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

March 30, 2015 updated by: Thepakorn Sathitkarnmanee, Khon Kaen University

Comparison of Minimal Fresh Gas Requirements of Baby EAR and Jackson Rees Anesthetic Circuit for General Anesthesia in Spontaneously Breathing Children Undergoing Surgery

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Khon Kaen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sanchai Theerapongpakdee, MD, Faculty of Medicine, Khon Kaen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HE531147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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