Comparison of Minimal Fresh Gas Requirements of Baby EAR and Jackson Rees Anesthetic Circuit

Sponsor
Khon Kaen University (Other)
Overall Status
Completed
CT.gov ID
NCT02167269
Collaborator
(none)
20
1
2
5
4

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Baby EAR
N/A

Detailed Description

After intubation, a caudal block with 0.25% bupivacaine with adrenaline :200,000 0.5 to 1 mL/kg was done. Anesthesia was maintained with a 50% N2O/O2 combination with sevoflurane 1 to 3%, adjusted to ensure a proper anesthetic level to achieve normal vital signs and to keep the end-tidal CO2 (ETCO2) <60 mmHg. Fentanyl 1 μg/kg/h was infused during the procedure. All patients were pontaneously ventilated with FGF 500 mL/kg/min at the start of each anesthesia breathing circuit, waiting for the depth of anesthesia to be maintained and the patient to spontaneously breathe for at least 10 minutes. Baseline ETCO2 and imCO2 were then measured. The pulse rate, blood pressure and respiratory rate were recorded every five minutes.

The FGF was reduced by 50 mL/kg/min every five minutes, waiting for the imCO2 to be regularly maintained at least 60 sec. The ETCO2 and imCO2 values were recorded until rebreathing occurred (imCO2 >2 mmHg) and measurements continued until rebreathing was not clinically acceptable (imCO2 >6 mmHg). The minimal FGF before rebreathing occurred (FGF of imCO2 ≤2 mmHg) is the amount of gas that does not cause rebreathing. The minimal FGF for which rebreathing was still acceptable (FGF of imCO2 ≤6 mmHg) is the amount of gas that was clinically acceptable. After switching the anesthesia breathing circuit, the FGF was increased to 500 mL/kg/min for 10 minutes and the procedure was repeated. The minimal FGF before the rebreathing occurred and the FGF at hich rebreathing was still clinically acceptable were recorded. After extubation, all of the patients were observed in the PACU and relevant factors recorded until there was good recovery from anesthesia before sending the patient back to the ward.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Minimal Fresh Gas Requirements of Baby EAR and Jackson Rees Anesthetic Circuit for General Anesthesia in Spontaneously Breathing Children Undergoing Surgery
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Baby EAR-JR

The 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.

Device: Baby EAR
A modification of the Enclosed Afferent Reservoir anesthesia circuit (EAR) for pediatric use by adding a KKU one-way valve in the expiratory limb

Active Comparator: JR-Baby EAR

The 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.

Device: Baby EAR
A modification of the Enclosed Afferent Reservoir anesthesia circuit (EAR) for pediatric use by adding a KKU one-way valve in the expiratory limb

Outcome Measures

Primary Outcome Measures

  1. inspired minimum CO2 (imCO2) > 2 mmHg [2 hours]

    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)

Secondary Outcome Measures

  1. inspired minimum CO2 (imCO2) > 6 mmHg [2 hours]

    All patients were spontaneously ventilated with FGF 500 ml/kg/min at the start of each anesthesia breathing circuit 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 was not clinically acceptable (imCO2 > 6 mmHg).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • weight between 5 and 20 kg

  • ASA physical status I or II

  • scheduled for general anesthesia

Exclusion Criteria:
  • has respiratory or cardiovascular disease

  • can not breathe spontaneously during anesthesia

  • for whom the caudal block can not be done

Contacts and Locations

Locations

Site City State Country Postal Code
1 Srinagarind Hospital Khon Kaen Thailand 40002

Sponsors and Collaborators

  • Khon Kaen University

Investigators

  • Principal Investigator: Sanchai Theerapongpakdee, MD, Faculty of Medicine, Khon Kaen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thepakorn Sathitkarnmanee, Associate professor, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT02167269
Other Study ID Numbers:
  • HE531147
First Posted:
Jun 19, 2014
Last Update Posted:
Apr 1, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Thepakorn Sathitkarnmanee, Associate professor, Khon Kaen University

Study Results

No Results Posted as of Apr 1, 2015