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Completed

NCT Number: NCT00997737

Diaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing

The objective of the present study is to evaluate diaphragm activity during three breathing exercises: diaphragmatic breathing (DB), flow-oriented (Triflo II)incentive spirometry and volume-oriented (Voldyne) incentive spirometry.

Seventeen healthy subjects will be studied (8 man and 9 woman).

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Instituto de Ensino e Pesquisa do Hospital Sírio Libanês

São Paulo, 01308-050, Brazil

About this study

Right diaphragmatic mobility will be evaluated by determining the craniocaudal displacement of the left branch of the portal vein using a B-mode ultrasound device (Logic 500, Pro Series®; General ElectricMedical Systems, Milwaukee, WI, USA). The ultrasound technician will use a 3.5 MHz convex transducer positioned in the right subcostal region, with the incidence angle perpendicular to the craniocaudal axis, in the direction of the inferior vena cava. Next, an intraparenchymal portal branch will be identified in the field of vision and its position will be traced with the curser during the forced inspiration and expiration. The craniocaudal displacement of these points will be considered to be the amount of right diaphragmatic mobility.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being 18 to 40 years old
  • Having a normal body mass index
  • Being a non-smoker
  • Not knowing the DB and the IS techniques
  • Reporting the absence of respiratory diseases.

Exclusion criteria

  • Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity
  • Inability to understand or perform the procedure.

Treatment and study plan

DB, VI and FI

Device

Two modalities of respiratory exercises based on deep and slow inspirations will be used: DB and IS. During DB, the researcher will place one hand slightly below the lower ribs in the abdominal region of the subject and the subject will be instructed to perform inspirations up to the maximum level of volume avoiding rib cage displacement; this recommendation will also be valid for exercises using incentive spirometers. IS will be executed using two different devices: Triflo II and Voldyne.

Other names: diaphragmatic exercice, incentive spirometry

Primary outcomes

  1. ultrasound evaluation of the diaphragm mobility

    Time frame: six - eight months

Secondary outcomes

  1. pulmonary function test

    Time frame: six - eight months

Sponsors and collaborators

Lead sponsor

Hospital Sirio-Libanes

Other

Registry information

Official study title

Diaphragm Mobility During Respiratory Exercises With Incentive Spirometry in Healthy Individuals

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2009
Registry last updated
May 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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