Spirometric Predicted Values in Bolivia

Overview

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 Title of Study: “Establishment of Spirometric Predicted Values in Bolivia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2018

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 Test: spirometry
    • only measurement of spirometry

Arms, Groups and Cohorts

  • Other: spirometry
    • single spirometry: only a routine diagnostic test

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Standing height
    • Time Frame: measurements done one time at recruitment just before spirometry
    • Standing height
  • seated height
    • Time Frame: measurements done one time at recruitment just before spirometry
    • seated height

Participating in This Clinical Trial

Inclusion Criteria

  • healthy and non-smokers Exclusion Criteria:
  • unhealthy smokers – subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    • Provider of Information About this Clinical Study
      • Principal Investigator: Giuseppe Liistro, Head of clinics – Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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