Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487169
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-24
Brief Title:
Effectivity Gas Extraction to Prevent Anesthesiologists Waste Gas Exposure of Sevofluorane During Pediatric Induction
Sponsor:
Bnai Zion Medical Center
Organization:
Bnai Zion Medical Center
Study Overview
Official Title:
Effectivity of the Air Extraction to Prevent Anesthesiologists Waste Anesthetic Gas Exposure of Sevoflurane During Pediatric Induction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Inhalational anesthetics IAs are widely used in surgery and experimental research IAs in addition to their medical significance are a major source of chemical contamination in the operating rooms ORsExposure to IAs in ORs personnel results in reproductive effects including infertility spontaneous abortions congenital diseases psychological and neurological disturbances hepatotoxicity and genotoxicity The metabolites of sevoflurane include hexafluoroisopropanol HFIP and inorganic fluoride IF The hospitals engineering department installed an air extractor with the objective to reduce the anesthetic gas concentrations during pediatric anesthesia induction The investigators are interested in checking if the new technique also has an influence in decreasing the level of Sevoflurane breathed in by the anesthesiologistThe investigators purpose is to detect the presence of desfluoroisopropanolol in the urine of ten anesthesiologists who used sevoflurane to induce children with a mask during an eight-hour session in the induction room IR One session will be conducted without the use of the air extractor and the other with the air extractor After 24 hours a urine sample will be taken and sent to the Toxicology Unit
Detailed Description:
IAs are widely used in surgery IAs in addition to their medical significance are a major source of chemical contamination in the ORs dental clinics delivery rooms and intensive care units Although ORs are equipped with ventilation and scavenging systems it should be noted that occupational exposure to IAs is still higher than threshold limit value recommended by Occupational Safety and Health Administration OSHA
Exposure to IAs in ORs personnel results in 1 reproductive effects including 2 infertility 3 spontaneous abortions 4 congenital diseases 5 psychological and neurological disturbances 6 hepatotoxicity 7 and genotoxicity 8
Possible mechanisms underlying the genotoxic effects of these agents are not clear It seems that oxidative stress through excessive production of reactive oxygen species ROS including superoxide hydroxyl and hydrogen peroxide is an important mechanism by which ionizing radiation and IAs cause DNA damage 8
Urinary HFIP has been recently suggested as a valuable biomarker for the monitoring of occupational exposure of medical staff exposed to low concentration of airborne sevoflurane in operating rooms Minimizing the impact of anesthetic gases contributes to the protection of individuals who experience chronic risk of occupational exposure from waste gases in working environments with poor or inadequate scavenging of inhaled anesthetics
To ensure occupational safety around IAs in 1977 the US National Institute for Occupational Safety and Health NIOSH recommended that occupational exposure to halogenated anesthetics agents should not exceed 2 ppm or N2O 25 ppm within a 1-hour period reweighted average for exposure duration To manage and minimize occupational exposure to WAGs NIOSH and others highlight the pivotal importance of using an efficient air ventilation Anesthesia induction specially a performed with needle injection is a stressful part of surgery for pediatric patients and their parents Children may undergo physical mental and physiological distress due to anxiety at the time of induction and after surgery and higher parental anxiety levels are directly associated with childrens preoperative anxiety levels
The parental presence during the use of facial mask to performed the induction with IAs contribute significantly to reduce the anxiety in the childrens
In the Anesthesiology Department of the Bnai Zion Medical Center the induction technique is performed with sevofluorane and Nitrous Oxide gas loaded through a mask and with parenteral presence
This anesthetic approach demands to use the mask to perform the induction therefore it is not adapted closely to the face of the patient during the short period of time when the child is in the excitatory face During this time part of the fresh gas supply leaks to the air of the Pediatric Induction Room PIR This technique obviously increases the concentration of sevoflurane and Nitrous Oxide N2O over the safety recommended standards range
In 2022 measurements in a PIR revealed sevoflurane concentrations far above safety standards of 1 to 2 ppm reaching as high as 334 ppm and measurements of N2O concentrations exceeding safety standards of 25 ppm reaching values as high as 125 ppm
Since the PIR is not equipped with an air extraction system the hospitals engineering department installed an air extractor with the objective to reduce the anesthetic gas concentrations during pediatric anesthesia induction
The investigators checked the levels of sevoflurane in the air of the induction room without the removal of air with sevoflurane and with the removal of air contaminated with sevoflurane
