Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476353
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief Title:
Syringe Pressure Analysis A Critical Examination of the Operators Burden
Sponsor:
Orthospine Advance Health Inc
Organization:
Orthospine Advance Health Inc
Study Overview
Official Title:
Comparative Analysis of Force and Pressure Requirements Across Different Syringe Sizes for Pain Management Procedures A Randomized Prospective in Vivo Trial
Status:
COMPLETED
Status Verified Date:
2024-06
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:
This was a randomized prospective clinical trial conducted from October 1 2023 to May 15 2024 at the University Surgery Center in Merced CA The project was approved by the MetroWest Medical Center Institutional Review Board IRB Patients in each procedure group were categorized into groups and randomly distributed into four sub-groups based on the syringe size used 5ml 10ml 20ml 30ml A medical grade force sensor device was used to collect the necessary real-time syringe force data An analysis of variance ANOVA and pairwise t test were used to make comparisons between means and determine statistical significance
Detailed Description:
This was a randomized prospective double-blind clinical trial conducted from October 1 2023 to May 15 2024 at the University Surgery Center in Merced CA The project was approved by the MetroWest Medical Center Institutional Review Board IRB 2023-100 Subject confidentiality and privacy were protected according to the Health Insurance Portability and Accountability Act HIPAA The research study included all voluntary patients undergoing pain management procedures from October 1 2023 to May 15 2024 Patients were asked about their interest in voluntarily participating in the research study Interested patients were taken to another conference room by research staff where the study was explained in detail and they were given written information with enough time to consider the alternatives risks and benefits of participating in the research project
Patients requiring more time to sign the informed consent or needing additional time to read the information or ask questions about the study were offered more time to decide from registration until they reached the preoperative area In the preoperative area research staff asked patients to confirm their decision to participate in the research project and addressed any further questions Patients were given written information in English or Spanish including a short form with an attestation in lay-person terminology regarding the research project and questions clarification Basic information about the data collected and HIPAA privacy was also provided Patients were asked to sign informed consent for enrollment into the study All procedures were performed by one orthopedic spine surgeon Dr Gabriel Garcia-Diaz who conducted all spinal pain injections for pain management procedures at the University Surgery Center Merced CA Data was collected by Ahmadzakaria Arjmand Ahmed Zabiba and Ahmadzaki Arjmand
Patients with cervical thoracic and lumbosacral pain from a single surgical practice OrthoSpine Advance Health Inc were enrolled Procedures were performed at the outpatient University Surgery Outpatient Center Patients were initially assessed by a single orthopedic spine surgeon with more than ten years of experience performing pain management procedures and over 12000 interventional pain injections The patients procedures were ambulatory with patients fasting off blood thinners and under monitored anesthesia care MAC by a licensed anesthesiologist or certified CRNA followed up one week after the procedure
All patients undergoing procedures from October 1 2023 to May 15 2024 were asked about their interest in participating in the research study Interested patients were taken to another conference room by research staff where the study was explained in detail and they were given enough time to consider the alternatives risks and benefits of participation If patients needed more time to read the information or ask more questions they were offered additional time to decide from registration until they reached the preoperative area In the preoperative area patients were asked by research staff to confirm their decision to participate in the research project and address any remaining questions After deciding to participate patients were assigned a User ID which was added to the assigned official injection list from the University Surgery Center for cross-reference This process ensured that only participating patients with User IDs were included in the official procedure list without identifying patient information in the general data collection sheet
After assigning the User ID patients were stratified based on the procedure to be performed Patients were categorized into groups depending on the procedure Category I for sacroiliac joint blocks Category II for transforaminal injection blocks T-thoracic L-lumbar Category III for medial branch blocks C-cervical T-thoracic L-lumbar and Category IV for radiofrequency ablation C-cervical T-thoracic L-lumbar Each category was randomly distributed into four cohort groups A B C D for each syringe size 5ml 10ml 20ml 30ml The syringes and needles used during the procedures were manufactured by BD McKesson or Stryker Table 1
For all patients undergoing injections basic preoperative labs were collected CBC and differential PT PTT INR and urinalysis
The study employed a novel method for measuring the force required to inject medications using different syringe sizes A forcesensor plunger complex was attached to the syringe for real-time force data analysis This device did not come in direct contact with patients and was enclosed in a sterile field minimizing the risk of contamination The forcesensor plunger complex was the safest proposed model designed for humans to be attached to the syringe for real-time force data analysis It did not come in direct contact with the patient and was used at the outside distal end of the syringe plunger enclosed in a sterile field only to collect data for real-time syringe force drug delivery As such it was a Class 1 medical device that did not pose a reasonable risk for illness or injury to the patient The device was only used for clinical design controltrial and not for regularcommon use
