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Clinical Trials/NCT00997737
NCT00997737
Completed
Phase 1

Diaphragm Mobility During Respiratory Exercises With Incentive Spirometry in Healthy Individuals

Hospital Sirio-Libanes1 site in 1 country17 target enrollmentOctober 2009

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diaphragm Mobility
Sponsor
Hospital Sirio-Libanes
Enrollment
17
Locations
1
Primary Endpoint
ultrasound evaluation of the diaphragm mobility
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
May 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Hospital Sirio-Libanes

Eligibility Criteria

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.

Outcomes

Primary Outcomes

ultrasound evaluation of the diaphragm mobility

Time Frame: six - eight months

Secondary Outcomes

  • pulmonary function test(six - eight months)

Study Sites (1)

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