The average sevoflurane concentration recorded without use of the air extractor was Mean 1086 SD 867 significantly exceeded the mean concentration of sevoflurane observed subsequent to the extractor application Mean 018 SD 031 Stimulated by the results obtained in the PIR air we are interested in checking if the new technique also has an influence in decreasing the level of Sevoflurane breathed in by the anesthesiologist
HFIP is a major metabolite of sevoflurane and is excreted in the urine within the first few hours after exposure
The Laboratory of Clinical Toxicology Pharmacology and Pharmacogenetic of the Rambam Health Care Campus has the capability to identifying and quantifying the HFIP in urine using the technique of Mass Spectrometry
The investigators purpose is to detect the presence of HFIP in the urine of ten anesthesiologists who used sevoflurane to induce children with a mask during an eight-hour session in the PIR One session will be conducted without the use of the air extractor and the other with the air extractor After 24 hours a urine sample will be taken and sent to the Toxicology Unit
Exposure to IAs in ORs personnel results in 1 reproductive effects including 2 infertility 3 spontaneous abortions 4 congenital diseases 5 psychological and neurological disturbances 6 hepatotoxicity 7 and genotoxicity 8
Possible mechanisms underlying the genotoxic effects of these agents are not clear It seems that oxidative stress through excessive production of reactive oxygen species ROS including superoxide hydroxyl and hydrogen peroxide is an important mechanism by which ionizing radiation and IAs cause DNA damage 8
Urinary HFIP has been recently suggested as a valuable biomarker for the monitoring of occupational exposure of medical staff exposed to low concentration of airborne sevoflurane in operating rooms Minimizing the impact of anesthetic gases contributes to the protection of individuals who experience chronic risk of occupational exposure from waste gases in working environments with poor or inadequate scavenging of inhaled anesthetics
To ensure occupational safety around IAs in 1977 the US National Institute for Occupational Safety and Health NIOSH recommended that occupational exposure to halogenated anesthetics agents should not exceed 2 ppm or N2O 25 ppm within a 1-hour period reweighted average for exposure duration To manage and minimize occupational exposure to WAGs NIOSH and others highlight the pivotal importance of using an efficient air ventilation Anesthesia induction specially a performed with needle injection is a stressful part of surgery for pediatric patients and their parents Children may undergo physical mental and physiological distress due to anxiety at the time of induction and after surgery and higher parental anxiety levels are directly associated with childrens preoperative anxiety levels
The parental presence during the use of facial mask to performed the induction with IAs contribute significantly to reduce the anxiety in the childrens
In the Anesthesiology Department of the Bnai Zion Medical Center the induction technique is performed with sevofluorane and Nitrous Oxide gas loaded through a mask and with parenteral presence
This anesthetic approach demands to use the mask to perform the induction therefore it is not adapted closely to the face of the patient during the short period of time when the child is in the excitatory face During this time part of the fresh gas supply leaks to the air of the Pediatric Induction Room PIR This technique obviously increases the concentration of sevoflurane and Nitrous Oxide N2O over the safety recommended standards range
In 2022 measurements in a PIR revealed sevoflurane concentrations far above safety standards of 1 to 2 ppm reaching as high as 334 ppm and measurements of N2O concentrations exceeding safety standards of 25 ppm reaching values as high as 125 ppm
Since the PIR is not equipped with an air extraction system the hospitals engineering department installed an air extractor with the objective to reduce the anesthetic gas concentrations during pediatric anesthesia induction
The investigators checked the levels of sevoflurane in the air of the induction room without the removal of air with sevoflurane and with the removal of air contaminated with sevoflurane
The average sevoflurane concentration recorded without use of the air extractor was Mean 1086 SD 867 significantly exceeded the mean concentration of sevoflurane observed subsequent to the extractor application Mean 018 SD 031 Stimulated by the results obtained in the PIR air we are interested in checking if the new technique also has an influence in decreasing the level of Sevoflurane breathed in by the anesthesiologist
HFIP is a major metabolite of sevoflurane and is excreted in the urine within the first few hours after exposure
The Laboratory of Clinical Toxicology Pharmacology and Pharmacogenetic of the Rambam Health Care Campus has the capability to identifying and quantifying the HFIP in urine using the technique of Mass Spectrometry
The investigators purpose is to detect the presence of HFIP in the urine of ten anesthesiologists who used sevoflurane to induce children with a mask during an eight-hour session in the PIR One session will be conducted without the use of the air extractor and the other with the air extractor After 24 hours a urine sample will be taken and sent to the Toxicology Unit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None