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

Morbidly Obese Clinical Trial

Official title:

Use of Breath Stacking Technique on Regional Ventilation in Box Chest in Women With Morbid Obesity: Clinical Trial Controlled and Randominzado

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551277
• Other study ID #: jaqueline 01
• Status: Completed
• Phase: N/A
• First received: March 8, 2012
• Last updated: March 9, 2012
• Start date: March 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2012
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbidly Obese
• Obesity, Morbid

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Cala SJ, Kenyon CM, Ferrigno G, Carnevali P, Aliverti A, Pedotti A, Macklem PT, Rochester DF. Chest wall and lung volume estimation by optical reflectance motion analysis. J Appl Physiol (1985). 1996 Dec;81(6):2680-9. — View Citation

Chlif M, Keochkerian D, Choquet D, Vaidie A, Ahmaidi S. Effects of obesity on breathing pattern, ventilatory neural drive and mechanics. Respir Physiol Neurobiol. 2009 Sep 30;168(3):198-202. doi: 10.1016/j.resp.2009.06.012. Epub 2009 Jun 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest wall regional volume	We considered as primary outcome regional tidal volumes: total current volume of the chest cavity (Vc), changes in tidal volume of pulmonary rib cage (?Vc, ctp), tidal volume variation of the abdominal rib cage (?Vc, CTA) and abdominal tidal volume (?Vc, ab), and secondary outcome Inspiratory capacity (IC).	ten months	Yes

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