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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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29 April 2013 |
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Main ID: |
RBR-33bb7k |
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Date of registration:
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26/01/2012 |
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Primary sponsor: |
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Public title:
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Evaluation of humidity and temperature of inspired gases in pediatric patients under general anesthesia
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Scientific title:
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Evaluation of humidity and temperature of inspired gases in pediatric patients under general anesthesia with different fresh gas flows and use of a heat and moisture exchanger |
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Date of first enrolment:
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18/08/2011 |
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Target sample size:
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40 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-33bb7k/ |
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Study type:
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Study design:
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Clinical trial, with 4 arms, randomized controlled, mono blind
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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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Gustavo
Bicalho |
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Address:
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Rua Alvarenga Peixoto 711/1301
30180120
Belo Horizonte
Brazil |
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Telephone:
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3191339451 |
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Email:
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gpbicalho@gmail.com |
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Affiliation:
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UNESP |
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Name:
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Gustavo
Bicalho |
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Address:
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Rua Alvarenga Peixoto 711/1301
30180120
Belo Horizonte
Brazil |
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Telephone:
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3191339451 |
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Email:
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gpbicalho@gmail.com |
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Affiliation:
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UNESP |
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Key inclusion & exclusion criteria
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Inclusion criteria: ASA physical satus 1 or 2, weight between 10 and 30kg, estimated surgical time of at least 80 minutes
Exclusion criteria: Refusal to participate, head and neck surgery
Age minimum:
1Y
Age maximum:
14Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Humidity and temperature of inspired gases during general anesthesia E03.155.197 G16.500.275.063.725.310 G01.906.595
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Intervention(s)
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The study will have four groups of ten patients each. One intervention will be the modification of the fresh gas flow on the anesthesia station. Two groups will use a fresh gas flow of 1l per minute (low flow) and two groups will use a fresh gas flow of 3l per minute (high flow). The other intervention will be the use of a heat and moisture exchanger (HME) on the ventilatory circuit. Two groups will use the HME and two groups will not. In this way the four groups will be as follow: - Fresh gas flow of 1l/min without HME - Fresh gas flow of 1l/min with HME - Fresh gas flow of 3l/min without HME - Fresh gas flow of 3l/min with HME The recruiting phase and data collection are estimated to take one year.
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Primary Outcome(s)
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It will be measured the temperature (in Celsius degrees) and humidity (in percentage) of the inspired gases. To obtain this measurements it will be used a thermohygrometer adapted on the ventilatory circuit. The outcomes will be the humidity of the inspired gases and temperature of the inspired gases.
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Secondary Outcome(s)
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It will be used as secondary outcomes: the airway pressures, the respiratory frequency of the patient and the patient core temperature
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Secondary ID(s)
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3877-2011
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Source(s) of Monetary Support
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasília, DF, Brazil
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Fundação de Amparo à Pesquisa do Estado de São Paulo - São Paulo , SP, Brazil
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