Palpation and ACCURO for Placing Spinal in C-section

Does the Use of Both Palpation and Accuro as Compared to Palpation Alone or Use of Accuro Alone in a Single Patient Increase the First Pass Success Rate in Placing Spinals or Combined Spinal Epidurals for Cesarean Sections.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03090295

Enrollment

Registered

2017-03-24

Start date

2017-03-13

Completion date

2018-03-30

Last updated

2022-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia,Obstetrical

Brief summary

The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to create pictures of the spine in three dimensions. This may allow the physician to view the spine in more detail for procedures such as spinal anesthesia and other diagnostic procedures. We aim to assess the benefit of using both the Accuro and traditional landmark palpation technique to determine accurate spinal level in women who undergo cesarean section. This study will also assess provider preference for use of both Accuro and palpation compared with palpation alone or use of Accuro alone. Anesthesia Providers will first identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level, which will be marked with a single dot from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5 interspace. Results will be compared to results obtained in IRB 18070 Handheld 3D lumbar spine navigation: A clinical validation study RM002 where subjects who were undergoing a C-section were randomized to either palpation or Accuro alone.

Interventions

DEVICEPalpation and Accuro

Identify placement for spinal

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

* • Patients between the ages of 18 and 45 presenting for a C-section delivery or scheduled for elective Cesarean section * ASA-1, ASA-2, and ASA-3 * Patients with no known back deformities * Ability to sit upright for spinal placement * No prior lumbar surgery * No allergies to ultrasound gel

Exclusion criteria

* • Unable or unwilling to give informed consent

Design outcomes

Primary

Measure	Time frame	Description
success rates	Day 1	Success rates: defined as successful spinal administration on the first needle insertion attempt.

Secondary

Measure	Time frame	Description
Level of spinal placement: a record of the vertebral level where the spinal is administered.	Day 1	Level of spinal placement: a record of the vertebral level where the spinal is administered.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026