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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03656978
Other study ID # zs-1338
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date March 8, 2019

Study information

Verified date September 2020
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess and improve the safety and success rate of vascular puncture and catheterization using ultrasound-guided methods.


Description:

Investigators hypothesized that (1) various ultrasound-guided methods had different performances of vascular puncture and catheterization, (2) certain risk factors influenced safety and success rate of vascular puncture and catheterization (3) implementation of protocols could improve the performances of ultrasound-guided vascular puncture and catheterization.


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date March 8, 2019
Est. primary completion date April 23, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age above 18 years old.

- Scheduled for selective surgery.

- Requirement of perioperative vascular puncture and catheterization.

- American standard of anesthesia level I-IV.

Exclusion Criteria:

- Contraindication to vascular puncture or catheterization.

- Occlusion or thrombosis of target vessel evaluated by ultrasound.

- Refuse or disagreement from participants.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
dynamic
Use the according methods in dynamic arm descriptions.
Regular-triangle
Use the according methods in regular-triangle arm descriptions.

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Fragou M, Gravvanis A, Dimitriou V, Papalois A, Kouraklis G, Karabinis A, Saranteas T, Poularas J, Papanikolaou J, Davlouros P, Labropoulos N, Karakitsos D. Real-time ultrasound-guided subclavian vein cannulation versus the landmark method in critical care patients: a prospective randomized study. Crit Care Med. 2011 Jul;39(7):1607-12. doi: 10.1097/CCM.0b013e318218a1ae. — View Citation

Gao YB, Yan JH, Ma JM, Liu XN, Dong JY, Sun F, Tang LW, Li J. Effects of long axis in-plane vs short axis out-of-plane techniques during ultrasound-guided vascular access. Am J Emerg Med. 2016 May;34(5):778-83. doi: 10.1016/j.ajem.2015.12.092. Epub 2016 Jan 6. — View Citation

Goh G, Tan C, Weinberg L. Dynamic ultrasound-guided, short axis, out-of-plane radial artery cannulation: the 'follow the tip' technique. Anaesth Intensive Care. 2013 May;41(3):431-2. — View Citation

Nakayama Y, Nakajima Y, Sessler DI, Ishii S, Shibasaki M, Ogawa S, Takeshita J, Shime N, Mizobe T. A novel method for ultrasound-guided radial arterial catheterization in pediatric patients. Anesth Analg. 2014 May;118(5):1019-26. doi: 10.1213/ANE.0000000000000164. — View Citation

Powell JT, Mink JT, Nomura JT, Levine BJ, Jasani N, Nichols WL, Reed J, Sierzenski PR. Ultrasound-guidance can reduce adverse events during femoral central venous cannulation. J Emerg Med. 2014 Apr;46(4):519-24. doi: 10.1016/j.jemermed.2013.08.023. Epub 2014 Jan 22. — View Citation

Reusz G, Csomos A. The role of ultrasound guidance for vascular access. Curr Opin Anaesthesiol. 2015 Dec;28(6):710-6. doi: 10.1097/ACO.0000000000000245. Review. — View Citation

Sethi S, Maitra S, Saini V, Samra T, Malhotra SK. Comparison of short-axis out-of-plane versus long-axis in-plane ultrasound-guided radial arterial cannulation in adult patients: a randomized controlled trial. J Anesth. 2017 Feb;31(1):89-94. doi: 10.1007/s00540-016-2270-6. Epub 2016 Oct 19. — View Citation

Ward F, Faratro R, McQuillan RF. Ultrasound-Guided Cannulation of the Hemodialysis Arteriovenous Access. Semin Dial. 2017 Jul;30(4):319-325. doi: 10.1111/sdi.12603. Epub 2017 May 9. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Successful rate without extra vascular damage Percentages of successful catheterization without vascular damage of posterior wall. Through study completion, an average of 1 year.
Secondary Successful rate at first attempt. Percentage of successful catheterization at first attempt without needle withdraw. Through study completion, an average of 1 year.
Secondary Time duration of catheterization. From beginning of needle puncture to finishing or failing catheterization. Through study completion, an average of 1 year.
Secondary Relative factors of successful catheterization without posterior wall damage. Relationship between independent variables (gender, age, BMI, BP, depth and so on) and successful catheterization without posterior wall damage. Through study completion, an average of 1 year.
Secondary The effect of depth to the successful catheterization without posterior wall puncture. The relationships between different depth of vascular anterior wall and successful catheterization without posterior wall puncture. Through study completion, an average of 1 year.
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