altered the distribution pattern of regional ventilation, resulting in greater contribution in lung volume in the lower rib cage, corresponding to activity of the diaphragm, with redistribution of volume between compartments.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Morbidly Obese
  • Other: Placebo-BREATH STACKING
    The control group used the same circuit in the intervention group, but without occlusion of the expiratory branch and followed the same protocol to capture the images, ie, basal respiration for five minutes, then three periods of breathing through the mask, the equivalent time the period of technical BS, and five minutes of respiration. The volunteers were instructed to maintain respiration during the period they were using the mask.
  • Other: BREATH STACKING
    In the intervention group used a silicon mask, involving the nose and mouth with two outputs, one containing the Wright spirometer MARK 8 analog output and the other was occluded. It was explained that the mask would only allow the air entering during inspiration, and that should inspire the volunteer gradually filling the lungs with air until you feel that completely filled with an average time of 20 seconds, as shown in figure 1 obtained during the method of BS. The end of the technique would be in two situations: when the volunteer asked for it through a hand gesture, or when prearranged by Wright spirometer, was observed by the researcher that there was no change in the inspired volume.
  • Placebo Comparator: Control Group
    Intervention: Other: Placebo-BREATH STACKING
  • Experimental: BREATH STACKING
    Intervention: Other: BREATH STACKING

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women aged 19-60 years
  • BMI ≥ 40 kg/m2

Exclusion Criteria:

  • Women with chronic lung disease
  • Smokers
  • Neuromuscular disease
  • Disability in performing the procedures
Female
19 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01551277
jaqueline 01
Yes
Daniella Cunha Brandao, Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
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Universidade Federal de Pernambuco
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP