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Ultrasound-image Guided Versus Doppler Guided Versus Palpation Technique for Arterial Cannulation in Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01276171
First Posted: January 13, 2011
Last Update Posted: June 26, 2017
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.
Information provided by (Responsible Party):
Kenichi Ueda, University of Iowa
Results First Submitted: January 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anesthesia
Interventions: Procedure: Ultrasound
Procedure: Doppler
Procedure: Palpation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ultrasound

Participants will place arterial line using ultrasound technique

Ultrasound: Participants will place arterial line using ultrasound technique

Doppler

Participants will place arterial line using doppler technique

Doppler: Participants will place arterial line using doppler technique

Palpation

Participants will place arterial line using palpation technique

Palpation: Participants will place arterial line using Palpation technique


Participant Flow:   Overall Study
    Ultrasound   Doppler   Palpation
STARTED   249   244   256 
COMPLETED   249   244   256 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ultrasound

Participants will place arterial line using ultrasound technique

Ultrasound: Participants will place arterial line using ultrasound technique

Doppler

Participants will place arterial line using doppler technique

Doppler: Participants will place arterial line using doppler technique

Palpation

Participants will place arterial line using palpation technique

Palpation: Participants will place arterial line using Palpation technique

Total Total of all reporting groups

Baseline Measures
   Ultrasound   Doppler   Palpation   Total 
Overall Participants Analyzed 
[Units: Participants]
 249   244   256   749 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      148  59.4%      144  59.0%      157  61.3%      449  59.9% 
>=65 years      101  40.6%      100  41.0%      99  38.7%      300  40.1% 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 60 
 (48 to 71) 
 61 
 (51 to 72) 
 59 
 (50 to 70) 
 60 
 (50 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      106  42.6%      107  43.9%      106  41.4%      319  42.6% 
Male      143  57.4%      137  56.1%      150  58.6%      430  57.4% 
Region of Enrollment 
[Units: Participants]
       
United States   249   244   256   749 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   First Attempt Success Rate With 3 Different Technique   [ Time Frame: 5 minutes ]

2.  Secondary:   Time to Successful Cannulation   [ Time Frame: 5 minutes ]

3.  Secondary:   Total Success Rate   [ Time Frame: 5 min ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kenichi Ueda
Organization: University of Iowa Hospitals and Clinics
phone: 319-356-2633 ext 48517
e-mail: kenichi-ueda@uiowa.edu



Responsible Party: Kenichi Ueda, University of Iowa
ClinicalTrials.gov Identifier: NCT01276171     History of Changes
Other Study ID Numbers: 201001776
First Submitted: January 11, 2011
First Posted: January 13, 2011
Results First Submitted: January 12, 2017
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017