Comparing Palpation Guided and Ultrasound Guided Arterial Line Placement

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01757314
First received: September 27, 2012
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

When surgery is performed under general anesthesia, a catheter is placed in a vein to administer drugs and saline. During major operations, an additional catheter is placed in an artery in order to measure the blood pressure closely and withdraw blood samples at frequent intervals for various laboratory tests. This arterial catheter is usually placed by feeling the patient's artery at the wrist and inserting the guide-needle in a blind fashion. This procedure, at times, leads to delays and failures due to an inability to feel the arterial pulsation well either due to the patients' anatomy or the anesthetic effect. This study will determine whether training Anesthesiology Residents in the use of ultrasound technology and its application in identifying an artery can prevent the problems associated with the conventional palpation technique. Our finding will lead to better and safer anesthetic management of patients presenting for a major surgical procedure. Furthermore, the finding will help us in introducing the education and training of ultrasound-guided arterial catheter placement in our Residency Program.

The investigators propose to follow anesthesia residents over a course of 3 years assessing their skill level for both palpation and ultrasound technique.


Condition Intervention
Surgeries Requiring Arterial Lines
Behavioral: ultrasound technique
Other: palpation technique

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study Comparing Palpation Guided and Ultrasound Guided Arterial Catheter Placement by Anesthesiology Residents in Training

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • time to successful placement of catheter [ Time Frame: residents to be timed over 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CA 1 and 2 anethesia residents
palpation technique
Other: palpation technique
placement of a line via palpation technique
Ca1 and 2 residents
ultrasound guided technique
Behavioral: ultrasound technique
instruction in the ultrasound technique

Detailed Description:

This is an updated study on a previous IRB-approved research (0120070296) which was terminated prior to conclusion as the principal investigator terminated his employment at the UNDNJ. An arterial catheter is routinely placed immediately following induction of anesthesia, in major operative procedures, in order to measure blood pressure continuously, perform frequent blood-gas analysis and withdraw blood for repeated laboratory testing. The arterial catheter is traditionally placed blindly by palpating the radial artery of the patient. This way of placing a radial artery catheter can encounter delay or failure due to conditions such as obesity, arteriosclerosis, arterial spasm and anesthesia-induced hypotension. Our study will compare the performance of Anesthesiology Residents in placing an arterial catheter by the traditional palpation-guided technique and by the ultrasound-guided technique after training in ultrasound usage. The comparison will utilize the following parameters:

  • Time taken to successfully place a catheter
  • Number of attempts needed to place a catheter
  • Number of puncture site changes encountered
  • Failure rate of the resident with each technique
  • The need for replacement of the catheter during surgery The data collection will be done by an independent observer, who is not a member of the anesthesia care team or research team. The Residents performing the catheter placement will not be members of the research team and will not have access to the data. If the Resident fails to place the catheter, the attending anesthesiologist will rescue by placing the arterial catheter himself by a method of his choice. In the previous study, there was a trend toward a reduced failure rate and a decreased time for insertion with the ultrasound technique. In this study, the investigators will introduce the research to the first-year Residents and repeat the exercise during their second and third year of training in a longitudinal fashion to assess the progress during anesthesia training. The investigators plan to enroll eight residents from the first-year class. Each resident will perform eight arterial catheter placements with each technique. In addition, compared to the previous study, a more advanced ultrasound machine will be used which will provide better visualization of the radial artery.
  Eligibility

Ages Eligible for Study:   25 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

CA 1 and CA 2 residents assigned to surgical patients who require arterial lines due to complex surgical procedures

Criteria

Inclusion Criteria:

  • resident in training is agreeable to consent

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757314

Contacts
Contact: Ross Moore, MD 973 972-5254 rm5795@earthlink.net
Contact: Catherine Schoenberg, BSN 973 972-7477 shoenbce@umdnj.edu

Locations
United States, New Jersey
University Hospital Recruiting
Newark, New Jersey, United States, 07101
Contact: Ross Moore, MD    973-972-5254    rm5795@earthlink.net   
Principal Investigator: Ross Moore, MD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Anesthesia, Ross Moore, MD, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01757314     History of Changes
Other Study ID Numbers: 2012001193
Study First Received: September 27, 2012
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
arterial lines

ClinicalTrials.gov processed this record on July 22, 2014