There was minimal risk of contamination or any change in the standard of care for the treatment offered besides collecting real-time peak force data analysis The forcesensor plunger complex did not interfere with the handle of the syringe and the monitor was located more than three feet away from the patient The sterile enclosure field was created at the forcesensor plunger complex isolating it from the patient and maintaining the sterile surgical field with non-significant risk of contamination
The forcesensor plunger complex did not perform change or interact with anything except to record the force exerted by the physician It did not interfere with the flow time or location of medicine insertion in the body All parameters were under the control of the physician as usual The equipment was cleaned and sanitized according to approved surgical cleaning and sanitizing agents The entire cart with contents was wiped down and the wheels were sprayed with 70 IPA before entering the operating room Dedicated equipment carts were routinely cleaned and sanitized All equipment used in the forcesensor plunger complex was sanitized using sterile IPA wipes The forcesensor plunger complex model was validated in a cadaver model in 2019 and with a control group at UC Merced in 2023 before requesting permission and approval for data collection There was no change in the procedure or equipment used for the proposed model
Based on the information a request was made for IRB board allowance of the use of the forcesensor plunger professional medical grade equipment to collect the necessary syringe real-time force data analysis required and exempt it from complying with the requirements as Medical Device Class I or for a 510k submission If the forcesensor plunger complex was considered a medical device it should require FDA Medical Class 1 General Controls established in 21CFR part 801 803 and 807 and a 510 K exemption should be requested For data collection there was minimal to zero risk to the patient and minimal risk of contaminating the sterile field The study was performed for the first time in humans after validation in cadavers demonstrating the model provided non-significant risk to patients
The model involved attaching an MR02-100 force sensor to the outside top of the syringe plunger to measure the peak force exerted at the syringe tip To maintain the sterile field the assemblyplunger complex was covered in a small container using Velcro to attach it internally with a thin slit for the cable to exit and connect to the monitor A sterile glove was placed over the container creating a sterile cover over the sensorplunger complex with sterile tape The force sensorplunger complex was connected to a digital force monitor Digital Force Monitor M71 torque indicator for high-speed data capture Multifunctional cables AC1100 connected all necessary ports and a Plug and Test Adapter PTA connected the sensor to the monitor displaying the force MESUR gauge Plus Load for travel analysis software with the monitor was used for peak force analysis
The digital screen allowed recording of the peak force applied on the plunger from which pressure was calculated using the equation Pressure ForceArea Patients were categorized into groups and randomly distributed into four cohort groups A B C D for each syringe size 5ml 10ml 20ml 30ml Peak force data was collected and the corresponding pressure was calculated for each cohort group The sensors or experimental devices used in this study did not come in direct contact with human skin or require sterilization
Patients were followed up one week after the procedure and advised to call the office if there were any adverse reactions The study confidentiality was monitored using HIPAA safety practices Statistical analysis comparing the different syringe pressures using the different syringe sizes was planned to provide recommendations regarding best practices to avoid overuse injuries in healthcare workers
Patients requiring more time to sign the informed consent or needing additional time to read the information or ask questions about the study were offered more time to decide from registration until they reached the preoperative area In the preoperative area research staff asked patients to confirm their decision to participate in the research project and addressed any further questions Patients were given written information in English or Spanish including a short form with an attestation in lay-person terminology regarding the research project and questions clarification Basic information about the data collected and HIPAA privacy was also provided Patients were asked to sign informed consent for enrollment into the study All procedures were performed by one orthopedic spine surgeon Dr Gabriel Garcia-Diaz who conducted all spinal pain injections for pain management procedures at the University Surgery Center Merced CA Data was collected by Ahmadzakaria Arjmand Ahmed Zabiba and Ahmadzaki Arjmand
Patients with cervical thoracic and lumbosacral pain from a single surgical practice OrthoSpine Advance Health Inc were enrolled Procedures were performed at the outpatient University Surgery Outpatient Center Patients were initially assessed by a single orthopedic spine surgeon with more than ten years of experience performing pain management procedures and over 12000 interventional pain injections The patients procedures were ambulatory with patients fasting off blood thinners and under monitored anesthesia care MAC by a licensed anesthesiologist or certified CRNA followed up one week after the procedure
