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A New Neuraxial Position Technique " The Anatolian Sitting Position- Sitting Fetal Cross-legged"

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ClinicalTrials.gov Identifier: NCT03741465
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Fatma Ferda Kartufan, Yeditepe University

Brief Summary:
A prosperous neuraxial anesthesia positioning ensures a raised chance of successful needle placement. The primary aim is to compare "The Anatolian sitting position-ASP" with "The Sitting Fetal Position-SFP" sonographically. Secondary aim is to compare their comfort.

Condition or disease Intervention/treatment Phase
Anesthesia, Conduction Procedure: The SFP technique Procedure: The ASP technique 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 (the Anatolian Sitting Position [ASP] could also be named as "sitting fetal cross-legged position" and the Sitting Fetal Position [SFP] which is a traditional sitting position) were also calculated. The calculations are explained briefly in primary outcomes (including the change of ASP-SFP 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 5-point Numerical Rating Scale (NRS).

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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 1) sitting fetal position-" the SFP" ( a traditional position ) and 2) sitting fetal cross-legged-" the ASP" ( a new position, named as " Anatolian sitting position"). 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 5-point numerical rating scale from minimum 1 meaning "poor" to maximum 5 meaning "excellent."

Masking: Single (Outcomes Assessor)
Masking Description: The ultrasonography was made by a consultant radiologist (M.D.) Although 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. So there is a paradox if the consultant is masked or not.
Primary Purpose: Other
Official Title: "The Anatolian Sitting Neuraxial Position Technique"; is it Beneficial? A Prospective Clinical Comparison Trial Via Ultrasonography
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : September 20, 2018
Actual Study Completion Date : September 20, 2018

Arm Intervention/treatment
Active Comparator: The SFP technique
In the SFP neuraxial positioning technique, fifty participants were planned to sit on the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist with legs hanging freely, forearms on the lap and hand 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 5-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 24 weeks.
Procedure: The SFP technique
The USG, and the 5-point NRS evaluation in the SFP

Experimental: The ASP technique
In the ASP 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 5-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 24 weeks.
Procedure: The ASP technique
The USG, and the 5-point NRS evaluation in the ASP




Primary Outcome Measures :
  1. Interspinous gap opening (ISGO) measurement in the ASP [ Time Frame: For the ASP technique, ISGO is measured in the first 10 minutes(mins.) time, for each participant, through study completion. ]
    the wideness measurement of the ISGO in millimeters via ultrasonography (USG) in the ASP

  2. Left paraspinal muscle (LPM) measurements in the ASP [ Time Frame: For the ASP technique, LPM is measured in between 10mins. and 20mins. time, for each participant, through study completion. ]
    the diameter measurement of the LPM in millimeters via ultrasonography in the ASP

  3. Right paraspinal muscle (RPM) measurements in the ASP [ Time Frame: For the ASP technique, RPM is measured in between 20mins. and 30mins. time, for each participant, through study completion. ]
    the diameter measurement of the RPM in millimeters via ultrasonography in the ASP

  4. The mean of bilateral paraspinal muscles (MPM) in the ASP [ Time Frame: For the ASP technique, MPM measurement is planned to be done in between 30mins. and 40mins. time, for each participant, through study completion. ]
    Measured by ( [LPM+RPM]/2) in millimeters in the ASP

  5. Subcutaneous tissue (ST) measurements in the ASP [ Time Frame: For the ASP technique, ST measurement is planned to be done in between 40mins. and 50mins. time, for each participant, through study completion. ]
    the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the ASP

  6. The skin to spinous process (S-SP) measurements in the ASP [ Time Frame: For the ASP technique, S-SP measurement is planned to be done in between 50mins. and 1 hour(hr.) time, for each participant, through study completion. ]
    the depth measurement of the skin to spinous process in millimeters via ultrasonography in the ASP

  7. Interspinous gap opening (ISGO) measurement in the SFP [ Time Frame: For the SFP technique, ISGO measurement is planned to be done, right after NRS evaluation of the ASP, in between 1hr.10mins. and 1hr.20mins. time, for each participant, through study completion. ]
    the wideness measurement of the ISGO in millimeters via ultrasonography in the SFP

  8. Left paraspinal muscle (LPM) measurements in the SFP [ Time Frame: For the SFP technique, LPM measurement is planned to be done in between 1hr.20mins. and 1hr.30mins. time, for each participant, through study completion. ]
    the diameter measurement of the LPM in millimeters via ultrasonography in the SFP

  9. Right paraspinal muscle (RPM) measurements in the SFP [ Time Frame: For the SFP technique, RPM measurement is planned to be done in between 1hr.30mins. and 1hr.40mins. time, for each participant, through study completion. ]
    the diameter measurement of the RPM in millimeters via ultrasonography in the SFP

