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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Timothy Turkstra, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01444638
First received: August 3, 2011
Last updated: January 12, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Pregnancy
Device: Ultrasound examination

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Evaluation of US Assistance for Anesthesia Trainees for Spinal Placement in Parturients Having Caesarean Section: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Number of attempts at intrathecal needle tip placement during spinal anesthesia. [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. Time to place spinal anesthetic (seconds), measured from introducer placement to confirmation of cerebral spinal fluid (CSF). [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Space used for 1st attempt, as estimated by palpation or U/S [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of spaces used [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Dural depth (cm) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 3, 2011
Last Updated: January 12, 2013
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014