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出境医 / 临床实验 / Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients

Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients

Study Description
Brief Summary:
In this prospective, randomized, open-labeled study, the intensive care patients will be selected for ultrasound-guided cannulation of the radial artery in three different regions. Patients will be divided into three groups with simple randomization. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Whether there is a difference in the duration of use of arterial cannula, first entry success rates, duration of intervention, number of procedures, the number of cannulas used and the effects on early and late complications and advantages between the groups will be investigated.

Condition or disease Intervention/treatment Phase
Arterial Cannulation in Intensive Care Unit Catheterization, Peripheral Radial Artery Procedure: The radial artery cannulation over 2 cm of the wrist Procedure: The radial artery cannulation in the distal 3/4 area of the forearm Procedure: The radial artery cannulation in the distal 1/2 area of the forearm Not Applicable

Detailed Description:

In patients requiring frequent arterial blood gas sampling in the intensive care unit and in cases requiring continuous blood pressure monitoring, arterial cannulation is preferred. The use of USG has also become widespread in anesthesia practice. It is supported by studies that USG-guided interventions cause fewer complications compared to classical methods and reduce intervention time. USG-guided arterial catheterization method is based on the principle of direct visualization of the artery and catheter via USG. In this technique, the catheter and the needle tip are displayed simultaneously with the USG guided to the artery lumen. Imaging of anatomical structures with USG has resulted in a reduction of complications and shortening of the processing time. In the USG screen, adjacent anatomical formations such as veins and nerve structures are simultaneously displayed. This reduces the risk of complications.

Two different techniques are used for USG mediated radial artery cannulation. The first one is the in-plane technique, which forms the long axis image of the arteries by positioning the USG probe to parallel to the vein, and the second is the out-of-plane technique, which forms a short axis image with the probe positioned perpendicular to the arteries.

The ideal location of radial artery catheterization with USG or the advantages/disadvantages of the catheterization zone are not available.

In this randomized prospective and open-label study, patients will be divided into three groups. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Comparison of these three groups, in terms of duration of use of arterial cannula, initial entry success rates, duration of intervention, number of procedures used, number of cannulas used and effects on early and late complications, and advantages if any is intended.

Patients will be randomly distributed to three groups. Diagnosis, age, sex, height, weight, and body mass index of the patients will be recorded. The random distribution of obese patients to groups will be ensured. Allen test will be done to the patients before the intervention. Radial artery catheterization will be applied only to patients with the collateral flow. Each group will be measured and recorded before, during and after the intervention. Before the intervention, local anesthetic infiltration will be applied and asepsis will be provided. Early complications (such as hematoma, hemorrhage) and late complications (such as circulatory disorders) will be observed and recorded.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
Actual Study Start Date : July 30, 2019
Actual Primary Completion Date : September 10, 2019
Actual Study Completion Date : October 1, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: The first group
The radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group.
 Procedure: The radial artery cannulation over 2 cm of the wrist
The radial artery catheterization performed as short axis out-of-plane with USG over 2 cm of the wrist.
Experimental: The second group
The radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention.
 Procedure: The radial artery cannulation in the distal 3/4 area of the forearm
The radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention.
Experimental: The third group
The radial artery catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane intervention.
 Procedure: The radial artery cannulation in the distal 1/2 area of the forearm
The radial artery catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane intervention.
Outcome Measures
Primary Outcome Measures :
  1. Duration of Use of Arterial Cannula [ Time Frame: During Procedure ]
    From the time arterial cannula is successfully inserted until cannula cannot use


Secondary Outcome Measures :
  1. Initial Entry Success Rates [ Time Frame: During procedure ]
    Success or fail of initial entry

  2. Duration of Intervention [ Time Frame: During procedure ]
    Time from the beginning of procedure and successful cannulation of radial artery

