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Target Sign vs Palpation for Radial Arterial Line Placement

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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

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.


Condition or disease Intervention/treatment Phase
Radial Artery Cannulation Procedure: arterial line placement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Dynamic Need Tip Positioning With Ultrasound Versus Palpation Technique for Radial Artery Cannulation: A Prospective Randomized Controlled Trial
Actual Study Start Date : May 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: palpation
participants who are randomized to have radial arterial cannulation via palpation technique
Procedure: arterial line placement
radial arterial cannulation placed via palpation or ultrasound technique

Active Comparator: ultrasound
participants who are randomized to have radial arterial cannulation via a new ultrasound technique
Procedure: arterial line placement
radial arterial cannulation placed via palpation or ultrasound technique




Primary Outcome Measures :
  1. first pass success [ Time Frame: 5 minutes ]
    placement of arterial cannula in 5 minutes after touching the wrist


Secondary Outcome Measures :
  1. overall success [ Time Frame: 5 minutes ]
    successful arterial cannulation after any number of passes as long as it is within 5 minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557828


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
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Responsible Party: Roy K. Kiberenge, Associate- Physician, University of Iowa
ClinicalTrials.gov Identifier: NCT02557828    
Other Study ID Numbers: 201505705
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: June 2017