All patients undergoing procedures from October 1 2023 to May 15 2024 were asked about their interest in participating in the research study Interested patients were taken to another conference room by research staff where the study was explained in detail and they were given enough time to consider the alternatives risks and benefits of participation If patients needed more time to read the information or ask more questions they were offered additional time to decide from registration until they reached the preoperative area In the preoperative area patients were asked by research staff to confirm their decision to participate in the research project and address any remaining questions After deciding to participate patients were assigned a User ID which was added to the assigned official injection list from the University Surgery Center for cross-reference This process ensured that only participating patients with User IDs were included in the official procedure list without identifying patient information in the general data collection sheet
After assigning the User ID patients were stratified based on the procedure to be performed Patients were categorized into groups depending on the procedure Category I for sacroiliac joint blocks Category II for transforaminal injection blocks T-thoracic L-lumbar Category III for medial branch blocks C-cervical T-thoracic L-lumbar and Category IV for radiofrequency ablation C-cervical T-thoracic L-lumbar Each category was randomly distributed into four cohort groups A B C D for each syringe size 5ml 10ml 20ml 30ml The syringes and needles used during the procedures were manufactured by BD McKesson or Stryker Table 1
For all patients undergoing injections basic preoperative labs were collected CBC and differential PT PTT INR and urinalysis
The study employed a novel method for measuring the force required to inject medications using different syringe sizes A forcesensor plunger complex was attached to the syringe for real-time force data analysis This device did not come in direct contact with patients and was enclosed in a sterile field minimizing the risk of contamination The forcesensor plunger complex was the safest proposed model designed for humans to be attached to the syringe for real-time force data analysis It did not come in direct contact with the patient and was used at the outside distal end of the syringe plunger enclosed in a sterile field only to collect data for real-time syringe force drug delivery As such it was a Class 1 medical device that did not pose a reasonable risk for illness or injury to the patient The device was only used for clinical design controltrial and not for regularcommon use
There was minimal risk of contamination or any change in the standard of care for the treatment offered besides collecting real-time peak force data analysis The forcesensor plunger complex did not interfere with the handle of the syringe and the monitor was located more than three feet away from the patient The sterile enclosure field was created at the forcesensor plunger complex isolating it from the patient and maintaining the sterile surgical field with non-significant risk of contamination
The forcesensor plunger complex did not perform change or interact with anything except to record the force exerted by the physician It did not interfere with the flow time or location of medicine insertion in the body All parameters were under the control of the physician as usual The equipment was cleaned and sanitized according to approved surgical cleaning and sanitizing agents The entire cart with contents was wiped down and the wheels were sprayed with 70 IPA before entering the operating room Dedicated equipment carts were routinely cleaned and sanitized All equipment used in the forcesensor plunger complex was sanitized using sterile IPA wipes The forcesensor plunger complex model was validated in a cadaver model in 2019 and with a control group at UC Merced in 2023 before requesting permission and approval for data collection There was no change in the procedure or equipment used for the proposed model
Based on the information a request was made for IRB board allowance of the use of the forcesensor plunger professional medical grade equipment to collect the necessary syringe real-time force data analysis required and exempt it from complying with the requirements as Medical Device Class I or for a 510k submission If the forcesensor plunger complex was considered a medical device it should require FDA Medical Class 1 General Controls established in 21CFR part 801 803 and 807 and a 510 K exemption should be requested For data collection there was minimal to zero risk to the patient and minimal risk of contaminating the sterile field The study was performed for the first time in humans after validation in cadavers demonstrating the model provided non-significant risk to patients
The model involved attaching an MR02-100 force sensor to the outside top of the syringe plunger to measure the peak force exerted at the syringe tip To maintain the sterile field the assemblyplunger complex was covered in a small container using Velcro to attach it internally with a thin slit for the cable to exit and connect to the monitor A sterile glove was placed over the container creating a sterile cover over the sensorplunger complex with sterile tape The force sensorplunger complex was connected to a digital force monitor Digital Force Monitor M71 torque indicator for high-speed data capture Multifunctional cables AC1100 connected all necessary ports and a Plug and Test Adapter PTA connected the sensor to the monitor displaying the force MESUR gauge Plus Load for travel analysis software with the monitor was used for peak force analysis
The digital screen allowed recording of the peak force applied on the plunger from which pressure was calculated using the equation Pressure ForceArea Patients were categorized into groups and randomly distributed into four cohort groups A B C D for each syringe size 5ml 10ml 20ml 30ml Peak force data was collected and the corresponding pressure was calculated for each cohort group The sensors or experimental devices used in this study did not come in direct contact with human skin or require sterilization
Patients were followed up one week after the procedure and advised to call the office if there were any adverse reactions The study confidentiality was monitored using HIPAA safety practices Statistical analysis comparing the different syringe pressures using the different syringe sizes was planned to provide recommendations regarding best practices to avoid overuse injuries in healthcare workers
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