Spirometric Predicted Values in Bolivia

Establishment of Spirometric Predicted Values in Bolivia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03660111

Acronym

SPIROBOLIVIA

Enrollment

330

Registered

2018-09-06

Start date

2018-07-01

Completion date

2019-01-31

Last updated

2019-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Function Tests, Spirometry

Brief summary

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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTspirometry

only measurement of spirometry

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

subjects will be assigned to their inclusion number

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* healthy and non-smokers

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
FEV1	measurements done one time at recruitment during spirometry	Forced expiratory volume in one second (Liter)
FVC	measurements done one time at recruitment during spirometry	forced vital capacity (Liter)
FEV1/FVC ratio	measurements done one time at recruitment during spirometry	FEV1/FVC ratio , %

Secondary

Measure	Time frame	Description
Standing height	measurements done one time at recruitment just before spirometry	Standing height
seated height	measurements done one time at recruitment just before spirometry	seated height

Countries

Bolivia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026