Influence of Body Positioning on the Identification of Tuffier's Line Using the Palpation Method: An Ultrasound Study

NCT03128541 | Unknown

• 1 other identifier: 218764
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to ascertain whether being placed in a sitting or lateral decubitus position, influences identification of the midpoint of the L4/L5 intervertebral space, using manual demarcation of Tuffier's line. Participants will be randomly assigned to a sitting or lateral decubitus position. The mid-point of the L4/L5 intervertebral space will be identified using anatomical palpation and compared to the "true" mid-point measured by ultrasound. The procedure will be repeated in both positions on the same participant.The study will be a prospective, randomized, double blinded, crossover trial

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (1)

• Discrepancy in distance between palpation vs. ultrasound midpoint of L4/5. interspace.

  Distance (mm) between the mid-point of the L4/L5 intervertebral space in sitting and lateral decubitus positions, identified through manual palpation compared to the "true" mid-point measured by ultrasound.

  15-30 minutes

Secondary Outcomes (1)

• Discrepancy in distance between ultrasound midpoint of L4/5 in sitting vs. lateral position

  15-30 minutes

Study Arms (2)

Ultrasound Spine in sitting position

Participants will be assigned to a sitting decubitus position to identify the Tuffier's Line

Diagnostic Test: Ultrasound spine

Ultrasound Spine in lateral position

Participants will be assigned to a lateral decubitus position to identify the Tuffier's Line

Diagnostic Test: Ultrasound spine

Interventions

Ultrasound spine DIAGNOSTIC_TEST

A ultrasound of the lumbar spine of each patient will be performed in both positions to identify vertebral levels

Ultrasound Spine in lateral position; Ultrasound Spine in sitting position

Eligibility Criteria

• Age: 16 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant parturients in the third trimester.

You may qualify if:

• \>37 weeks gestation
• BMI\<40
• Singleton pregnancy
• Aged 16 to 65 years old.
• Latent phase of labour (\<4cm cervix dilatation).

You may not qualify if:

• Previous spinal surgery
• Scoliosis
• Age\<16
• Patient unable to tolerate positions
• Degenerative disease of the spine
• Patient refusal or inability to provide informed consent
• Patient in established labour (i.e. \>4cm cervical dilatation)

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

RECRUITING

Study Officials

• Nhathien Nguyen-Lu, FRCA

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nhathien Nguyen-Lu, FRCA

CONTACT

0207 188 7188; nat.nguyen-lu@gstt.nhs.uk

Andrew Hartopp, FRCA

CONTACT

0207 199 7188; andrewhartopp@doctors.org.uk

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: April 14, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)