POCUS for Difficult Peripheral Access in the Emergency Department - a RCT
NCT ID: NCT05119673
Last Updated: 2023-05-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
442 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-10-22
Study Completion Date
2022-05-11
Brief Summary
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Peripheral intravenous line insertion is the most commonly performed invasive procedure in the emergency department (ED). The research hypothesis is that a biplane sonographic approach (i.e., an out-of-plane and in-plane view) might be superior to a mono-plane approach (i.e., an out-of-plane or in-plane view) obtaining a peripheral vascular access among difficult patients admitted to the ED
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Detailed Description
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Peripheral intravenous line insertion is the most commonly performed invasive procedure in the emergency department (ED). In some studies, difficult vascular access population was about 33% of evaluated patients and for most of them the "blind" method (i.e., palpation) fails in the line insertion. Ultrasound guidance often increase the success rate among these patients.
Two basic techniques were proposed for sonographic guidance, a transversal or a longitudinal approach to the chosen vessel (i.e., out-of-plane or in-plane view, respectively, "mono-plane" approach).
The availability of hand-held sonographic devices is increasing the number of emergency department were this guidance is used in a difficult vascular access population.
The Butterly iQ+ device is now able to show out-of-plane and in-plane views, simultaneously, the so called bi-plane view.
Aim of this randomized controlled trial is to test if a bi-plane sonographic vision might be able to increase the performance of trained operators in obtaining a peripheral vascular access among difficult patients admitted to the ED.
The present study will be a randomized controlled, 2-arm, nonblinded trial held at the Città della Salute e della Scienza di Torino, University hospital, Turin, Italy.
All healthcare workers already trained in ultrasound-guided vascular access will be considered eligible for the study (i.e., emergency physicians, residents, nurses) after an ad hoc brief (2 hours) training on the study.
This will be a "real world" study, each provider will be free of choosing the device he/she thought appropriate for each patient (in terms of length, gauge, type - peripheral midline will be included in the Italian center).
Using a computerized permuted blocks of random sizes, enrolled patients will be randomized in a 1:1 ratio to be evaluated using either the "standard" ultrasound-guided approach (out-of-place or in-plane view) or the bi-plane view (i.e. out-of-place and in-plane view, simultaneously).
Two basic techniques were proposed for sonographic guidance, a transversal or a longitudinal approach to the chosen vessel (i.e., out-of-plane or in-plane view, respectively, "mono-plane" approach).
The availability of hand-held sonographic devices is increasing the number of emergency department were this guidance is used in a difficult vascular access population.
The Butterly iQ+ device is now able to show out-of-plane and in-plane views, simultaneously, the so called bi-plane view.
Aim of this randomized controlled trial is to test if a bi-plane sonographic vision might be able to increase the performance of trained operators in obtaining a peripheral vascular access among difficult patients admitted to the ED.
The present study will be a randomized controlled, 2-arm, nonblinded trial held at the Città della Salute e della Scienza di Torino, University hospital, Turin, Italy.
All healthcare workers already trained in ultrasound-guided vascular access will be considered eligible for the study (i.e., emergency physicians, residents, nurses) after an ad hoc brief (2 hours) training on the study.
This will be a "real world" study, each provider will be free of choosing the device he/she thought appropriate for each patient (in terms of length, gauge, type - peripheral midline will be included in the Italian center).
Using a computerized permuted blocks of random sizes, enrolled patients will be randomized in a 1:1 ratio to be evaluated using either the "standard" ultrasound-guided approach (out-of-place or in-plane view) or the bi-plane view (i.e. out-of-place and in-plane view, simultaneously).
Conditions
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Vascular Access
Emergencies
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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mono-plane sonographic view
Usual standard of care, in our institution, for difficult peripheral vascular access in the Emergency Department.
Group Type
NO_INTERVENTION
No interventions assigned to this group
bi-plane sonographic view
Group Type
ACTIVE_COMPARATOR
bi-plane sonographic view to difficult peripheral vascular access using Butterfly iQ+®
Intervention Type
OTHER
Bi-plane Butterfly iQ+® sonographic visualization will be used to help Emergency Department operators to get a venous peripheral access in a population of patients considered difficult for this task based on their history or the present clinical situation.
Interventions
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bi-plane sonographic view to difficult peripheral vascular access using Butterfly iQ+®
Bi-plane Butterfly iQ+® sonographic visualization will be used to help Emergency Department operators to get a venous peripheral access in a population of patients considered difficult for this task based on their history or the present clinical situation.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* chronic renal disease/ongoing dialysis;
* sickle cell anemia;
* prolonged and/or frequent use of i.v. drugs;
* difficult vascular access (after a first attempt or self-reported);
* previously need for more than one attempts / ultrasound guidance for getting a peripheral vascular access.