  3. Number of Punctures [ Time Frame: During procedure ]
    Count of punctures until successful artery cannulation

  4. Early Complications [ Time Frame: During procedure ]
    Complications seen during procedure

  5. Late Complications [ Time Frame: Up to 7 days ]
    Complications seen after successful completion of artery cannulation


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admission of the first degree relatives of the patients and if the patient can give consent
  • Patients over 18
  • Non-pregnant patients
  • Patients without inotropic/vasopressor support
  • Patients who do not have contraindications for radial artery cannulation (thrombosis in the distal region, a focus of infection at the site of entry, lack of adequate collateral flow in the Allen test, peripheral vascular diseases [eg, Raynaud's disease)]

Exclusion Criteria:

  • Patient/Patient's first degree relatives refuse to work
  • Patients under 18
  • Pregnant patients
  • Patients with contraindications for radial artery cannulation (thrombosis in the distal region, a focus of infection at the site of entry, lack of adequate collateral flow in the Allen test, peripheral vascular diseases [eg, Raynaud's disease)]
  • Patient's inotropic/vasopressor support
Contacts and Locations

Locations
Layout table for location information
Turkey
Izmir Bozyaka Training and Research Hospital
Izmir, Karabaglar, Turkey, 35170
Sponsors and Collaborators
Bozyaka Training and Research Hospital
Investigators
Layout table for investigator information
Study Director: Zeki T. TEKGUL, Assoc. Prof. Izmir Bozyaka Training and Research Hospital
Tracking Information
First Submitted Date  ICMJE June 15, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE July 30, 2019
Actual Primary Completion Date September 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019) 		Duration of Use of Arterial Cannula [ Time Frame: During Procedure ]
From the time arterial cannula is successfully inserted until cannula cannot use
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • Initial Entry Success Rates [ Time Frame: During procedure ]
    Success or fail of initial entry
  • Duration of Intervention [ Time Frame: During procedure ]
    Time from the beginning of procedure and successful cannulation of radial artery
  • Number of Punctures [ Time Frame: During procedure ]
    Count of punctures until successful artery cannulation
  • Early Complications [ Time Frame: During procedure ]
    Complications seen during procedure
  • Late Complications [ Time Frame: Up to 7 days ]
    Complications seen after successful completion of artery cannulation
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 Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
Official Title  ICMJE Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
Brief Summary In this prospective, randomized, open-labeled study, the intensive care patients will be selected for ultrasound-guided cannulation of the radial artery in three different regions. Patients will be divided into three groups with simple randomization. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Whether there is a difference in the duration of use of arterial cannula, first entry success rates, duration of intervention, number of procedures, the number of cannulas used and the effects on early and late complications and advantages between the groups will be investigated.
Detailed Description

In patients requiring frequent arterial blood gas sampling in the intensive care unit and in cases requiring continuous blood pressure monitoring, arterial cannulation is preferred. The use of USG has also become widespread in anesthesia practice. It is supported by studies that USG-guided interventions cause fewer complications compared to classical methods and reduce intervention time. USG-guided arterial catheterization method is based on the principle of direct visualization of the artery and catheter via USG. In this technique, the catheter and the needle tip are displayed simultaneously with the USG guided to the artery lumen. Imaging of anatomical structures with USG has resulted in a reduction of complications and shortening of the processing time. In the USG screen, adjacent anatomical formations such as veins and nerve structures are simultaneously displayed. This reduces the risk of complications.

Two different techniques are used for USG mediated radial artery cannulation. The first one is the in-plane technique, which forms the long axis image of the arteries by positioning the USG probe to parallel to the vein, and the second is the out-of-plane technique, which forms a short axis image with the probe positioned perpendicular to the arteries.

The ideal location of radial artery catheterization with USG or the advantages/disadvantages of the catheterization zone are not available.

In this randomized prospective and open-label study, patients will be divided into three groups. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Comparison of these three groups, in terms of duration of use of arterial cannula, initial entry success rates, duration of intervention, number of procedures used, number of cannulas used and effects on early and late complications, and advantages if any is intended.

