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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
RBR-9vc722 |
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Date of registration:
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30/05/2012 |
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Primary sponsor: |
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Public title:
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The interference of the nail polish on oxygenation in patients with lung disease in exercise.
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Scientific title:
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Evaluation of interference of finger nail polish on peripheral oxygen saturation in patients with pulmonary disease at rest and during exercise.
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Date of first enrolment:
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01/10/2011 |
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Target sample size:
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42 |
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Recruitment status: |
recruitment completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-9vc722/ |
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Study type:
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Intervention |
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Study design:
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Diagnostic, single group, open, single arm clinical trial.
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Walkiria
Bittencourt |
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Address:
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Rua Napoleão de Barros, 754 - Vila Clementino
04024-002
São Paulo
Brazil |
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Telephone:
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11 5576 4430 |
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Email:
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wshimoya@yahoo.com.br |
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Affiliation:
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Universidade Federal de São Paulo |
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Name:
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Walkiria
Bittencourt |
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Address:
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Rua Napoleão de Barros, 754 - Vila Clementino
04024-002
São Paulo
Brazil |
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Telephone:
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11 5576 4430 |
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Email:
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wshimoya@yahoo.com.br |
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Affiliation:
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Universidade Federal de São Paulo |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with stable chronic obstructive pulmonary disease (COPD);
Current non-smokers;
Both sexes;
Exclusion criteria: Heart disease (heart failure, arrhythmia); Musculoskeletal disease;
Scleroderma;
Onychomycosis;
Hemoglobin (Hb) less than 13.5 g / dl for men and 12,0g/dl for women, or greater than 17.5 g / dl for men and 16.5 g / dl for women;
Hematocrit (Hct) less than 40.5% for men and 36.0% for women or greater than 52.0 % for men and 48% for women;
Bilirubin less than 0.4 mg / dl or greater than 1.2 mg / dl for both sexes;
Sistemic arterial hypertension;
Abnormal peripheral perfusion with Capillary refill > 3s;
Carbon monoxide levels (CO) equal to or greater than 10ppm.
Age minimum:
18
Age maximum:
80
Gender:
-
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Health Condition(s) or Problem(s) studied
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chronic obstructive pulmonary disease, peripheral oxygen saturation.
C08.381.495.389
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Intervention(s)
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The study included 42 patients with chronic obstructive pulmonary disease (COPD). In the same patient, was used four colors of nail polish (base, light pink, red and brown) randomly distributed on the fingers of his right hand, as control of the hand contralateral fingers of the same patient. The oxygen saturation was measured at rest with and without enamel and during the 4th, 5th and 6th minute of exercise. Data collection was performed only once in each patient and in the period 2007 to 2009.
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Primary Outcome(s)
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Values of peripheral oxygen saturation above 90% measured by pulse oximetry once
at rest before and after nail polish and once during exercise.
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Secondary Outcome(s)
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Values of oxygen saturation expected after the use of nail polish assessed during the fourth, fifth and sixth minutes of exerciseless than 90%.
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Secondary ID(s)
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CEP1794/07
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nº 372/CEP-HUJM07
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Source(s) of Monetary Support
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Universidade Federal de São Paulo - São Paulo, SP, Brazil
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