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Evaluation of Ultrasound (US) Assistance for Anesthesia Trainees for Caesarean Section Spinal Placement

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ClinicalTrials.gov Identifier: NCT01444638
Recruitment Status : Completed
First Posted : October 3, 2011
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):
Timothy Turkstra, Lawson Health Research Institute

Brief Summary:
Parturients receiving spinal anesthetic for Cesarean section will be randomized to have/not have pre-spinal ultrasound examination of their back.

Condition or disease Intervention/treatment Phase
Pregnancy Device: Ultrasound examination Not Applicable

Detailed Description:

Parturients receiving spinal anesthetic for elective Cesarean section will be randomized to have/not have pre-spinal ultrasound examination of their back, prior to spinal insertion by anesthesia trainees.

The hypothesis is that ultrasound visualization of the patient spinal spaces will allow junior residents to correctly place the spinal needle with fewer attempts.

The null hypothesis is that there is no difference in the primary outcome (number of attempts). i.e. the investigators hypothesize that the number of attempts is not affected by ultrasound assistance. The control group will undergo spinal anesthesia with manual palpation, the standard of care.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Evaluation of US Assistance for Anesthesia Trainees for Spinal Placement in Parturients Having Caesarean Section: A Randomized Control Trial
Study Start Date : January 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ultrasound
Trainees will receive pre-procedure U/S guided examination of the parturient's back.
Device: Ultrasound examination
Trainees will receive pre-procedure U/S guided examination of the parturient's back.
Other Name: M-turbo
No Intervention: Control
Control group. (Standard practice) Trainees will NOT receive pre-procedure U/S guided examination.



Primary Outcome Measures :
  1. Number of attempts at intrathecal needle tip placement during spinal anesthesia. [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. 1. Time to place spinal anesthetic (seconds), measured from introducer placement to confirmation of cerebral spinal fluid (CSF). [ Time Frame: Day 1 ]
  2. Space used for 1st attempt, as estimated by palpation or U/S [ Time Frame: Day 1 ]
  3. Number of spaces used [ Time Frame: Day 1 ]
  4. Dural depth (cm) [ Time Frame: Day 1 ]


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

Inclusion Criteria:

  1. Parturient scheduled for elective spinal anesthetic for caesarean section.
  2. Resident level PGY1 or PGY2.
  3. Resident experience between 2-25 spinal anesthetics.
  4. ASA 1-3 scheduled for elective sections

Exclusion Criteria:

  1. Parturient BMI > 40.
  2. Emergency C-section.
  3. Previous spinal surgery or scoliosis.
  4. Parturient refusal
  5. Resident refusal
  6. Multiple gestations

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): NCT01444638


Locations
Canada, Ontario
Victoria Hospital
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Timothy P Turkstra, M. Eng, MD UWO

Responsible Party: Timothy Turkstra, Assistant Professor, Staff Anesthesiologist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01444638     History of Changes
Other Study ID Numbers: R-10-594
17529 ( Other Identifier: REB )
First Posted: October 3, 2011    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013

Keywords provided by Timothy Turkstra, Lawson Health Research Institute:
pregnancy
Caesarian
section
spinal