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

NCT ID: NCT00464828

Last Updated: 2007-11-15

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

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy

Keywords

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Central venous cannulation Internal jugular vein Ultrasound Obstetrics

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Internal jugular vein cannulation

Intervention Type PROCEDURE

ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Jose CA Carvalho, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hosiptal

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Siddiqui N, Goldszmidt E, Haque SU, Carvalho JC. Ultrasound simulation of internal jugular vein cannulation in pregnant and non-pregnant women. Can J Anaesth. 2010 Nov;57(11):966-72. doi: 10.1007/s12630-010-9374-5. Epub 2010 Sep 10.

Reference Type DERIVED
PMID: 20830543 (View on PubMed)

Other Identifiers

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06-0217-E

Identifier Type: -

Identifier Source: secondary_id

06-04

Identifier Type: -

Identifier Source: org_study_id