Ultrasound Imaging of Neck Blood Vessels in Pregnant and Non-Pregnant Women

November 13, 2007 updated by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Internal Jugular Vein and Carotid Artery Anatomic Relation as Determined by Ultrasonography in Obstetric Patients

There is no data regarding success rates and incidence of carotid punctures during central venous cannulation (CVC) in the pregnant patients. We hypothesize that because of the anatomical and physiological changes associated with pregnancy, these patients are at higher risk of procedure failure and carotid puncture than the general population. The purpose of our study is to determine the success rate and incidence of carotid punctures using an ultrasound-simulated procedure in pregnant and non-pregnant patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is no data regarding success rates and incidence of carotid punctures during central venous cannulation (CVC) in pregnant patients. We hypothesize that because of the anatomical and physiological changes associated with pregnancy, these patients are at higher risk of procedure failure and carotid puncture than the general population. The purpose of our study is to determine the success rate and incidence of carotid punctures using an ultrasound-simulated procedure in pregnant and non-pregnant patients.

Pregnant patients and adult female volunteers (controls) were recruited. Subjects were placed supine with wedge under the right hip, and head turned 35 degrees to the left. Two different approaches for CVC, the central landmark and the palpatory approach were used. The ease of identification of the landmarks was noted. CVC was simulated using an ultrasound probe, on pre-marked points. Ultrasound images were obtained, within the same parasagittal plane, directed 30 degrees caudad, in a manner simulating how a syringe and needle would be placed for central venous cannulation. The investigator placing the probe was blinded to the image being generated. The vertical cursor of the ultrasound, which serves to delineate the path of a needle, was placed in the image. If the cursor intersects the vein, the attempt is considered successful. If the first attempt is not successful, the investigator placing the probe was asked to redirect the probe to the second and if necessary to the third marked point. This was done for each approach. If the cursor intersects the carotid artery, the attempt is considered an accident and no further attempts were made. In addition to determining the success rate and the incidence of carotid punctures, the relative position of vein and artery was studied in each patient. For each approach, the best image was recorded, and three experienced anesthesiologist scored the images for vein and artery degree of overlapping.

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant patients
  • Healthy non-pregnant female volunteers

Exclusion Criteria:

  • Urgent, emergent or hemodynamically unstable patients
  • Patients with known abnormal neck anatomy, previous surgery or trauma involving the neck, or prior cannulation of neck vessels

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Investigators

  • Principal Investigator: Jose CA Carvalho, MD PhD, Mount Sinai Hosiptal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

April 23, 2007

First Submitted That Met QC Criteria

April 23, 2007

First Posted (Estimate)

April 24, 2007

Study Record Updates

Last Update Posted (Estimate)

November 15, 2007

Last Update Submitted That Met QC Criteria

November 13, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06-04
  • 06-0217-E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy

Clinical Trials on ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe