Yale University
New Haven, Connecticut, 06510, United States
NCT Number: NCT05909085
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Not applicable
New Haven, Connecticut, 06510, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Labor epidural will be performed after marking patient skin using traditional ultrasound guidance
Labor epidural will be performed after marking patient skin using an automated ultrasound device
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.
Time frame: From local anesthetic injection (time 0) till Loss of resistance (in minutes), up to 60 minutes
Number of times the needle is advanced in and out of the skin
Time frame: Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
Time from placing ultrasound on patients back until markings are complete
Time frame: Time at which ultrasound device is placed on patients back (time 0) until image obtained (in minutes), up to 30 minutes
Time from placing ultrasound on patients back until markings are complete
Time frame: Up to 60 minutes
Time will be recorded once local anesthetic is injected and stopped upon obtaining loss of resistance
Time frame: Up to 60 minutes
Accuracy will equal the difference between the estimated depth calculated by the device - actual needle depth as measured from skin to epidural space in centimeters.
Time frame: Up to 60 minutes
Accuracy will equal the difference between the estimated depth calculated by the device - actual needle depth as measured from skin to epidural space in centimeters.
Time frame: 15 - 20 minutes after epidural placement
Assessed after the administration of the loading dose. Patient will be asked to rate their pain on a scale 0-10, 0 = not satisfied, 10 = completely satisfied
Contact information is provided by the study sponsor or research team.
Yale University
Other
A Randomized Double Blinded Controlled Trial to Investigate the Impact of Needle Manipulation and Accuracy of Between Two Commercially Available Ultrasound Devices
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07187427
Behavior, Cardiovascular Diseases
Montreal, Quebec, Canada
View Trial DetailsNCT07007650
Concentration, Labor Analgesia
Chengdu, Sichuan, China
View Trial DetailsNCT06300151
Labor Analgesia
Fuzhou, Fujian, China
View Trial DetailsNCT07292649
Depression, Postpartum, Depressive Disorder
Padova, Veneto, Italy
View Trial Details