Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
INSTALLATION METHOD
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Landmark method | Other | 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 |
|
| Ultrasound method | Active Comparator | installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| central venous catheter | Device | installation of Central venous catheter ultrasound guided |
|
| Measure | Description | Time Frame |
|---|---|---|
| Installation on the First Try | Percentage of Participants with successful installation on the first transcutaneous passage of the glass needle | intraoperative, an average of 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Installation | Percentage of participants with successful installation of guide without difficulty in the femoral vein | intraoperative, an average of 1 hour |
| Number of Attempts | Number of participants who succeeded in the installation of cvc in one, two, three, four or five attempts. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pietro F Pietroboni, MD | University of Chile | Principal Investigator |
| Cristian Carvajal, MD, Mg | Hospital Roberto del RÃo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Exequiel González Cortés | Santiago | Santiago Metropolitan | 8320000 | Chile | ||
| Hospital Roberto del Rio |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23249991 | Background | 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. | |
| 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 | ||
| 22307320 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 central venous catheter: installation of Central venous catheter landmark guided |
| FG001 | 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 central venous catheter: installation of Central venous catheter ultrasound guided |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 central venous catheter: installation of Central venous catheter landmark guided |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Installation on the First Try | Percentage of Participants with successful installation on the first transcutaneous passage of the glass needle | Posted | Number | percentage of participants | intraoperative, an average of 1 hour |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 central venous catheter: installation of Central venous catheter landmark guided |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pietro Pietroboni Fuster | Universidad de Chile | +56982261539 | pietroboni@gmail.com |
Not provided
| ID | Term |
|---|---|
| D062905 | Central Venous Catheters |
| ID | Term |
|---|---|
| D062666 | Vascular Access Devices |
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| central venous catheter | Device | installation of Central venous catheter landmark guided |
|
| intraoperative, an average of 1 hour |
| Arterial Puncture | Percentage of participants with Arterial puncture aspiration | intraoperative, an average of 1 hour |
| Santiago |
| Santiago Metropolitan |
| 8320000 |
| Chile |
| 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. |
| 9823406 | 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. |
| 17875082 | 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. |
| 12797890 | 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. |
| 9055771 | 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. |
| 10422930 | 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. |
| 11012954 | 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. |
| 15121722 | 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. |
| 17112371 | 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. |
| 19841706 | 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. |
| 19935072 | 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. |
| 19965532 | 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. |
| 21494105 | 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. |
| 3717653 | 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. |
| 22995457 | 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. |
| 17851631 | 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. |
| 20601450 | 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. |
| 12646670 | 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. |
| 7984193 | 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. |
| 12963564 | 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. |
| 22614241 | 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. |
| 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 central venous catheter: installation of Central venous catheter ultrasound guided |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| weight | Median | Full Range | kg |
|
|
|
| Secondary | Successful Installation | Percentage of participants with successful installation of guide without difficulty in the femoral vein | Posted | Number | percentage of participants | intraoperative, an average of 1 hour |
|
|
|
| Secondary | Number of Attempts | Number of participants who succeeded in the installation of cvc in one, two, three, four or five attempts. | Posted | Number | participants | intraoperative, an average of 1 hour |
|
|
|
| Secondary | Arterial Puncture | Percentage of participants with Arterial puncture aspiration | Posted | Number | percentage of participants | intraoperative, an average of 1 hour |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 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 central venous catheter: installation of Central venous catheter ultrasound guided | 0 | 50 | 0 | 50 |
Not provided
Not provided
| third attempt |
|
| fourth attempt |
|
| fifth attempt |
|
| Unsuccessful cannulation |
|