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Trial record 36 of 575 for:    CARBON DIOXIDE AND anesthesia

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

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ClinicalTrials.gov Identifier: NCT02167269
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Thepakorn Sathitkarnmanee, Khon Kaen University

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
Anesthesia Device: Baby EAR Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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




Primary Outcome Measures :
  1. inspired minimum CO2 (imCO2) > 2 mmHg [ Time Frame: 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 [ Time Frame: 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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167269


Locations
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Thailand
Srinagarind Hospital
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
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Principal Investigator: Sanchai Theerapongpakdee, MD Faculty of Medicine, Khon Kaen University

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Responsible Party: Thepakorn Sathitkarnmanee, Associate professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT02167269     History of Changes
Other Study ID Numbers: HE531147
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by Thepakorn Sathitkarnmanee, Khon Kaen University:
enclosed afferent reservoir
Jackson Rees system
anesthesia breathing circuit
spontaneous breathing
pediatric anesthesia
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs