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The sevoflurane concentrations (as well as vital signs, child's date of birth, type of surgery) will be recorded during the first 10 minutes of anesthesia.
Protocol definition:
This study will not deviate from standard anesthetic management of children with the exception of recording the child's vital signs and anesthetic gas concentrations during the anesthetic induction.
Healthy children, 2-6 years of age, fasting and unmedicated scheduled to undergo minor elective surgery under general anesthesia at Oishei Children's Hospital in Buffalo, New York will be consented for this protocol by the principal investigator. Parents who speak English will be approached for consent; the formal hospital translator service will be used for those parents who do not speak English. The medical translator will translate the consent form for the parents.
Children will be selected for inclusion in this study from the elective surgery list. A total of 28 children of both sexes will be enrolled, 14 with each of the two workstations. We will strive to include the workstation in each operating room at least once in the study. The choice of anesthesia workstations, Drager Apollo or General Electric (GE) Ohmeda, is predetermined by the floor on which the surgery is planned. Drager Apollo workstations are deployed in each of the 7 pediatric operating rooms on the second floor at Oishei and GE Ohmeda workstations are deployed in each of the 5 pediatric operating rooms on the third floor at Oishei.
Once the standard anesthesia monitors are applied, the children will undergo a routine inhalational induction that begins with a mixture of 5 liters/minute nitrous oxide and 2 liters/minute oxygen. Once the end-tidal nitrous oxide concentration reaches 0.45, the sevoflurane vaporizer will be dialed to 8%. The inspired and expired concentrations of sevoflurane will be recorded at the designated times (see data collection sheet) for the first 10 minutes of anesthesia. All vital signs (oxygen saturation, end-tidal carbon dioxide tension, blood pressure and heart rate) will also be recorded.All unusual movements and airway responses will also be recorded and when they occurred (under Notes on the data collection form). At the conclusion of the 10 minutes of the induction, the airway will be secured with an airway device, the surgery will proceed as planned and the recording will cease. The study will be terminated.
The inspired and expired concentrations of Sevoflurane with the Drager Apollo and GE Ohmeda workstations over time will be summarized and displayed graphically. The maximum inspired concentrations of Sevoflurane during each induction with the two types of workstations will be compared using Student's t-test at a significance level of P<0.05.
Jerrold Lerman MD, FRCPC, FANZCA (Fellow of the Australian and New Zealand College of Anesthetists) July 11, 2024
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control is GE Ohmeda workstation | The washin of sevoflurane in the GE Ohmeda workstation during induction of anesthesia. |
| |
| Intervention is Drager Apollo workstation | The washin of sevoflurane in the Drager Apollo workstation during induction of anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The washin of sevoflurane in the GE Ohmeda workstation | Drug | The increases in the end-tidal to inspired sevoflurane concentrations during induction of anesthesia with the Drager Apollo compared with the GE Ohmeda workstations |
| Measure | Description | Time Frame |
|---|---|---|
| Ratios of the Inspired to Expired Sevoflurane Concentrations During Induction of Anesthesia | We will measure the inspired and expired sevoflurane concentrations using an agent monitor, determine the ratio for each patient during each measurement at 30 seconds for the first 5 minutes of induction and and then every minute until the IV is secured. Data are reported as means and standard deviations at each of the time points and represented in a figure. | From 0 to 10 minutes of induction of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Inspired Concentration at 1 Minute of Induction | The maximum percent sevoflurane measured at 1 minute of induction of anesthesia will be summarized as means and standard deviation for each workstation. | At 1 minute during induction of anesthesia |
| Maximum Sevoflurane Concentrations During Induction of Anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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Children scheduled for ambulatory surgery at Oishei Children's Hospital in Buffalo on both the second and third floors of the hospital
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| Name | Affiliation | Role |
|---|---|---|
| Jerrold Lerman, MD, FRCPC | Great lakes anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John R. Oishei Children's Hospital | Buffalo | New York | 14203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40178391 | Derived | Lerman J, Correa AMR. Sevoflurane Washin With the Drager Apollo and GE Datex Ohmeda Aisys Workstations in Healthy Children. Paediatr Anaesth. 2025 Jul;35(7):535-541. doi: 10.1111/pan.15106. Epub 2025 Apr 3. |
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I am not interested in sharing the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control is GE Ohmeda Workstation | The washin of sevoflurane in the GE Ohmeda workstation during induction of anesthesia. The washin of sevoflurane: The increases in the end-tidal to inspired sevoflurane concentrations during induction of anesthesia with the Drager Apollo compared with the GE Ohmeda workstations |
| FG001 | Intervention is Drager Apollo Workstation | The washin of sevoflurane in the Drager Apollo workstation during induction of anesthesia. The washin of sevoflurane: The increases in the sevoflurane concentrations during induction of anesthesia with the Drager Apollo compared with the GE Ohmeda workstations |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All children irrespective of sex, race and ethnicity were enrolled. All children were required to be 2 to <7 years of age.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control is GE Ohmeda Workstation | The washin of sevoflurane in the GE Ohmeda workstation during induction of anesthesia. The washin of sevoflurane: The increases in the end-tidal to inspired sevoflurane concentrations during induction of anesthesia with the Drager Apollo compared with the GE Ohmeda workstations |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ratios of the Inspired to Expired Sevoflurane Concentrations During Induction of Anesthesia | We will measure the inspired and expired sevoflurane concentrations using an agent monitor, determine the ratio for each patient during each measurement at 30 seconds for the first 5 minutes of induction and and then every minute until the IV is secured. Data are reported as means and standard deviations at each of the time points and represented in a figure. | Table of the inspired to expired sevoflurane concentration ratios for the GE Ohmeda and Drager Apollo workstations during the first 10 minutes. Analysis was by two-factor repeated measures ANOVA and the Sidak test for multiple comparisons. | Posted | Mean | Standard Deviation | ratio | From 0 to 10 minutes of induction of anesthesia |
|
10 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control is GE Ohmeda Workstation | The washin of sevoflurane in the GE Ohmeda workstation during induction of anesthesia. The washin of sevoflurane: The increases in the sevoflurane concentrations during induction of anesthesia with the Drager Apollo compared with the GE Ohmeda workstations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerrold Lerman | Great Lakes Anesthesiology | 7163236570 | jlerman@rogers.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2024 | Mar 26, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 20, 2024 | Mar 26, 2025 | ICF_001.pdf |
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|
The maximum sevoflurane concentrations (inspired and expired) during the first 10 minutes of induction of anesthesia |
| 10 minutes of induction of anesthesia |
| Time to Reach 90% of the Maximum Inspired Concentration | The time (minutes) to reach 90% of the maximum inspired sevoflurane concentration during induction of anesthesia. | within the first 10 minutes of induction of sevoflurane |
| Intervention is Drager Apollo Workstation |
The washin of sevoflurane in the Drager Apollo workstation during induction of anesthesia. The washin of sevoflurane: The increases in the sevoflurane concentrations during induction of anesthesia with the Drager Apollo compared with the GE Ohmeda workstations |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Gender not collected - irrelevant for this study. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Ratio of alveolar to inspired sevoflurane concentrations | Ratio of end-tidal to inspired concentrations of sevoflurane at baseline are ZERO | Mean | Standard Deviation | ratio |
|
| OG001 | Intervention is Drager Apollo Workstation | The washin of sevoflurane in the Drager Apollo workstation during induction of anesthesia. The washin of sevoflurane: The increases in the sevoflurane concentrations during induction of anesthesia with the Drager Apollo compared with the GE Ohmeda workstations |
|
|
| Secondary | Maximum Inspired Concentration at 1 Minute of Induction | The maximum percent sevoflurane measured at 1 minute of induction of anesthesia will be summarized as means and standard deviation for each workstation. | Student's t test | Posted | Mean | Standard Deviation | percent sevoflurane | At 1 minute during induction of anesthesia |
|
|
|
| Secondary | Maximum Sevoflurane Concentrations During Induction of Anesthesia | The maximum sevoflurane concentrations (inspired and expired) during the first 10 minutes of induction of anesthesia | Posted | Mean | Standard Deviation | percentage of sevoflurane | 10 minutes of induction of anesthesia |
|
|
|
| Secondary | Time to Reach 90% of the Maximum Inspired Concentration | The time (minutes) to reach 90% of the maximum inspired sevoflurane concentration during induction of anesthesia. | Posted | Median | Inter-Quartile Range | minutes | within the first 10 minutes of induction of sevoflurane |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Intervention is Drager Apollo Workstation | The washin of sevoflurane in the Drager Apollo workstation during induction of anesthesia. The washin of sevoflurane: The increases in the sevoflurane concentrations during induction of anesthesia with the Drager Apollo compared with the GE Ohmeda workstations | 0 | 12 | 0 | 12 | 0 | 12 |
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