Ultrasound Guided Peripheral Intravenous Catheterization in the Pediatric Intensive Care Unit.

Ultrasound Guided Peripheral Intravenous Catheterization in Children Hospitalized in the Pediatric Intensive Care Unit: a Randomized Controlled Prospective Trial.

This is a randomized controlled prospective study. The purpose of this study is to compare a recently described technique of ultrasound (US) guided, dynamic needle tip positioning (DNTP), to the traditional technique of vein visualization and palpation for peripheral venous cannulation in intubated, sedated, and mechanically ventilated pediatric intensive care unit (PICU) patients. First attempt success rate, overall success rate within 3 attempts or 10 minutes (whichever comes first), number of attempts to success, time to success and cannula sizes will be compared between the 2 techniques. The study will include intubated, sedated and mechanically ventilated children, aged 0-18 years, hospitalized in the PICU who require peripheral intravenous (PIV) access for their management.

Study Overview

• Status: Unknown
• Conditions: Peripheral Venous Cannulation
• Intervention / Treatment: Procedure: US guided dynamic needle tip positioning peripheral intravenous cannulation; Procedure: Traditional peripheral intravenous cannulation

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Invasively ventilated
2. Younger than 18 years
3. Peripheral venous access required
4. Difficult intravenous access (DIVA) score of 4 or greater (on a scale of 0-10 with higher scores implying more difficult access)

Exclusion Criteria:

1. Refusal to consent
2. Research staff not available

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ultrasound Guided Dynamic Needle Tip Positioning Technique; In this arm the US transducer, protected with a sterile cover and sterile gel will be placed in the short axis above the distal end of the selected vein, moving the probe to place the vein in the center of the ultrasound screen under the middle mark of the image. The catheter needle will be inserted close to the transducer. The needle tip will be visualized as a white dot on the ultrasound screen. Then, the transducer will be shifted slightly proximally until the white dot disappears from the screen. The needle and the transducer will be moved alternately toward the patient several times to visualize the needle tip in real time. After penetrating the anterior wall of the vein, these steps will be repeated a few more times with a smaller insertion angle to visualize the white dot in the vein. Finally, the outer catheter will be fully advanced and the needle core will be extracted.	Procedure: US guided dynamic needle tip positioning peripheral intravenous cannulation; Catheterizations will be performed by one of three pediatric intensivists with vast experience in both traditional and US guided DNTP techniques for peripheral intravenous access. The operator will be allowed to independently choose which peripheral vein to cannulate. If necessary, patients will be given supplemental dose of sedation and analgesia in addition to the already given continuous infusions for invasive mechanical ventilation. Before puncture, the limb will be taped and maintained in an optimal position. A tourniquet will be placed proximal to the planned cannulation site. The site of puncture will be disinfected with Chlorhexidine gluconate 0.5% w/v, Alcohol 70% v/v. The choice of catheter will be left to the discretion of the operator. Available PIV cannulas include : 14 GA, 2X45 mm; 17 GA, 1.4X45 mm; 18 GA 1.2X45 mm; 20 GA 1X32mm BD Venflon™ and 24 GA, 0.7X19 mm; 26 GA 0.6X19 mm BD Neoflon™ (Becton Dickinson Infusion Therapy AB, Helsingborg, Sweden).
ACTIVE_COMPARATOR: Traditional insertion group; For traditional insertion technique insertion attempt will be blind or tactile. Otherwise, the same protocol and measurements as elaborated for the US guided group will be applied.	Procedure: Traditional peripheral intravenous cannulation; For traditional insertion technique insertion attempt will be blind or tactile.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of peripheral IV cannulation on first attempt	Assessment of peripheral IV cannulation success on first attempt (Yes vs No)	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall peripheral IV cannulation success rate	The overall success rate of peripheral intravenous cannulation within 3 attempts.	10 minutes
Time to successful peripheral IV cannulation	Defined as the time from first skin puncture to successful cannulation (minutes).	up to 10 minutes
Number of attempts to success	Number of puncture attempts (1,2 or 3) needed for achieving a a successful cannulation	up to 10 minutes
Inserted cannula diameter	Cannula diameter (in GA) successfully inserted	up to 10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient age	Age in years	1 day (At the time of peripheral IV cannulation)
Patient sex	Female vs Male	1 day (At the time of peripheral IV cannulation)
Patient body mass index (BMI)	BMI (in kg/m^2) for age percentile	1 day (At the time of peripheral IV cannulation)
Patient inotropic and vasoactive support	Vasoactive-Inotropic Score (VIS score)	1 day (At the time of peripheral IV cannulation)
Admission-cannulation time	Time from hospital admission to first attempt of cannulation	1 day (At the time of peripheral IV cannulation)
Reason for admission	Medical vs Surgical	1 day (At the time of peripheral IV cannulation)

