An interventional study of spirometry in Spirometry and Respiratory Function Tests, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Bolivia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-27.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Diagnostic
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.
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.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 350 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single spirometry: only a routine diagnostic test
Diagnostic Test: spirometry
only measurement of spirometry
FEV1
Forced expiratory volume in one second (Liter)
Time frame: measurements done one time at recruitment during spirometry
FVC
forced vital capacity (Liter)
Time frame: measurements done one time at recruitment during spirometry
FEV1/FVC ratio
FEV1/FVC ratio , %
Time frame: measurements done one time at recruitment during spirometry
Standing height
Standing height
Time frame: measurements done one time at recruitment just before spirometry
seated height
seated height
Time frame: measurements done one time at recruitment just before spirometry
Plan to share: Yes — All the parts of the study will be available for reviewing
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: At article submission for reviewing until final acceptation
Access criteria: Following the reviewers' requirements
No publications or documents are linked to this record.
Ran from Jul 2018 to primary completion in Dec 2018, 5 months.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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