* sickle cell anemia;
* prolonged and/or frequent use of i.v. drugs;
* difficult vascular access (after a first attempt or self-reported);
* previously need for more than one attempts / ultrasound guidance for getting a peripheral vascular access.
Exclusion Criteria
* no consent to participate in the study.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Butterfly Network
INDUSTRY
Sponsor Role
collaborator
University of Turin, Italy
OTHER
Sponsor Role
lead
Responsible Party
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Emanuele Pivetta
Staff physician
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Emanuele Pivetta, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Città della Salute e della Scienza di Torino University Hospital
Locations
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Emergency Department, Città della Salute e della Scienza di Torino Univeristy Hospital
Turin, , Italy
Site Status
Countries
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Italy
References
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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.
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Oliver WC Jr, Nuttall GA, Beynen FM, Raimundo HS, Abenstein JP, Arnold JJ. The incidence of artery puncture with central venous cannulation using a modified technique for detection and prevention of arterial cannulation. J Cardiothorac Vasc Anesth. 1997 Dec;11(7):851-5. doi: 10.1016/s1053-0770(97)90119-1.
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Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996 Dec;24(12):2053-8. doi: 10.1097/00003246-199612000-00020.
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Schummer W, Schummer C, Tuppatsch H, Fuchs J, Bloos F, Huttemann E. Ultrasound-guided central venous cannulation: is there a difference between Doppler and B-mode ultrasound? J Clin Anesth. 2006 May;18(3):167-72. doi: 10.1016/j.jclinane.2005.12.010.
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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.
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Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.
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Keenan SP. Use of ultrasound to place central lines. J Crit Care. 2002 Jun;17(2):126-37. doi: 10.1053/jcrc.2002.34364.
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RESULT
Leung J, Duffy M, Finckh A. Real-time ultrasonographically-guided internal jugular vein catheterization in the emergency department increases success rates and reduces complications: a randomized, prospective study. Ann Emerg Med. 2006 Nov;48(5):540-7. doi: 10.1016/j.annemergmed.2006.01.011. Epub 2006 Feb 21.
Reference Type
RESULT
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.
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Augoustides JG, Horak J, Ochroch AE, Vernick WJ, Gambone AJ, Weiner J, Pinchasik D, Kowalchuk D, Savino JS, Jobes DR. A randomized controlled clinical trial of real-time needle-guided ultrasound for internal jugular venous cannulation in a large university anesthesia department. J Cardiothorac Vasc Anesth. 2005 Jun;19(3):310-5. doi: 10.1053/j.jvca.2005.03.007.
Reference Type
RESULT
Troianos CA, Jobes DR, Ellison N. Ultrasound-guided cannulation of the internal jugular vein. A prospective, randomized study. Anesth Analg. 1991 Jun;72(6):823-6. doi: 10.1213/00000539-199106000-00020. No abstract available.
Reference Type
RESULT
Mallory DL, McGee WT, Shawker TH, Brenner M, Bailey KR, Evans RG, Parker MM, Farmer JC, Parillo JE. Ultrasound guidance improves the success rate of internal jugular vein cannulation. A prospective, randomized trial. Chest. 1990 Jul;98(1):157-60. doi: 10.1378/chest.98.1.157.
Reference Type
RESULT
Pittiruti M, Hamilton H, Biffi R, MacFie J, Pertkiewicz M; ESPEN. ESPEN Guidelines on Parenteral Nutrition: central venous catheters (access, care, diagnosis and therapy of complications). Clin Nutr. 2009 Aug;28(4):365-77. doi: 10.1016/j.clnu.2009.03.015. Epub 2009 May 21.
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RESULT
Troianos CA, Hartman GS, Glas KE, Skubas NJ, Eberhardt RT, Walker JD, Reeves ST; Councils on Intraoperative Echocardiography and Vascular Ultrasound of the American Society of Echocardiography. Guidelines for performing ultrasound guided vascular cannulation: recommendations of the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2011 Dec;24(12):1291-318. doi: 10.1016/j.echo.2011.09.021. No abstract available.
Reference Type
RESULT
Maecken T, Grau T. Ultrasound imaging in vascular access. Crit Care Med. 2007 May;35(5 Suppl):S178-85. doi: 10.1097/01.CCM.0000260629.86351.A5.
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RESULT
Kumar A, Chuan A. Ultrasound guided vascular access: efficacy and safety. Best Pract Res Clin Anaesthesiol. 2009 Sep;23(3):299-311. doi: 10.1016/j.bpa.2009.02.006.