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Avichai Weissbach, MD, Rabin Medical Center

Publications and helpful links

General Publications

• Kiberenge RK, Ueda K, Rosauer B. Ultrasound-Guided Dynamic Needle Tip Positioning Technique Versus Palpation Technique for Radial Arterial Cannulation in Adult Surgical Patients: A Randomized Controlled Trial. Anesth Analg. 2018 Jan;126(1):120-126. doi: 10.1213/ANE.0000000000002261.
• Liu L, Tan Y, Li S, Tian J. "Modified Dynamic Needle Tip Positioning" Short-Axis, Out-of-Plane, Ultrasound-Guided Radial Artery Cannulation in Neonates: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):178-183. doi: 10.1213/ANE.0000000000003445.
• Takeshita J, Yoshida T, Nakajima Y, Nakayama Y, Nishiyama K, Ito Y, Shimizu Y, Takeuchi M, Shime N. Dynamic Needle Tip Positioning for Ultrasound-Guided Arterial Catheterization in Infants and Small Children With Deep Arteries: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1919-1925. doi: 10.1053/j.jvca.2018.12.002. Epub 2018 Dec 4.
• Costantino TG, Parikh AK, Satz WA, Fojtik JP. Ultrasonography-guided peripheral intravenous access versus traditional approaches in patients with difficult intravenous access. Ann Emerg Med. 2005 Nov;46(5):456-61. doi: 10.1016/j.annemergmed.2004.12.026.
• Doniger SJ, Ishimine P, Fox JC, Kanegaye JT. Randomized controlled trial of ultrasound-guided peripheral intravenous catheter placement versus traditional techniques in difficult-access pediatric patients. Pediatr Emerg Care. 2009 Mar;25(3):154-9. doi: 10.1097/PEC.0b013e31819a8946.
• Otani T, Morikawa Y, Hayakawa I, Atsumi Y, Tomari K, Tomobe Y, Uda K, Funakoshi Y, Sakaguchi C, Nishimoto S, Hataya H. Ultrasound-guided peripheral intravenous access placement for children in the emergency department. Eur J Pediatr. 2018 Oct;177(10):1443-1449. doi: 10.1007/s00431-018-3201-3. Epub 2018 Jun 30.
• Vinograd AM, Zorc JJ, Dean AJ, Abbadessa MKF, Chen AE. First-Attempt Success, Longevity, and Complication Rates of Ultrasound-Guided Peripheral Intravenous Catheters in Children. Pediatr Emerg Care. 2018 Jun;34(6):376-380. doi: 10.1097/PEC.0000000000001063.
• Elkhunovich M, Barreras J, Bock Pinero V, Ziv N, Vaiyani A, Mailhot T. The use of ultrasound for peripheral IV placement by vascular access team nurses at a tertiary children's hospital. J Vasc Access. 2017 Jan 18;18(1):57-63. doi: 10.5301/jva.5000615. Epub 2016 Nov 15.
• Benkhadra M, Collignon M, Fournel I, Oeuvrard C, Rollin P, Perrin M, Volot F, Girard C. Ultrasound guidance allows faster peripheral IV cannulation in children under 3 years of age with difficult venous access: a prospective randomized study. Paediatr Anaesth. 2012 May;22(5):449-54. doi: 10.1111/j.1460-9592.2012.03830.x. Epub 2012 Mar 12.
• Takeshita J, Inata Y, Ito Y, Nishiyama K, Shimizu Y, Takeuchi M, Shime N. Dynamic Needle Tip Positioning for Ultrasound-Guided Placement of a Peripherally Inserted Central Catheter in Pediatric Patients. J Cardiothorac Vasc Anesth. 2020 Jan;34(1):114-118. doi: 10.1053/j.jvca.2019.04.029. Epub 2019 May 2.
• Takeshita J, Yoshida T, