Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
99 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-12-31
Study Completion Date
2016-05-31
Brief Summary
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The purpose of this study is to compare the effectiveness and safety of the installation of femoral central venous catheter (CVC) ultrasound-guided real-time 2D versus the landmark method
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Detailed Description
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STUDY DESIGN Multicenter prospective randomized study in pediatric intensive care units of the Roberto del Rio's hospital and Exequiel González Cortés' hospital. Patients from entering the study between the months of January/2015 to December/2015, after signing informed by their parents or legal guardian consent, this will be implemented by the resident
PATIENTS Previous studies report an average success rate of 50% on the first attempt in the anatomical method, both children and adults. Sample size is determined to improve on a 30% success rate using the ultrasound method. For a power of 80% in relation to success at the first attempt and with a confidence level of 95%, a total of 50 patients per branch is determined.
Method of randomization Using computer program the patient leaving 50 patients in the group with the anatomical method, and 50 patients in the ultrasound method are randomized .
OPERATOR Both installation landmark and ultrasound guidance will be performed by 3 or 4 team doctors resident in each center , who count on ≥ 3 years of experience in ICU and training in ultrasound-guided access .
DEFINITIONS
* Successful cannulation: is considered successful installation when the guide is installed without difficulty in femoral vein.
* Cannulation the first try: is considered successful when installing the CVC is accomplished by first transcutaneous passage to the glass needle .
* Attempt to cannulation: considered attempt the passage of the needle without removing or redirect moving forward. Each successive removal or redirection with a forward motion is considered more a try.
* Arterial puncture: Arterial puncture aspiration involves pulsatile arterial blood .
* Rescue: After the fifth attempt in the landmark method will change the method under ultrasound guidance and is considered not successful cannulation. Result of not having puncture site is changed.
INSTALLATION METHOD
* Anatomical : In supine with external rotation and abduction of the lower extremity is located by palpating the femoral artery in the femoral triangle and punctured medial to this towards the navel to have reflux of venous blood.
* Guided by ultrasound: Ultrasound is performed to verify the presence and proper position of a target vessel before puncturing the skin followed by real-time ultrasound to guide the needle tip during the lancing process.
OUTCOME It was considered as primary outcome main installation on the first try , and secondary outcome cannulation success, number of attempts and , as a complication of the procedure, arterial puncture. Rescue will be used after the 5th attempt in the anatomical method that will change the method under ultrasound guidance . Failure to gain access shall be considered as successful cannulation and change of puncture site
STATISTICAL ANALYSIS For statistical analysis the Stata 12.0 software was used. Continuous variables were analyzed using descriptive analysis of normal distribution with means and standard deviations , and continuous variables were not normally distributed and qualitative medians and percentiles. For the primary outcome will be used to varying dicomtómic Chi square method
PATIENTS Previous studies report an average success rate of 50% on the first attempt in the anatomical method, both children and adults. Sample size is determined to improve on a 30% success rate using the ultrasound method. For a power of 80% in relation to success at the first attempt and with a confidence level of 95%, a total of 50 patients per branch is determined.
Method of randomization Using computer program the patient leaving 50 patients in the group with the anatomical method, and 50 patients in the ultrasound method are randomized .
OPERATOR Both installation landmark and ultrasound guidance will be performed by 3 or 4 team doctors resident in each center , who count on ≥ 3 years of experience in ICU and training in ultrasound-guided access .
DEFINITIONS
* Successful cannulation: is considered successful installation when the guide is installed without difficulty in femoral vein.
* Cannulation the first try: is considered successful when installing the CVC is accomplished by first transcutaneous passage to the glass needle .
* Attempt to cannulation: considered attempt the passage of the needle without removing or redirect moving forward. Each successive removal or redirection with a forward motion is considered more a try.
* Arterial puncture: Arterial puncture aspiration involves pulsatile arterial blood .
* Rescue: After the fifth attempt in the landmark method will change the method under ultrasound guidance and is considered not successful cannulation. Result of not having puncture site is changed.
INSTALLATION METHOD
* Anatomical : In supine with external rotation and abduction of the lower extremity is located by palpating the femoral artery in the femoral triangle and punctured medial to this towards the navel to have reflux of venous blood.
* Guided by ultrasound: Ultrasound is performed to verify the presence and proper position of a target vessel before puncturing the skin followed by real-time ultrasound to guide the needle tip during the lancing process.
