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

Primary Purpose

Anesthesia, Conduction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Anatomical intervention with USG and comfort evaluation with NRS
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anesthesia, Conduction focused on measuring neuraxial anesthesia positioning technique, sitting cross-legged fetal position, lateral decubitus fetal position, ultrasonography

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yeditepe University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

The LDF neuraxial positioning technique

The SCF neuraxial positioning technique

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Interspinous gap opening (ISGO) measurement in the SCF
the wideness measurement of the ISGO in millimeters via ultrasonography (USG) in the SCF
Left paraspinal muscle (LPM) measurements in the SCF
the diameter measurement of the LPM in millimeters via ultrasonography in the SCF
Right paraspinal muscle (RPM) measurements in the SCF
the diameter measurement of the RPM in millimeters via ultrasonography in the SCF
The mean of bilateral paraspinal muscles (MPM) in the SCF
Measured by ( [LPM+RPM]/2) in millimeters in the SCF
Subcutaneous tissue (ST) measurements in the SCF
the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the SCF
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
Interspinous gap opening (ISGO) measurement in the LDF
the wideness measurement of the ISGO in millimeters via ultrasonography in the LDF
Left paraspinal muscle (LPM) measurements in the LDF
the diameter measurement of the LPM in millimeters via ultrasonography in the LDF
Right paraspinal muscle (RPM) measurements in the LDF
the diameter measurement of the RPM in millimeters via ultrasonography in the LDF
The mean of bilateral paraspinal muscles (MPM) in the LDF
Measured by ( [LPM+RPM]/2) in millimeters in the LDF
Subcutaneous tissue (ST) measurements in the LDF
the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the LDF
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
the change of ISGO (ISGO SCF-LDF)
Measured by calculation; ([ISGO in the SCF in millimeters]-[ISGO in the LDF in millimeters])
the change of LPM (LPM SCF-LDF )
Measured by calculation; ([LPM in SCF in millimeters]-[LPM in LDF in millimeters])
the change of RPM (RPM SCF-LDF)
Measured by calculation ([RPM in SCF in millimeters]-[RPM in LDF in millimeters])
the change of MPM (MPM SCF-LDF)
Measured by calculation ([MPM in SCFin millimeters]-[MPM in LDF in millimeters])
the change of ST (ST SCF-LDF)
Measured by calculation ([ST in SCF in millimeters]-[ST in LDF in millimeters])
the change of S-SP (S-SP SCF-LDF)
Measured by calculation ([S-SP in SCF in millimeters]-[S-SP in LDF in millimeters])

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 12, 2019
Last Updated
June 27, 2019
Sponsor
Yeditepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03889223
Brief Title
Ultrasonographic and Comfort Comparison of Sitting Fetal Cross-legged Position With Lateral Decubitus Fetal Position
Official Title
Ultrasonographic and Comfort Comparison of Sitting Fetal Cross-legged Position With Lateral Decubitus Fetal Position on Healthy Volunteers; a Randomized, Consecutive-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeditepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Conduction
Keywords
neuraxial anesthesia positioning technique, sitting cross-legged fetal position, lateral decubitus fetal position, ultrasonography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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."
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The LDF neuraxial positioning technique
Arm Type
Active Comparator
Arm Description
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.
Arm Title
The SCF neuraxial positioning technique
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Anatomical intervention with USG and comfort evaluation with NRS
Intervention Description
The anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS
Primary Outcome Measure Information:
Title
Interspinous gap opening (ISGO) measurement in the SCF
Description
the wideness measurement of the ISGO in millimeters via ultrasonography (USG) in the SCF
Time Frame
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.
Title
Left paraspinal muscle (LPM) measurements in the SCF
Description
the diameter measurement of the LPM in millimeters via ultrasonography in the SCF
Time Frame
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.
Title
Right paraspinal muscle (RPM) measurements in the SCF
Description
the diameter measurement of the RPM in millimeters via ultrasonography in the SCF
Time Frame
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.
Title
The mean of bilateral paraspinal muscles (MPM) in the SCF
Description
Measured by ( [LPM+RPM]/2) in millimeters in the SCF
Time Frame
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.
Title
Subcutaneous tissue (ST) measurements in the SCF
Description
the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the SCF
Time Frame
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.
Title
The skin to spinous process (S-SP) measurements in the SCF
Description
the depth measurement of the skin to spinous process in millimeters via ultrasonography in the SCF
Time Frame
: 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.
Title
Interspinous gap opening (ISGO) measurement in the LDF
Description
the wideness measurement of the ISGO in millimeters via ultrasonography in the LDF
Time Frame
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.
Title
Left paraspinal muscle (LPM) measurements in the LDF
Description
the diameter measurement of the LPM in millimeters via ultrasonography in the LDF
Time Frame
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.
Title
Right paraspinal muscle (RPM) measurements in the LDF
Description
the diameter measurement of the RPM in millimeters via ultrasonography in the LDF
Time Frame
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.
Title
The mean of bilateral paraspinal muscles (MPM) in the LDF
Description
Measured by ( [LPM+RPM]/2) in millimeters in the LDF
Time Frame
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.
Title
Subcutaneous tissue (ST) measurements in the LDF
Description
the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the LDF
Time Frame
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.
Title
The skin to spinous process (S-SP) measurements in the LDF
Description
the depth measurement of the skin to spinous process in millimeters via ultrasonography in the LDF
Time Frame
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.
Title
the change of ISGO (ISGO SCF-LDF)
Description
Measured by calculation; ([ISGO in the SCF in millimeters]-[ISGO in the LDF in millimeters])
Time Frame
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.
Title
the change of LPM (LPM SCF-LDF )
Description
Measured by calculation; ([LPM in SCF in millimeters]-[LPM in LDF in millimeters])
Time Frame
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.
Title
the change of RPM (RPM SCF-LDF)
Description
Measured by calculation ([RPM in SCF in millimeters]-[RPM in LDF in millimeters])
Time Frame
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.
Title
the change of MPM (MPM SCF-LDF)
Description
Measured by calculation ([MPM in SCFin millimeters]-[MPM in LDF in millimeters])
Time Frame
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.
Title
the change of ST (ST SCF-LDF)
Description
Measured by calculation ([ST in SCF in millimeters]-[ST in LDF in millimeters])
Time Frame
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.
Title
the change of S-SP (S-SP SCF-LDF)
Description
Measured by calculation ([S-SP in SCF in millimeters]-[S-SP in LDF in millimeters])
Time Frame
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 Measure Information:
Title
Comfort evaluation in the SCF via 7-point numerical rating scale (NRS)
Description
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.
Time Frame
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..
Title
Comfort evaluation in the LDF via 7-point numerical rating scale (NRS)
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferda Kartufan, Assist.Prof.
Organizational Affiliation
Anesthesiology and Reanimation Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Feyza Aksu, MD
Organizational Affiliation
Anesthesiology and Reanimation Department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Özge Köner, Prof.
Organizational Affiliation
Anesthesiology and Reanimation Department
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ayşegül Görmez, Consult.MD
Organizational Affiliation
Radiology Department
Official's Role
Study Chair
Facility Information:
Facility Name
Yeditepe University Hospital
City
Istanbul
State/Province
İçerenköy
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27687365
Citation
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.
Results Reference
result

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

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