A Randomized Double Blinded Controlled Trial to Investigate the Impact of Needle Manipulation and Accuracy of Between Two Commercially Available Ultrasound Devices
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Labor Analgesia
- Sponsor
- Yale University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Number of needle passes
- Status
- Not yet recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
In this double blinded randomized controlled trial, the investigators would like to compare the effects on needle manipulation when relatively inexperienced sonographist (< 1 year of ultrasound experience) perform ultrasound guided labor epidurals utilizing a traditional handheld ultrasound versus a handheld device that was engineered to provide automated guidance. The primary outcome of this study would be number of needle passes.
Detailed Description
Patient will be approached upon admission to labor and delivery floor (Standard of care). The study will be presented to the patient and if they agree, they will be consented. (Study). Upon epidural patient request patient will be randomized to A-US vs B-US based on the randomization table. Ten envelopes will be available with the randomization choice. (Study). The resident will walk in with both US devices into the room (for patient blinding) and perform scan with the device the randomization table called for. (Study). After performing scan and markings of the patients back, the research fellow or clinical fellow will be called into the room to evaluate the number of needle manipulation and provide surveys related to patient and labor analgesia satisfaction. (Study). Number of needle insertion attempts: defined as advancement of the needle through the skin in an effort to enter the epidural space; a needle requiring withdrawal from the skin for reinsertion is to be counted as an additional insertion attempt. Time to landmark identification: defined as the time interval between the start of needle puncture site identification and the time to first needle puncture attempt. The start time of needle puncture site identification in both the LT and UST corresponds to when the resident physician first places his/her hand on the patient to palpate the back. In both groups, all materials, supplies, and equipment will be prepared and readily available prior to the start of the procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ASA-1, ASA-2, and ASA-3
- •Patients with no known back deformities
- •Ability to sit upright for epidural placement
- •No prior lumbar surgery
- •No allergies to ultrasound gel
Exclusion Criteria
- •Coagulopathy
- •Low platelet count
- •Allergies to local anesthetics
Outcomes
Primary Outcomes
Number of needle passes
Time Frame: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
Number of ventral needle movements without removing needle from skin. A needle pass is defined as any forward advancement or withdraw and forward redirection of the needle without withdraw from the skin.
Secondary Outcomes
- Number of Needle attempts(From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes)
- Time from local anesthetic injection till time of epidural space identification(Up to 60 minutes)
- Time to obtain ultrasound images with traditional ultrasound device(Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes)
- Accuracy of handheld ultrasound - difference between predicted epidural space distance minus actual needle distance(Up to 60 minutes)
- Accuracy of automated ultrasound device - difference between predicted epidural space distance minus actual needle distance(Up to 60 minutes)
- Time to obtain images with automated ultrasound device(Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes)
- Patient satisfaction(15 - 20 minutes after epidural placement)