  10. The mean of bilateral paraspinal muscles (MPM) in the SFP [ Time Frame: For the SFP technique, MPM measurement is planned to be done in between 1hr.40mins. and 1hr.50mins. time, for each participant, through study completion. ]
    Measured by ( [LPM+RPM]/2) in millimeters in the SFP

  11. Subcutaneous tissue (ST) measurements in the SFP [ Time Frame: For the SFP technique, ST measurement is planned to be done in between 1hr.50mins. and 2hrs. time, for each participant, through study completion. ]
    the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the SFP

  12. The skin to spinous process (S-SP) measurements in the SFP [ Time Frame: For the SFP technique, S-SP measurement is planned to be done in between 2hrs. and 2hr.10mins. time, for each participant, through study completion. ]
    the depth measurement of the skin to spinous process in millimeters via ultrasonography in the SFP

  13. the change of ISGO (ISGO ASP-SFP) [ Time Frame: ISGO in the ASP is measured in the first 10mins., and ISGO in the SFP is measured in between 1hr.10 mins. and 1hr.20mins. time, through study completion. ]
    Measured by calculation; ([ISGO in the ASP in millimeters]-[ISGO in the SFP in millimeters])

  14. the change of LPM (LPM ASP-SFP) [ Time Frame: LPM in the ASP is measured in between 10mins. and 20mins. time, and LPM in the SFP is measured in between 1hr.20mins and 1hr.30mins. time, through study completion. ]
    Measured by calculation; ([LPM in ASP in millimeters]-[LPM in SFP in millimeters])

  15. the change of RPM (RPM ASP-SFP) [ Time Frame: RPM in the ASP is measured in between 20mins. and 30mins. time, and RPM in the SFP is measured in between 1hr.30mins. and 1hr.40mins. time, through study completion. ]
    Measured by calculation ([RPM in ASP in millimeters]-[RPM in SFP in millimeters])

  16. the change of MPM (MPM ASP-SFP) [ Time Frame: MPM in the ASP is measured in between 30mins. and 40mins. time, and MPM in the SFP is measured in between 1hr.40mins and 1hr.50mins. time, through study completion. ]
    Measured by calculation ([MPM in ASP in millimeters]-[MPM in SFP in millimeters])

  17. the change of ST (ST ASP-SFP) [ Time Frame: ST in the ASP is measured in between 40mins. and 50mins. time, and in the SFP is measured in between 1hr.50mins and 2hrs. time, through study completion. ]
    Measured by calculation ([ST in ASP in millimeters]-[ST in SFP in millimeters])

  18. the change of S-SP (S-SP ASP-SFP) [ Time Frame: S-SP in the ASP is measured in between 50mins. and 1hr. time, and S-SP in the SFP is measured in between 2 hrs. and 2hrs.10mins. time, through study completion. ]
    Measured by calculation ([S-SP in ASP in millimeters]-[S-SP in SFP in millimeters])


Secondary Outcome Measures :
  1. Comfort evaluation in the ASP via 5-point numerical rating scale (NRS) [ Time Frame: NRS measurement is planned to be done right after the ASP position in between 1hr. and 1hr.10mins. time, for each participant, through study completion. ]
    Comfort evaluation of the ASP technique is planned to be done by the participant right after USG. The 5-point NRS includes 5 scale. The minimum scale is"1" means poor, "2" means fair, "3" means good, "4" means very good, and the maximum scale is "5" means excellent.

  2. Comfort evaluation in the SFP via 5-point numerical rating scale (NRS) [ Time Frame: NRS measurement is planned to be done right after the SFP position in between 2hrs.10mins. and 2hrs.20mins. time, for each participant, through study completion. ]
    Comfort evaluation of the SFP technique is planned to be done by the participant right after USG. The 5-point NRS includes 5 scale. The minimum scale is"1" means poor, "2" means fair, "3" means good, "4" means very good, and the maximum scale is "5" means excellent.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healty and adult volunteers,
  • must be able to do the sitting fetal cross-legged position ( ASP ),
  • must be able to do the sitting fetal position ( SFP ).

Exclusion Criteria:

  • BMI higher than 40,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741465


Locations
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Turkey
Yeditepe University hospital
Istanbul, İçerenköy, Turkey
Sponsors and Collaborators
Yeditepe University
Investigators
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Principal Investigator: ferda kartufan

Publications:
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Responsible Party: Fatma Ferda Kartufan, Assistant Professor, Yeditepe University
ClinicalTrials.gov Identifier: NCT03741465     History of Changes
Other Study ID Numbers: YeditepeU
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Anatolian sitting position
sitting cross-legged position
sitting fetal position
ultrasonography
numerical rating scale