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

NCT ID: NCT01444638

Last Updated: 2013-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ultrasound

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

Group Type EXPERIMENTAL

Ultrasound examination

Intervention Type DEVICE

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound examination

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

Intervention Type DEVICE

Other Intervention Names

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M-turbo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Timothy Turkstra

Assistant Professor, Staff Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timothy P Turkstra, M. Eng, MD

Role: PRINCIPAL_INVESTIGATOR

UWO

Locations

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Victoria Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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17529

Identifier Type: OTHER

Identifier Source: secondary_id

R-10-594

Identifier Type: -

Identifier Source: org_study_id

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