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NCT05047497 Clinical Trial

Ventilatory Functions, Oxygen Saturation, and Quality of Life Response to Long Time Cement Dust Exposure

Occupational Diseases Clinical Trial

Official title:
Ventilatory Functions, Oxygen Saturation, and Quality of Life Response to Long Time Cement Dust Exposure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05047497
Other study ID # Cairo
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date May 29, 2019

Study information
Verified date September 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Thousands of people are working daily in a dusty environment. Many studied reported respiratory symptoms and ventilatory disorders among Factory workers who exposed to cement dust. But the evidence for respiratory effect and daily activities over a long time of cement dust exposure has not been conclusive

Description:

A total of 49 subjects working in a cement production factory were assessed and divided into three groups according to the total period of work exposure. Groupe A (18 subjects) with work period < 10 years, group B (13 subjects) with work period 10-15 years, group C (18 subjects) with work period > 15 years. The ventilatory functions, oxygen saturation, and quality of life were assessed in the three groups. RESULTS: The study results revealed a statistically significant difference between the three groups in the mean values of FVC (%), FEV1/FVC (%), SPO2.

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date May 29, 2019
Est. primary completion date March 5, 2019
Accepts healthy volunteers
Gender Male
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria: - The ages were between 25 to 50 years old. - the body mass index ranged from (18,5 - 29,9) kg/m2. Exclusion Criteria: - Age less than 25 or more 50. - Any chronic diseases - severe musculoskeletal and cardiopulmonary disorders and - Class III Obesity (35-39.9 kg/m 2) or more

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• questionaire and ventilatory function test
we assessed the arterial blood gases and the ventilatory functions and quality of life of whole three groups

Locations
Country Name City State
Egypt faculty of physical therapy Cairo university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary The ventilatory functions ventilatory function tests were used to assess FVC (%), FEV1/FVC (%),PEF (%), FEV1 (%) 8 months
Primary oxygen saturation measuring oxygen saturation using SPo2 8 months
Primary quality of life were assessed the mean values of the physical functioning item and energy/fatigue item in the quality of life questionnaire 8 months
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