Comparison of Minimal Fresh Gas Requirements of Baby EAR and Jackson Rees Anesthetic Circuit
1 other identifier
interventional
20
1 country
1
Brief Summary
The investigators invented the baby enclosed afferent reservoir anesthesia circuit (Baby EAR) which could be used safely in children between 5 and 20 kg, using a fresh gas flow of 2.5 and 3 L/min in the spontaneous breathing and controlled breathing, respectively. There has as yet been no study comparing the minimal fresh gas flow between the Baby EAR and Jackson-Rees anesthesia circuit (JR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 17, 2014
CompletedFirst Posted
Study publicly available on registry
June 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedApril 1, 2015
March 1, 2015
5 months
June 17, 2014
March 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
inspired minimum CO2 (imCO2) > 2 mmHg
All patients were spontaneously ventilated with FGF 500 ml/kg/min at the start of each anesthesia breathing circuit then reduced by 50 ml/kg/min every 5 min, waiting for the imCO2 to be regularly maintained at least 60 sec. The imCO2 values were recorded until rebreathing occurred (imCO2 \> 2 mmHg)
2 hours
Secondary Outcomes (1)
inspired minimum CO2 (imCO2) > 6 mmHg
2 hours
Study Arms (2)
Baby EAR-JR
ACTIVE COMPARATORThe subjects receive Baby EAR circuit from the start until primary and secondary outcomes are achieved. Then the fresh gas flow will be increased to 500 ml/kg/min for 10 minutes before switching to Jackson-Rees (JR) circuit and the procedure will be repeated.
JR-Baby EAR
ACTIVE COMPARATORThe subjects receive Jackson-Rees (JR) circuit from the start until primary and secondary outcomes are achieved. Then the fresh gas flow will be increased to 500 ml/kg/min for 10 minutes before switching to Baby EAR circuit and the procedure will be repeated.
Interventions
A modification of the Enclosed Afferent Reservoir anesthesia circuit (EAR) for pediatric use by adding a KKU one-way valve in the expiratory limb
Eligibility Criteria
You may qualify if:
- weight between 5 and 20 kg
- ASA physical status I or II
- scheduled for general anesthesia
You may not qualify if:
- has respiratory or cardiovascular disease
- can not breathe spontaneously during anesthesia
- for whom the caudal block can not be done
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Study Officials
- PRINCIPAL INVESTIGATOR
Sanchai Theerapongpakdee, MD
Faculty of Medicine, Khon Kaen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
June 17, 2014
First Posted
June 19, 2014
Study Start
May 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
April 1, 2015
Record last verified: 2015-03