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RESULT
Chapman GA, Johnson D, Bodenham AR. Visualisation of needle position using ultrasonography. Anaesthesia. 2006 Feb;61(2):148-58. doi: 10.1111/j.1365-2044.2005.04475.x.
Reference Type
RESULT
Ortega R, Song M, Hansen CJ, Barash P. Videos in clinical medicine. Ultrasound-guided internal jugular vein cannulation. N Engl J Med. 2010 Apr 22;362(16):e57. doi: 10.1056/NEJMvcm0810156. No abstract available.
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RESULT
French JL, Raine-Fenning NJ, Hardman JG, Bedforth NM. Pitfalls of ultrasound guided vascular access: the use of three/four-dimensional ultrasound. Anaesthesia. 2008 Aug;63(8):806-13. doi: 10.1111/j.1365-2044.2008.05513.x. Epub 2008 Jun 28.
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RESULT
Hopkins RE, Bradley M. In-vitro visualization of biopsy needles with ultrasound: a comparative study of standard and echogenic needles using an ultrasound phantom. Clin Radiol. 2001 Jun;56(6):499-502. doi: 10.1053/crad.2000.0707.
Reference Type
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Venkatesan K. Echo-enhanced needles for short-axis ultrasound-guided vascular access. Int J Emerg Med. 2010 Apr 10;3(3):205. doi: 10.1007/s12245-010-0164-1. No abstract available.
Reference Type
RESULT
Reynolds N, McCulloch AS, Pennington CR, MacFadyen RJ. Assessment of distal tip position of long-term central venous feeding catheters using transesophageal echocardiology. JPEN J Parenter Enteral Nutr. 2001 Jan-Feb;25(1):39-41. doi: 10.1177/014860710102500139.
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RESULT
Hsu JH, Wang CK, Chu KS, Cheng KI, Chuang HY, Jaw TS, Wu JR. Comparison of radiographic landmarks and the echocardiographic SVC/RA junction in the positioning of long-term central venous catheters. Acta Anaesthesiol Scand. 2006 Jul;50(6):731-5. doi: 10.1111/j.1399-6576.2006.01025.x.
Reference Type
RESULT
Leyvi G, Taylor DG, Reith E, Wasnick JD. Utility of ultrasound-guided central venous cannulation in pediatric surgical patients: a clinical series. Paediatr Anaesth. 2005 Nov;15(11):953-8. doi: 10.1111/j.1460-9592.2005.01609.x.
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RESULT
Lamperti M, Caldiroli D, Cortellazzi P, Vailati D, Pedicelli A, Tosi F, Piastra M, Pietrini D. Safety and efficacy of ultrasound assistance during internal jugular vein cannulation in neurosurgical infants. Intensive Care Med. 2008 Nov;34(11):2100-5. doi: 10.1007/s00134-008-1210-9. Epub 2008 Jul 11.
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RESULT
Abboud PA, Kendall JL. Ultrasound guidance for vascular access. Emerg Med Clin North Am. 2004 Aug;22(3):749-73. doi: 10.1016/j.emc.2004.04.003.
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RESULT
Stone MB, Moon C, Sutijono D, Blaivas M. Needle tip visualization during ultrasound-guided vascular access: short-axis vs long-axis approach. Am J Emerg Med. 2010 Mar;28(3):343-7. doi: 10.1016/j.ajem.2008.11.022. Epub 2010 Jan 28.
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RESULT
Nichols I, Humphrey JP. The efficacy of upper arm placement of peripherally inserted central catheters using bedside ultrasound and microintroducer technique. J Infus Nurs. 2008 May-Jun;31(3):165-76. doi: 10.1097/01.NAN.0000317703.66395.b8.
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RESULT
Calvert N, Hind D, McWilliams R, Davidson A, Beverley CA, Thomas SM. Ultrasound for central venous cannulation: economic evaluation of cost-effectiveness. Anaesthesia. 2004 Nov;59(11):1116-20. doi: 10.1111/j.1365-2044.2004.03906.x.
Reference Type
RESULT
Convissar D, Bittner EA, Chang MG. Biplane Imaging Versus Standard Transverse Single-Plane Imaging for Ultrasound-Guided Peripheral Intravenous Access: A Prospective Controlled Crossover Trial. Crit Care Explor. 2021 Oct 8;3(10):e545. doi: 10.1097/CCE.0000000000000545. eCollection 2021 Oct.
Reference Type
RESULT
Other Identifiers
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POCUS-DiffAcc
Identifier Type: -
Identifier Source: org_study_id
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