Spirometric Predicted Values in Bolivia (SPIROBOLIVIA)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Spirometry; Respiratory Function Tests

Treatments: Diagnostic Test: spirometry

Study type: Interventional

Funder types: Other

Identifiers

NCT03660111

SPIROBOLIVIA

Details and patient eligibility

About

There is no local predicted values for spirometry available in Bolivia. The aim of the present study is to establish moderne predicted values for healthy non-smokers recruited in a major city of Bolivia, Santa Cruz De La Sierra.

Full description

There is no local predicted values for spirometry available in Bolivia. To establish the predicted spirometric normal values in Bolivia, 500 healthy men and women, non-smokers will be recruited to perfom spirometry using following the actual ATS/ERS 2005 guidelines.

The spirometer is a Bodybox 5500 (Medisoft, Belgium). The tests will be performed by a highly-trained pneumologist, Dr A. Ajata.

Anthropometric variables recorded: age, sex, weight, standing and sitting height.

Spirometric variables recorded: FEV1, FVC, PEF, FEV6, FEF25,50,75 and MEF Statistical anaysis will be done using R and SPSS softwares. Predicted equations will be compared with existing ones, especially the new GLI-2012 predicted equations.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy and non-smokers

Exclusion criteria

• unhealthy smokers
• subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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330 participants in 1 patient group

spirometry

Other group

Description:

single spirometry: only a routine diagnostic test

Treatment:

Diagnostic Test: spirometry