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Ultrasound Imaging of Neck Blood Vessels in Pregnant and Non-Pregnant Women
This study has been completed.
Sponsored by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Information provided by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00464828
  Purpose

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.


Condition Intervention
Pregnancy
Procedure: Internal jugular vein cannulation
Device: ultrasound

MedlinePlus related topics: Anatomy Ultrasound
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Internal Jugular Vein and Carotid Artery Anatomic Relation as Determined by Ultrasonography in Obstetric Patients

Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Enrollment: 156
Study Start Date: November 2006
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464828

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Jose CA Carvalho, MD PhD Mount Sinai Hosiptal
  More Information

Study ID Numbers: 06-04, 06-0217-E
Study First Received: April 23, 2007
Last Updated: November 13, 2007
ClinicalTrials.gov Identifier: NCT00464828  
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Central venous cannulation
Internal jugular vein
Ultrasound
Obstetrics

ClinicalTrials.gov processed this record on January 16, 2009