OUTCOME It was considered as primary outcome main installation on the first try , and secondary outcome cannulation success, number of attempts and , as a complication of the procedure, arterial puncture. Rescue will be used after the 5th attempt in the anatomical method that will change the method under ultrasound guidance . Failure to gain access shall be considered as successful cannulation and change of puncture site
STATISTICAL ANALYSIS For statistical analysis the Stata 12.0 software was used. Continuous variables were analyzed using descriptive analysis of normal distribution with means and standard deviations , and continuous variables were not normally distributed and qualitative medians and percentiles. For the primary outcome will be used to varying dicomtómic Chi square method
Conditions
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Child
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Landmark method
installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.
access will be through the femoral vein only
Group Type
OTHER
central venous catheter
Intervention Type
DEVICE
installation of Central venous catheter landmark guided
Ultrasound method
installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only
Group Type
ACTIVE_COMPARATOR
central venous catheter
Intervention Type
DEVICE
installation of Central venous catheter ultrasound guided
Interventions
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central venous catheter
installation of Central venous catheter ultrasound guided
Intervention Type
DEVICE
central venous catheter
installation of Central venous catheter landmark guided
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Need for central venous access
Exclusion Criteria
* More than 15 years.
* Local infection at the puncture site
* Anatomical and / or functional vascular alteration known
* Local infection at the puncture site
* Anatomical and / or functional vascular alteration known
Minimum Eligible Age
1 Week
Maximum Eligible Age
15 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Chile
OTHER
Sponsor Role
lead
Responsible Party
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Pietro Pietroboni Fuster
Medico Pediatra
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Pietro F Pietroboni, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chile
Cristian Carvajal, MD, Mg
Role: STUDY_DIRECTOR
Hospital Roberto del Río
Locations
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Hospital Exequiel González Cortés
Santiago, Santiago Metropolitan, Chile
Site Status
Hospital Roberto del Rio
Santiago, Santiago Metropolitan, Chile
Site Status
Countries
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Chile
References
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Wu SY, Ling Q, Cao LH, Wang J, Xu MX, Zeng WA. Real-time two-dimensional ultrasound guidance for central venous cannulation: a meta-analysis. Anesthesiology. 2013 Feb;118(2):361-75. doi: 10.1097/ALN.0b013e31827bd172.
Reference Type
BACKGROUND
National Institute for Clinical Excellence. Guidance on the use of ultrasound locating devices for placing central venous catheters. Technology Appraisal Guidance-No.49, 2002:1-21
Reference Type
BACKGROUND
American Society of Anesthesiologists Task Force on Central Venous Access; Rupp SM, Apfelbaum JL, Blitt C, Caplan RA, Connis RT, Domino KB, Fleisher LA, Grant S, Mark JB, Morray JP, Nickinovich DG, Tung A. Practice guidelines for central venous access: a report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2012 Mar;116(3):539-73. doi: 10.1097/ALN.0b013e31823c9569. No abstract available.
Reference Type
BACKGROUND
Johnson EM, Saltzman DA, Suh G, Dahms RA, Leonard AS. Complications and risks of central venous catheter placement in children. Surgery. 1998 Nov;124(5):911-6.
Reference Type
BACKGROUND
Karapinar B, Cura A. Complications of central venous catheterization in critically ill children. Pediatr Int. 2007 Oct;49(5):593-9. doi: 10.1111/j.1442-200X.2007.02407.x.
Reference Type
BACKGROUND
Casado-Flores J, Barja J, Martino R, Serrano A, Valdivielso A. Complications of central venous catheterization in critically ill children. Pediatr Crit Care Med. 2001 Jan;2(1):57-62. doi: 10.1097/00130478-200101000-00012.
Reference Type
BACKGROUND
Hilty WM, Hudson PA, Levitt MA, Hall JB. Real-time ultrasound-guided femoral vein catheterization during cardiopulmonary resuscitation. Ann Emerg Med. 1997 Mar;29(3):331-6; discussion 337. doi: 10.1016/s0196-0644(97)70344-5.
Reference Type
BACKGROUND
Verghese ST, McGill WA, Patel RI, Sell JE, Midgley FM, Ruttimann UE. Ultrasound-guided internal jugular venous cannulation in infants: a prospective comparison with the traditional palpation method. Anesthesiology. 1999 Jul;91(1):71-7. doi: 10.1097/00000542-199907000-00013.
Reference Type
BACKGROUND
Verghese ST, McGill WA, Patel RI, Sell JE, Midgley FM, Ruttimann UE. Comparison of three techniques for internal jugular vein cannulation in infants. Paediatr Anaesth. 2000;10(5):505-11. doi: 10.1046/j.1460-9592.2000.00554.x.
