Neuraxial Ultrasound Device Study

Labor Pain Clinical Trial

Official title:

Real-time Spine Ultrasound Imaging System: Data Collection Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281249
• Other study ID #: 73172
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method.

Description:

This is a prospective, structured observational study (data collection study) in which Investigators enroll patients who are scheduled for neuraxial anesthesia procedures.

Qualified subjects will be identified and contacted by the anesthesia team prior to their clinical evaluation for labor neuraxial analgesia. Potential patients will be informed of the study, and if study individuals choose to participate and an informed consent form will be signed prior to any study related activities.

When study participants request labor analgesia, investigators will incorporate routine care delivery flow for patients receiving ultrasound guided neuraxial anesthesia.

The clinician will apply ultrasound gel to the Accuro 3S probe (gel inside the probe need not be sterile), and then cover the probe in a sterile probe cover. Sterile ultrasound gel will then be applied to the patient's skin on the back to enable imaging. The Accuro 3S probe will be applied to the patient's spinal region and the clinician will perform scouting scans. Image recordings can be captured by depressing a button located on the probe handle. While performing the scouting scans, the provider will take several image recordings of the spine. The image recordings will include two levels, finding the space, and then at each level plus a spinous process, scanning left and right at each of these points.

The clinician will then administer local anesthetic prior to needle procedures. After needle insertion point and trajectory is established on the ultrasound image, the epidural or spinal needle will then be advanced by the clinician based on their standard technique. While advancing the needle the provider will collect a series of image recordings.

After proper placement of needle/catheter, the Accuro 3S device will then be removed from the patient and they will proceed with standard clinical protocol for post placement care.

Accuro 3S: Primary data collected during this study will be images recordings captured during the scouting and needle placement for the epidural procedure. Images will be acquired directly on the 3S and will not contain patient identifiers.

After collection of data up to 100 patients, Investigators will be moving to clinical analysis.

Rivanna is the sponsor and will be funding this research. The de-identified patient data that Rivanna will receive for analysis include: results of demographic information (e.g. age, height, weight, sex, race, and ethnicity). Obstetric details including gravity, parity, gestational age, labor or cesarean delivery, pain score prior to and after placement. Accuro 3S Images (including scouting images of spine and images of needle placement). Insertion: Number of needle passes and redirects, interspace attempted/inserted; epidural or spinal, and needle gauges used. Number, type, and details of any complication (e.g. wet tap). Failed spinal or epidural including: pain >3/10 after labor epidural, catheter replacement, no or one-sided sensory block, failure to provide cesarean anesthesia, conversion to different type of anesthesia.

Patients will undergo their standard medical and obstetric treatment at the discretion of the obstetrical and anesthesia team. There will be no delay in their treatment due to this study, and the device data will not be available of influence care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged 18 years or older

• The patient is eligible for placement of neuraxial anesthesia, and the patient has agreed to the procedure.

• Patient skin is intact in the area of placement of the epidural or spinal anesthesia.

Exclusion Criteria:

• Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myeloopticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 70,000/µL, or evidence of infection at potential epidural site.

• Presence of orthopedic implants in the spine.

• Skin dyscrasias or allergies to the ultrasound procedure.

• Unable to assume sitting position.

• Body Mass Index (BMI) less than 20 kg/m2.

• Known allergies to ultrasound gel.

• Known history of allergic reactions to adhesives used in standard epidural placement

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• Ultrasound placement device
Device to assist in placement of epidural procedure

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Rivanna Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (8)

Boselli E, Hopkins P, Lamperti M, Estebe JP, Fuzier R, Biasucci DG, Disma N, Pittiruti M, Traskaite V, Macas A, Breschan C, Vailati D, Subert M. European Society of Anaesthesiology and Intensive Care Guidelines on peri-operative use of ultrasound for regional anaesthesia (PERSEUS regional anesthesia): Peripheral nerves blocks and neuraxial anaesthesia. Eur J Anaesthesiol. 2021 Mar 1;38(3):219-250. doi: 10.1097/EJA.0000000000001383. — View Citation

Cittadini G, Martinoli C. [Ultrasound and the bone: a difficult relationship]. Radiol Med. 1995 Jan-Feb;89(1-2):12-7. Italian. — View Citation

Ismail S, Raza A, Munshi K, Tabassum R. Failure rate of labor epidural: An observational study among different levels of trainee anesthesiologists in a university hospital of a developing country. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):210-215. doi: 10.4103/joacp.JOACP_39_19. Epub 2021 Jul 15. — View Citation

Mao Q, He H, Lu Y, Hu Y, Wang Z, Gan M, Yan H, Chen L. Ultrasound probe tilt impedes the needle-beam alignment during the ultrasound-guided procedures. Sci Rep. 2021 Jan 15;11(1):1599. doi: 10.1038/s41598-021-81354-w. — View Citation

Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available. — View Citation

Rajagopalan S, Shah K, Guffey D, Tran C, Suresh M, Wali A. Predictors of difficult epidural placement in pregnant women: A trainees' perspective. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):548-552. doi: 10.4103/joacp.JOACP_340_18. — View Citation

Ring L, Landau R, Delgado C. The Current Role of General Anesthesia for Cesarean Delivery. Curr Anesthesiol Rep. 2021;11(1):18-27. doi: 10.1007/s40140-021-00437-6. Epub 2021 Feb 24. — View Citation

Tiouririne M, Dixon AJ, Mauldin FW Jr, Scalzo D, Krishnaraj A. Imaging Performance of a Handheld Ultrasound System With Real-Time Computer-Aided Detection of Lumbar Spine Anatomy: A Feasibility Study. Invest Radiol. 2017 Aug;52(8):447-455. doi: 10.1097/RLI.0000000000000361. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of difficult block placement	Difficult block placement is defined by need of > 2 needle insertion attempts for succesful neuraxial analgesia/anesthesia	15 minutes
Secondary	Incidence of failed block	Failed labor epidural analgesia and spinal anesthesia will be defined by presence of 1 or more of the following conditions: one-sided or no sensory block, pain >3/10 after epidural placement, epidural replacement, conversion to a different form of anesthesia)	30 minutes
Secondary	Incidence of post-dural puncture headache	Headache developing within 7 days post block placement defined by presence of at least one of the following symptoms: posture dependent headache, symmetric headache posture dependent, neck pain posture dependent	7 days