Femoral Central Venous Access Comparison of 2 Methods

Child Clinical Trial

Official title:

Comparison of Effectiveness and Safety of Two Methods for Installing Femoral Central Venous Catheters in Pediatric Intensive Care Units : Anatomical Method vs Ultrasound in Real Time.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02318940
• Other study ID #: HRR001
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2014
• Last updated: May 26, 2015
• Start date: December 2014
• Est. completion date: September 2015

Study information

• Verified date: May 2015
• Source: University of Chile
• Contact: Pietro F Pietroboni, MD
• Phone: +56982261539
• Email: pietroboni[@]gmail.com
• Is FDA regulated: No
• Health authority: Chile: Comité de Ética Científico
• Study type: Interventional

Clinical Trial Summary

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

Description:

STUDY DESIGN Multicenter prospective randomized study in pediatric intensive care units of the Hospital Roberto del Ri , Luis Calvo Mackenna and Exequiel González Cortés. Patients from entering the study between the months of January/2015 to July/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 dicomtómica 9/ c bn .Chi square method

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

• Hemodynamic monitoring

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Child

Intervention

Device:
• central venous catheter
installation of Central venous catheter ultrasound guided
• central venous catheter
installation of Central venous catheter landmark guided

Locations

Country	Name	City	State
Chile	Hospital Exequiel González Cortés	Santiago
Chile	Hospital Luis Calvo Mackenna	Santiago
Chile	Hospital Roberto del Rio	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (23)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. Epub 2004 Apr 30. Review. — View Citation

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. — View Citation

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. Epub 2007 Sep 13. — View Citation

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. — View Citation

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. — View Citation

Karapinar B, Cura A. Complications of central venous catheterization in critically ill children. Pediatr Int. 2007 Oct;49(5):593-9. — View Citation

Klerk CP, Smorenburg SM, Büller HR. Thrombosis prophylaxis in patient populations with a central venous catheter: a systematic review. Arch Intern Med. 2003 Sep 8;163(16):1913-21. Review. — View Citation

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. Review. — View Citation

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. — View Citation

McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Installation on the first try	Is considered successful when installing the CVC is accomplished by first transcutaneous passage to the glass needle	intraoperative	No
Secondary	successful installation	is considered successful installation when the guide is installed without difficulty in femoral vein	intraoperative	No
Secondary	number of attempts	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	intraoperative	No
Secondary	arterial puncture	Arterial puncture aspiration involves pulsatile arterial blood	intraoperative	Yes