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Target Sign vs Palpation for Radial Arterial Line Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557828
Recruitment Status : Terminated (Principal Investigator retired)
First Posted : September 23, 2015
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Roy K. Kiberenge, University of Iowa

Tracking Information
First Submitted Date  ICMJE September 22, 2015
First Posted Date  ICMJE September 23, 2015
Last Update Posted Date June 2, 2017
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
first pass success [ Time Frame: 5 minutes ]
placement of arterial cannula in 5 minutes after touching the wrist
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
overall success [ Time Frame: 5 minutes ]
successful arterial cannulation after any number of passes as long as it is within 5 minutes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Target Sign vs Palpation for Radial Arterial Line Placement
Official Title  ICMJE Dynamic Need Tip Positioning With Ultrasound Versus Palpation Technique for Radial Artery Cannulation: A Prospective Randomized Controlled Trial
Brief Summary

Invasive blood pressure monitoring is achieved by cannulating an artery and transducing the pressure. During arterial cannulation the artery can be located by palpation, but use of ultrasound has increased the success rate of cannulation. A new ultrasound technique for vascular cannulation (dynamic needle tip positioning) has been described. Investigators aim to compare this technique to the palpation technique for arterial cannulation. Investigators hypothesize that the use of this novel ultrasound technique will result in a higher first attempt success rate and overall success compared to palpation.

Investigators plan to enroll 310 patients in this study. The participants in the study will have been deemed by the attending anesthesiologist to require a radial arterial line for the operation and thus the research protocol will not involve a deviation from the standard of care.

Detailed Description

Participants will be brought to the main operating rooms. The patient will not be required to do anything different than if they were not enrolled in the study. The anesthesiologist will be asked to confirm that the patient still requires an arterial line. The patient will be randomized either to palpation or ultrasound group. Patients would be placed in supine position on the operating room table and all regular monitors (electrocardiogram, pulse oximeter, non-invasive blood pressure) applied. After preoxygenation, the patient would be induced and the airway secured. For those requiring an arterial catheter before induction of general anesthesia, subcutaneous lidocaine will be used to anesthetize the planned puncture site.

The arms would be abducted and the decision on which side to place the arterial line will be determined by the operator after palpation or scanning the wrists with ultrasound. An ultrasound image of the radial artery to be cannulated will be obtained. A wrist roll would then be placed under the wrist and the hand secured with tape. The wrist would then be prepped with chlorhexidine and sterile towels placed around the prepped site. Timing would begin once the ultrasound or the operator fingers touch the prepped wrist. For those randomized to ultrasound, a Sonosite linear ultrasound probe would then be used to locate the radial artery. After satisfactory position is obtained, a 20 ga angiocath 45mm long would be used to puncture the artery and then would be advanced until the tip appears on the ultrasound view. When this happens the ultrasound is advanced about 2mm proximal along the artery. The needle is advanced until the tip is again visualized. This is repeated until the needle tip is in the lumen of the radial artery. At this point the needle is sequentially advanced in the lumen of the artery in small steps under ultrasound vision and then the cannula is advanced over the needle. The needle core is then retracted and the transducer is connected to the cannula. If the first attempt is unsuccessful, then more attempts may be made until 5 minutes elapse. Success is defined as arterial cannulation as shown by an arterial waveform that is obtained within 5 minutes of touching the prepped skin with an ultrasound probe or the operator fingers. After that the operator may use the arterial cannulation method of choice or decide to change to the other wrist.

For the palpation method, the radial artery would be palpated and then a 20 ga angiocath used to puncture the artery. After a return of blood in the catheter an attempt will be made to advance the catheter over the needle core. If this is not successful, the operator can make multiple attempts until 5 minutes elapse. After this time, the operator can use any desired method to cannulate the artery and may also decide to use the other wrist.

Investigators will record the successful first pass cannulation, and time to cannulate the vessel. Other measures will be number of attempts, number of catheters, radial artery depth, radial artery diameter, blood pressure, heart rate, and failure rate. Other data that will be recorded will include patient age, gender, weight, height , body mass index, and history of peripheral vascular disease, and diabetes.

Patients will not require any followup for the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Radial Artery Cannulation
Intervention  ICMJE Procedure: arterial line placement
radial arterial cannulation placed via palpation or ultrasound technique
Study Arms  ICMJE
  • Active Comparator: palpation
    participants who are randomized to have radial arterial cannulation via palpation technique
    Intervention: Procedure: arterial line placement
  • Active Comparator: ultrasound
    participants who are randomized to have radial arterial cannulation via a new ultrasound technique
    Intervention: Procedure: arterial line placement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 22, 2015)
260
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • needing radial arterial cannulation intraoperatively

Exclusion Criteria:

  • refusal to consent
  • minors
  • incarcerated individuals
  • radial cannulation within past month
  • negative modified Allen's test
  • shock
  • non-English speaking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02557828
Other Study ID Numbers  ICMJE 201505705
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roy K. Kiberenge, University of Iowa
Study Sponsor  ICMJE University of Iowa
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Iowa
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP