Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178750
Status:
WITHDRAWN
Last Update Posted:
2020-11-05
First Post:
2005-09-13
Brief Title:
Loss of Resistance Versus CompuFlo for Epidural Placement
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
A Randomized Clinical Comparison of the Loss of Resistance Technique Versus the CompuFlo Computerized Syringe Pump for Proper Epidural Placement
Status:
WITHDRAWN
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study did not start due to investigator time constraints
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare how well the CompuFlo computerized syringe pump works as compared to the traditional method of inserting an epidural a needle placed in ones back to give pain medicine
Detailed Description:
It is possible to utilize epidural anesthesia as the sole anesthetic technique for thoracic abdominal and lower extremity surgeries as a method of postoperative pain management after surgery and for pain relief during labor and delivery However despite the various benefits of epidural anesthesia this procedure is not utilized to its maximum potential in the operating room One reason for inadequate utilization of this procedure is the difficulty in properly identifying the epidural space Current techniques for identifying the epidural space rely on the subjective perception of the operator on loss of resistance to air or saline as the needle passes from the ligamentum flavum into the epidural space CompuFlos pressure-sensing technology provides an objective measurement for proper placement of the epidural
Very little advancement has been made in improving training to identify the correct location of the epidural space Epidural anesthesia has a relatively higher failure rate when performed by residents in training The skills of trainees differ greatly and there are no standard teaching methods to teach epidural anesthesia Statistical analysis conducted by Naik et al concluded that some residents may need as many as 75 attempts at epidural anesthesia to ensure proficiency
The CompuFlo is a computerized syringe pump capable of volume and pressure-controlled infusion It has a pressure sensor and a mathematical algorithm capable of determining the pressure at the needle tip Pressures are continuously monitored and displayed which are reflected by acoustic changes in tone A dramatic pressure decrease and a high tissue compliance pressure does not increase despite continuous infusion signifies entrance into the epidural space Combining a program with a low upper pressure limit and a high infusion rate mimics the technique used by the loss of resistance with saline proponents constant pressure on the plunger It combines the feel of inserting an epidural needle with the visualization of the pressure level as well as a sound indicator to indicate proper placement
Very little advancement has been made in improving training to identify the correct location of the epidural space Epidural anesthesia has a relatively higher failure rate when performed by residents in training The skills of trainees differ greatly and there are no standard teaching methods to teach epidural anesthesia Statistical analysis conducted by Naik et al concluded that some residents may need as many as 75 attempts at epidural anesthesia to ensure proficiency
The CompuFlo is a computerized syringe pump capable of volume and pressure-controlled infusion It has a pressure sensor and a mathematical algorithm capable of determining the pressure at the needle tip Pressures are continuously monitored and displayed which are reflected by acoustic changes in tone A dramatic pressure decrease and a high tissue compliance pressure does not increase despite continuous infusion signifies entrance into the epidural space Combining a program with a low upper pressure limit and a high infusion rate mimics the technique used by the loss of resistance with saline proponents constant pressure on the plunger It combines the feel of inserting an epidural needle with the visualization of the pressure level as well as a sound indicator to indicate proper placement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None