Reference Type
BACKGROUND
Grebenik CR, Boyce A, Sinclair ME, Evans RD, Mason DG, Martin B. NICE guidelines for central venous catheterization in children. Is the evidence base sufficient? Br J Anaesth. 2004 Jun;92(6):827-30. doi: 10.1093/bja/aeh134. Epub 2004 Apr 30.
Reference Type
BACKGROUND
Karakitsos D, Labropoulos N, De Groot E, Patrianakos AP, Kouraklis G, Poularas J, Samonis G, Tsoutsos DA, Konstadoulakis MM, Karabinis A. Real-time ultrasound-guided catheterisation of the internal jugular vein: a prospective comparison with the landmark technique in critical care patients. Crit Care. 2006;10(6):R162. doi: 10.1186/cc5101.
Reference Type
BACKGROUND
Turker G, Kaya FN, Gurbet A, Aksu H, Erdogan C, Atlas A. Internal jugular vein cannulation: an ultrasound-guided technique versus a landmark-guided technique. Clinics (Sao Paulo). 2009;64(10):989-92. doi: 10.1590/S1807-59322009001000009.
Reference Type
BACKGROUND
Mitre CI, Golea A, Acalovschi I, Mocan T, Caea AM, Ruta C, Mariana M. Ultrasound-guided external jugular vein cannulation for central venous access by inexperienced trainees. Eur J Anaesthesiol. 2010 Mar;27(3):300-3. doi: 10.1097/EJA.0b013e328333c2d6.
Reference Type
BACKGROUND
Prabhu MV, Juneja D, Gopal PB, Sathyanarayanan M, Subhramanyam S, Gandhe S, Nayak KS. Ultrasound-guided femoral dialysis access placement: a single-center randomized trial. Clin J Am Soc Nephrol. 2010 Feb;5(2):235-9. doi: 10.2215/CJN.04920709. Epub 2009 Dec 3.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Yonei A, Nonoue T, Sari A. Real-time ultrasonic guidance for percutaneous puncture of the internal jugular vein. Anesthesiology. 1986 Jun;64(6):830-1. doi: 10.1097/00000542-198606000-00033. No abstract available.
Reference Type
BACKGROUND
Weiner MM, Geldard P, Mittnacht AJ. Ultrasound-guided vascular access: a comprehensive review. J Cardiothorac Vasc Anesth. 2013 Apr;27(2):345-60. doi: 10.1053/j.jvca.2012.07.007. Epub 2012 Sep 18. No abstract available.
Reference Type
BACKGROUND
Iwashima S, Ishikawa T, Ohzeki T. Ultrasound-guided versus landmark-guided femoral vein access in pediatric cardiac catheterization. Pediatr Cardiol. 2008 Mar;29(2):339-42. doi: 10.1007/s00246-007-9066-2. Epub 2007 Sep 13.
Reference Type
BACKGROUND
Aouad MT, Kanazi GE, Abdallah FW, Moukaddem FH, Turbay MJ, Obeid MY, Siddik-Sayyid SM. Femoral vein cannulation performed by residents: a comparison between ultrasound-guided and landmark technique in infants and children undergoing cardiac surgery. Anesth Analg. 2010 Sep;111(3):724-8. doi: 10.1213/ANE.0b013e3181e9c475. Epub 2010 Jul 2.
Reference Type
BACKGROUND
McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.
Reference Type
BACKGROUND
Mansfield PF, Hohn DC, Fornage BD, Gregurich MA, Ota DM. Complications and failures of subclavian-vein catheterization. N Engl J Med. 1994 Dec 29;331(26):1735-8. doi: 10.1056/NEJM199412293312602.
Reference Type
BACKGROUND
Klerk CP, Smorenburg SM, Buller HR. Thrombosis prophylaxis in patient populations with a central venous catheter: a systematic review. Arch Intern Med. 2003 Sep 8;163(16):1913-21. doi: 10.1001/archinte.163.16.1913.
Reference Type
BACKGROUND
Lamperti M, Bodenham AR, Pittiruti M, Blaivas M, Augoustides JG, Elbarbary M, Pirotte T, Karakitsos D, Ledonne J, Doniger S, Scoppettuolo G, Feller-Kopman D, Schummer W, Biffi R, Desruennes E, Melniker LA, Verghese ST. International evidence-based recommendations on ultrasound-guided vascular access. Intensive Care Med. 2012 Jul;38(7):1105-17. doi: 10.1007/s00134-012-2597-x. Epub 2012 May 22.
Reference Type
BACKGROUND
Other Identifiers
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HRR001
Identifier Type: -
Identifier Source: org_study_id
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