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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.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-33bb7k
Date of registration: 26/01/2012
Primary sponsor: Universidade Estadual Paulista - Botucatu, SP, Brazil
Public title: Evaluation of humidity and temperature of inspired gases in pediatric patients under general anesthesia
Scientific title: 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
Date of first enrolment: 18/08/2011
Target sample size: 40
Recruitment status: recruiting
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-33bb7k/
Study type: 
Study design:  Clinical trial, with 4 arms, randomized controlled, mono blind  
Countries of recruitment
Brazil
Contacts
Name: Gustavo  Bicalho
Address:  Rua Alvarenga Peixoto 711/1301 30180120 Belo Horizonte Brazil
Telephone: 3191339451
Email: gpbicalho@gmail.com
Affiliation:  UNESP
Name: Gustavo  Bicalho
Address:  Rua Alvarenga Peixoto 711/1301 30180120 Belo Horizonte Brazil
Telephone: 3191339451
Email: gpbicalho@gmail.com
Affiliation:  UNESP
Key inclusion & exclusion criteria
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: -
Health Condition(s) or Problem(s) studied
Humidity and temperature of inspired gases during general anesthesia
E03.155.197
G16.500.275.063.725.310
G01.906.595
Intervention(s)
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.
Primary Outcome(s)
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.
Secondary Outcome(s)
It will be used as secondary outcomes: the airway pressures, the respiratory frequency of the patient and the patient core temperature
Secondary ID(s)
3877-2011
Source(s) of Monetary Support
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasília, DF, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo - São Paulo , SP, Brazil
Secondary Sponsor(s)
Fundação de Amparo à Pesquisa do Estado de São Paulo - São Paulo , SP, Brazil
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