NCT01444638

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 3, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

1.7 years

First QC Date

August 3, 2011

Last Update Submit

January 12, 2013

Conditions

Pregnancy

Keywords

pregnancyCaesariansectionspinal

Outcome Measures

Primary Outcomes (1)

  • Number of attempts at intrathecal needle tip placement during spinal anesthesia.

    Day 1

Secondary Outcomes (4)

  • 1. Time to place spinal anesthetic (seconds), measured from introducer placement to confirmation of cerebral spinal fluid (CSF).

    Day 1

  • Space used for 1st attempt, as estimated by palpation or U/S

    Day 1

  • Number of spaces used

    Day 1

  • Dural depth (cm)

    Day 1

Study Arms (2)

Ultrasound

EXPERIMENTAL

Trainees will receive pre-procedure U/S guided examination of the parturient's back.

Device: Ultrasound examination

Control

NO INTERVENTION

Control group. (Standard practice) Trainees will NOT receive pre-procedure U/S guided examination.

Interventions

Ultrasound examinationDEVICE

Trainees will receive pre-procedure U/S guided examination of the parturient's back.

Also known as: M-turbo
Ultrasound

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Parturient BMI \> 40.
  • Emergency C-section.
  • Previous spinal surgery or scoliosis.
  • Parturient refusal
  • Resident refusal
  • Multiple gestations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Hospital

London, Ontario, N6A5A5, Canada

Location

Study Officials

  • Timothy P Turkstra, M. Eng, MD

    UWO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Staff Anesthesiologist

Study Record Dates

First Submitted

August 3, 2011

First Posted

October 3, 2011

Study Start

January 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

CA(1)