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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464828
• Other study ID #: 06-04
• Secondary ID: 06-0217-E
• Status: Completed
• Phase: N/A
• First received: April 23, 2007
• Last updated: November 13, 2007
• Start date: November 2006
• Est. completion date: June 2007

Study information

• Verified date: November 2007
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Intervention

Procedure:
• Internal jugular vein cannulation

Device:
• ultrasound

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada,