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

Ultrasonographic and Comfort Comparison of Sitting Fetal Cross-legged Position With Lateral Decubitus Fetal Position on Healthy Volunteers; a Randomized, Consecutive-controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Conduction
• Intervention / Treatment: Procedure: Anatomical intervention with USG and comfort evaluation with NRS

Detailed Description

Fifty participants were included to this prospective, randomized, consecutive controlled clinical study. Six parameters were evaluated in each position; subcutaneous tissue (ST), skin to spinous process (S-SP), transverse diameters of bilateral paraspinal muscles (left paraspinal muscle [LPM] and right paraspinal muscle [RPM]), interspinous gap opening (ISGO), mean of bilateral paraspinal muscles (MPM). The change of every measurement recorded via ultrasonography (USG) according to the positioning techniques were also calculated. The calculations are explained briefly in primary outcomes (including the change of SCF-LDF in ST, S-SP, LPM, RPM, MPM, ISGO). Stretcher comfort (SC), position comfort (PC), lumbar comfort (LC), and abdominal comfort (AC) were evaluated by the participants with the 7-point Numerical Rating Scale (NRS).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İçerenköy
    • Istanbul, İçerenköy, Turkey
      • Yeditepe University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: The LDF neuraxial positioning technique; 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 anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS
EXPERIMENTAL: The SCF neuraxial positioning technique; 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; The anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort evaluation in the SCF via 7-point numerical rating scale (NRS)	Comfort evaluation of the SCF technique is planned to be done by the participant right after USG. The 7-point NRS includes 7 scale. The minimum scale is"1" means very bad, "2" means bad, "3" means fair, "4" means normal, "5" means good, "6" means very good, and the maximum scale is "7" means excellent.	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)	Comfort evaluation of the LDF technique is planned to be done by the participant right after USG. The 7-point NRS includes 7 scale. The minimum scale is"1" means very bad, "2" means bad, "3" means fair, "4" means normal, "5" means good, "6" means very good, and the maximum scale is "7" means excellent.	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.

Collaborators and Investigators

• Sponsor: Yeditepe University
• Investigators: Principal Investigator: Ferda Kartufan, Assist.Prof., Anesthesiology and Reanimation Department; Study Chair: Feyza Aksu, MD, Anesthesiology and Reanimation Department; Study Director: Özge Köner, Prof., Anesthesiology and Reanimation Department; Study Chair: Ayşegül Görmez, Consult.MD, Radiology Department

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2019
• Primary Completion (ACTUAL): June 15, 2019
• Study Completion (ACTUAL): June 25, 2019

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (ACTUAL): March 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: ultrasonography; neuraxial anesthesia positioning technique; sitting cross-legged fetal position; lateral decubitus fetal position
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: KAEK- tez

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No