Ultrasonographic and Comfort Comparison of Sitting Fetal Cross-legged Position With Lateral Decubitus Fetal Position

NCT03889223 | Completed

• 1 other identifier: KAEK- tez
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A prosperous neuraxial anesthesia positioning ensures a raised chance of successful needle placement. The primary aim is to compare "Sitting Cross-legged Fetal Position -SCF" with "Lateral Decubitus Fetal Position-LDF" anatomically via sonography. Secondary aim is to compare their comfort.

Conditions

Anesthesia, Conduction

Keywords

neuraxial anesthesia positioning technique; sitting cross-legged fetal position; lateral decubitus fetal position; ultrasonography

Outcome Measures

Primary Outcomes (18)

• Interspinous gap opening (ISGO) measurement in the SCF

  the wideness measurement of the ISGO in millimeters via ultrasonography (USG) in the SCF

  For the SCF technique, ISGO is measured in the first 10 minutes(mins.) time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• Left paraspinal muscle (LPM) measurements in the SCF

  the diameter measurement of the LPM in millimeters via ultrasonography in the SCF

  For the SCF technique, LPM is measured between the 10th and 20th mins. of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• Right paraspinal muscle (RPM) measurements in the SCF

  the diameter measurement of the RPM in millimeters via ultrasonography in the SCF

  For the SCF technique, RPM is measured in between the 20th and 30th mins. of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• The mean of bilateral paraspinal muscles (MPM) in the SCF

  Measured by ( \[LPM+RPM\]/2) in millimeters in the SCF

  For the SCF technique, MPM measurement is planned to be done in between the 30th and 40th mins. of the study,in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• Subcutaneous tissue (ST) measurements in the SCF

  the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the SCF

  For the SCF technique, ST measurement is planned to be done in between the 40th and 50th mins. of the study,in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• The skin to spinous process (S-SP) measurements in the SCF

  the depth measurement of the skin to spinous process in millimeters via ultrasonography in the SCF

  : For the SCF technique, S-SP measurement is planned to be done in between the 50th and 60th mins. of the study,in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• Interspinous gap opening (ISGO) measurement in the LDF

  the wideness measurement of the ISGO in millimeters via ultrasonography in the LDF

  ISGO measurement in the LDF will be done right after NRS evaluation of the SCF, in between the 70th and 80th mins. of the study,in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• Left paraspinal muscle (LPM) measurements in the LDF

  the diameter measurement of the LPM in millimeters via ultrasonography in the LDF

  LPM measurement in the LDF will be done in between the 80th and 90th mins. of the study,in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• Right paraspinal muscle (RPM) measurements in the LDF

  the diameter measurement of the RPM in millimeters via ultrasonography in the LDF

  RPM measurement in the LDF will done in between the 90th and 100th mins. of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant through study completion up to 20 weeks.

• The mean of bilateral paraspinal muscles (MPM) in the LDF

  Measured by ( \[LPM+RPM\]/2) in millimeters in the LDF

  MPM measurement in the LDF will be done in between the 100th and 110th mins. time of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• Subcutaneous tissue (ST) measurements in the LDF

  the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the LDF

  ST measurement in the LDF will be done in between the 110th and 120th mins. time, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• The skin to spinous process (S-SP) measurements in the LDF

  the depth measurement of the skin to spinous process in millimeters via ultrasonography in the LDF

  S-SP measurement in the LDF will be done in between the 120th and 130th mins. of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• the change of ISGO (ISGO SCF-LDF)

  Measured by calculation; (\[ISGO in the SCF in millimeters\]-\[ISGO in the LDF in millimeters\])

  ISGO in the SCF measured in the first 10mins., and ISGO in the LDF measured in between the 70th and 80th mins. of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• the change of LPM (LPM SCF-LDF )

  Measured by calculation; (\[LPM in SCF in millimeters\]-\[LPM in LDF in millimeters\])

  LPM in the SCF measured in between the 10th and 20th mins., and LPM in the LDF measured in between the 80th and 90th mins., in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• the change of RPM (RPM SCF-LDF)

  Measured by calculation (\[RPM in SCF in millimeters\]-\[RPM in LDF in millimeters\])

  RPM in the SCF measured in between the 20th and 30th mins., and RPM in the LDF measured in between 90th and 100th mins., in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• the change of MPM (MPM SCF-LDF)

  Measured by calculation (\[MPM in SCFin millimeters\]-\[MPM in LDF in millimeters\])

  MPM in the SCF measured in between the 30th and 40th mins., and MPM in the LDF measured in between 100th and 110th mins., in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• the change of ST (ST SCF-LDF)

  Measured by calculation (\[ST in SCF in millimeters\]-\[ST in LDF in millimeters\])

  ST in the SCF measured in between the 40th and 50th mins., and ST in the LDF measured in between the 110th and 120th, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

• the change of S-SP (S-SP SCF-LDF)

  Measured by calculation (\[S-SP in SCF in millimeters\]-\[S-SP in LDF in millimeters\])

  S-SP in the SCF measured in between the 50th and 60th mins., and S-SP in the LDF measured in between the 120th and 130th mins., in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

Secondary Outcomes (2)

• Comfort evaluation in the SCF via 7-point numerical rating scale (NRS)

  NRS measurement is planned to be done right after the SCF position in between the 60th and 70th mins. time,in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks..

• Comfort evaluation in the LDF via 7-point numerical rating scale (NRS)

  NRS measurement is planned to be done right after the LDF position in between the 130th and 140th mins. time of the study, in 10 mins. time of the total 3hr and 30 mins. study, for each participant, through study completion up to 20 weeks.

Study Arms (2)

The LDF neuraxial positioning technique

ACTIVE COMPARATOR

In the LDF neuraxial positioning technique, fifty participants were planned to lay down the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist. Volunteers jaw touch to chest and legs in abdominal flexion with hands are on the knees. The position is completed with the back curved in the fetal position. Then the USG is performed by the consultant Radiology M.D. in maximum 2 hours time to each participant, and the 7-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 15 weeks.

Procedure: Anatomical intervention with USG and comfort evaluation with NRS

The SCF neuraxial positioning technique

EXPERIMENTAL

In the SCF neuraxial positioning technique, the same fifty participants were planned to sit on the same part of the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist with legs crossed, forearms of the participants are on the lap and hands are on the knees, and the position is completed with the back curved in the fetal position.Then the USG is performed by the consultant Radiology M.D. in maximum 2 hours time to each participant, and the 7-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 15 weeks.

Procedure: Anatomical intervention with USG and comfort evaluation with NRS

Interventions

Anatomical intervention with USG and comfort evaluation with NRS PROCEDURE

The anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS

The LDF neuraxial positioning technique; The SCF neuraxial positioning technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy and adult volunteers,
• must be able to do the sitting cross-legged fetal position ( SCF ),
• must be able to do the Lateral decubitus fetal position (LDF).

You may not qualify if:

• Lumbar hernia,
• Scoliosis,
• History of spine surgery,
• History of trauma,
• History of lower back pain,
• Arthropathy {especially pelvic or knee problems},
• Could not be able to do one or both of the two neuraxial position techniques.

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Yeditepe University Hospital

Istanbul, İçerenköy, Turkey (Türkiye)

Location

Related Publications (1)

• Dimaculangan DP, Mazer JA, Maracaja-Neto LF. Sonographic evaluation of lumbar interlaminar space opening in a variety of patient body positions for optimal neuraxial anesthesia delivery. J Clin Anesth. 2016 Nov;34:159-65. doi: 10.1016/j.jclinane.2016.03.045. Epub 2016 May 6.

  PMID: 27687365 RESULT

Study Officials

• Ferda Kartufan, Assist.Prof.

  Anesthesiology and Reanimation Department

  PRINCIPAL INVESTIGATOR

• Feyza Aksu, MD

  Anesthesiology and Reanimation Department

  STUDY CHAIR

• Özge Köner, Prof.

  Anesthesiology and Reanimation Department

  STUDY DIRECTOR

• Ayşegül Görmez, Consult.MD

  Radiology Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The ultrasonography was made by a consultant radiologist (M.D.) The consultant didn't know which position was for control and which was the one the study evaluates. Although investigators were trying to mask the outcomes assessor; the consultant saw the positions because there is no way to hide the sitting positions of the participants.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Systematic randomization was made from 150 volunteers, and 50 participants were chosen. All 50 participants were planned to sit on the stretcher in both of the two positioning techniques sequentially (one after another). The two positioning techniques are SCF and LDF. The investigator was planned to record all of the participants' anatomical measurements in both of those positioning techniques evaluated via ultrasonography. After each position participants were planned to evaluate each positioning technique's comfort by 7-point numerical rating scale from minimum 1 meaning "very bad" to maximum 7 meaning "excellent."

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 26, 2019
• Study Start: March 20, 2019
• Primary Completion: June 15, 2019
• Study Completion: June 25, 2019
• Last Updated: July 1, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)