Patients will be randomly distributed to three groups. Diagnosis, age, sex, height, weight, and body mass index of the patients will be recorded. The random distribution of obese patients to groups will be ensured. Allen test will be done to the patients before the intervention. Radial artery catheterization will be applied only to patients with the collateral flow. Each group will be measured and recorded before, during and after the intervention. Before the intervention, local anesthetic infiltration will be applied and asepsis will be provided. Early complications (such as hematoma, hemorrhage) and late complications (such as circulatory disorders) will be observed and recorded.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Arterial Cannulation in Intensive Care Unit
  • Catheterization, Peripheral
  • Radial Artery
Intervention  ICMJE
  • Procedure: The radial artery cannulation over 2 cm of the wrist
    The radial artery catheterization performed as short axis out-of-plane with USG over 2 cm of the wrist.
  • Procedure: The radial artery cannulation in the distal 3/4 area of the forearm
    The radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention.
  • Procedure: The radial artery cannulation in the distal 1/2 area of the forearm
    The radial artery catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane intervention.
Study Arms  ICMJE
  • Active Comparator: The first group
    The radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group.
    Intervention: Procedure: The radial artery cannulation over 2 cm of the wrist
  • Experimental: The second group
    The radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention.
    Intervention: Procedure: The radial artery cannulation in the distal 3/4 area of the forearm
  • Experimental: The third group
    The radial artery catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane intervention.
    Intervention: Procedure: The radial artery cannulation in the distal 1/2 area of the forearm
Publications *
  • Hansen MA, Juhl-Olsen P, Thorn S, Frederiksen CA, Sloth E. Ultrasonography-guided radial artery catheterization is superior compared with the traditional palpation technique: a prospective, randomized, blinded, crossover study. Acta Anaesthesiol Scand. 2014 Apr;58(4):446-52. doi: 10.1111/aas.12299. Epub 2014 Mar 3.
  • Quan Z, Tian M, Chi P, Cao Y, Li X, Peng K. Modified short-axis out-of-plane ultrasound versus conventional long-axis in-plane ultrasound to guide radial artery cannulation: a randomized controlled trial. Anesth Analg. 2014 Jul;119(1):163-9. doi: 10.1213/ANE.0000000000000242.
  • Levin PD, Sheinin O, Gozal Y. Use of ultrasound guidance in the insertion of radial artery catheters. Crit Care Med. 2003 Feb;31(2):481-4.
  • Shiver S, Blaivas M, Lyon M. A prospective comparison of ultrasound-guided and blindly placed radial arterial catheters. Acad Emerg Med. 2006 Dec;13(12):1275-9. Epub 2006 Nov 1.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2019) 		94
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2019) 		90
Actual Study Completion Date  ICMJE October 1, 2019
Actual Primary Completion Date September 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Admission of the first degree relatives of the patients and if the patient can give consent
  • Patients over 18
  • Non-pregnant patients
  • Patients without inotropic/vasopressor support
  • Patients who do not have contraindications for radial artery cannulation (thrombosis in the distal region, a focus of infection at the site of entry, lack of adequate collateral flow in the Allen test, peripheral vascular diseases [eg, Raynaud's disease)]

Exclusion Criteria:

  • Patient/Patient's first degree relatives refuse to work
  • Patients under 18
  • Pregnant patients
  • Patients with contraindications for radial artery cannulation (thrombosis in the distal region, a focus of infection at the site of entry, lack of adequate collateral flow in the Allen test, peripheral vascular diseases [eg, Raynaud's disease)]
  • Patient's inotropic/vasopressor support
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04001764
Other Study ID Numbers  ICMJE direnctez
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bozyaka Training and Research Hospital
Study Sponsor  ICMJE Bozyaka Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Zeki T. TEKGUL, Assoc. Prof. Izmir Bozyaka Training and Research Hospital
PRS Account Bozyaka Training and Research Hospital
Verification Date December 2019

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

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