Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464828
Status:
COMPLETED
Last Update Posted:
2007-11-15
First Post:
2007-04-23
Brief Title:
Ultrasound Imaging of Neck Blood Vessels in Pregnant and Non-Pregnant Women
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Internal Jugular Vein and Carotid Artery Anatomic Relation as Determined by Ultrasonography in Obstetric Patients
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-0217-E | None | None | None |