Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia

NCT04757805 | Completed Results FDA Device

• 1 other identifier: STUDY00000558
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Although the current standard for lumbar puncture and spinal anesthesia is the use of manual palpation of surface landmarks to identify the correct interspace, performance of the procedure at too high of a level may increase the incidence of adverse effects. The current study will evaluate the efficacy of ultrasound in identifying the correct intervertebral space for lumbar puncture thereby improving the safety of the procedure.

Conditions

Anesthesia, Local; Infant Conditions

Outcome Measures

Primary Outcomes (2)

• Intended Interspace

  The vertebral interspace that the anesthesia provider believes that they had marked \& identified by manual palpation

  Immediately prior to spinal anesthesia

• Actual Interspace of Provider's Mark

  The actual vertebral interspace that the anesthesia provider marked \& identified, as verified by ultrasound.

  Immediately prior to spinal anesthesia

Secondary Outcomes (3)

• Level of Conus Medullaris - Sitting

  Immediately prior to spinal anesthesia

• Time to Mark

  Immediately prior to spinal anesthesia

• Time to Conduct Ultrasound

  Immediately prior to spinal anesthesia

Study Arms (1)

Spinal anesthesia

EXPERIMENTAL

Infants receiving spinal anesthesia for standard of care procedure

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.

Spinal anesthesia

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients less than 1 year of age scheduled for spinal anesthesia for elective lower abdominal, urologic, or lower extremity surgery at Nationwide Children's Hospital

You may not qualify if:

• Parents unwilling for their children to undergo spinal anesthesia for surgery.
• Children with known spinal anomalies including sacral dimple.
• Children with coagulation abnormalities or receiving anticoagulation which precludes the use of spinal anesthesia.
• Children with superficial or deep infections over the spine which precludes the use of spinal anesthesia.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Giorgio Veneziano, MD
• Organization: Nationwide Children's Hospital

Giorgio.Veneziano@nationwidechildrens.org

614-722-4200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: May 6, 2021
• Primary Completion: March 21, 2022
• Study Completion: March 21, 2022
• Last Updated: January 26, 2023
• Results First Posted: September 15, 2022

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)