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

• ClinicalTrials.gov Identifier: NCT03889223
• Recruitment Status: Completed
• First Posted: March 26, 2019
• Last Update Posted: July 1, 2019
• Sponsor: Yeditepe University
• Information provided by (Responsible Party): Fatma Ferda Kartufan, Yeditepe University

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia, Conduction	Procedure: Anatomical intervention with USG and comfort evaluation with NRS	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment

Intervention 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: Single (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.
• Primary Purpose: Other
• 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
• Actual Study Start Date: March 20, 2019
• Actual Primary Completion Date: June 15, 2019
• Actual Study Completion Date: June 25, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Interspinous gap opening (ISGO) measurement 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. ]
   the wideness measurement of the ISGO in millimeters via ultrasonography (USG) in the SCF
2. Left paraspinal muscle (LPM) measurements 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. ]
   the diameter measurement of the LPM in millimeters via ultrasonography in the SCF
3. Right paraspinal muscle (RPM) measurements 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. ]
   the diameter measurement of the RPM in millimeters via ultrasonography in the SCF
4. The mean of bilateral paraspinal muscles (MPM) 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. ]
   Measured by ( [LPM+RPM]/2) in millimeters in the SCF
5. Subcutaneous tissue (ST) measurements 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. ]
   the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the SCF
6. The skin to spinous process (S-SP) measurements 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. ]
   the depth measurement of the skin to spinous process in millimeters via ultrasonography in the SCF
7. Interspinous gap opening (ISGO) measurement 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. ]
   the wideness measurement of the ISGO in millimeters via ultrasonography in the LDF
8. Left paraspinal muscle (LPM) measurements 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. ]
   the diameter measurement of the LPM in millimeters via ultrasonography in the LDF
9. Right paraspinal muscle (RPM) measurements 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. ]
   the diameter measurement of the RPM in millimeters via ultrasonography in the LDF
10. The mean of bilateral paraspinal muscles (MPM) 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. ]
    Measured by ( [LPM+RPM]/2) in millimeters in the LDF
11. Subcutaneous tissue (ST) measurements 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. ]
    the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the LDF
12. The skin to spinous process (S-SP) measurements 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. ]
    the depth measurement of the skin to spinous process in millimeters via ultrasonography in the LDF
13. the change of ISGO (ISGO SCF-LDF) [ 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. ]
    Measured by calculation; ([ISGO in the SCF in millimeters]-[ISGO in the LDF in millimeters])
14. the change of LPM (LPM SCF-LDF ) [ 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. ]
    Measured by calculation; ([LPM in SCF in millimeters]-[LPM in LDF in millimeters])
15. the change of RPM (RPM SCF-LDF) [ 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. ]
    Measured by calculation ([RPM in SCF in millimeters]-[RPM in LDF in millimeters])
16. the change of MPM (MPM SCF-LDF) [ 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. ]
    Measured by calculation ([MPM in SCFin millimeters]-[MPM in LDF in millimeters])
17. the change of ST (ST SCF-LDF) [ 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. ]
    Measured by calculation ([ST in SCF in millimeters]-[ST in LDF in millimeters])
18. the change of S-SP (S-SP SCF-LDF) [ 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. ]
    Measured by calculation ([S-SP in SCF in millimeters]-[S-SP in LDF in millimeters])

Secondary Outcome Measures :

1. Comfort evaluation in the SCF via 7-point numerical rating scale (NRS) [ 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.. ]
   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.
2. Comfort evaluation in the LDF via 7-point numerical rating scale (NRS) [ 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. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Turkey

Yeditepe University Hospital

Istanbul, İçerenköy, Turkey

Sponsors and Collaborators

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

More Information

Publications of Results:

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.

• Responsible Party: Fatma Ferda Kartufan, Assistant Professor, Yeditepe University
• ClinicalTrials.gov Identifier: NCT03889223
• Other Study ID Numbers: KAEK- tez
• First Posted: March 26, 2019
• Last Update Posted: July 1, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fatma Ferda Kartufan, Yeditepe University:

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

Additional relevant MeSH terms:

Pressure Ulcer; Skin Ulcer; Skin Diseases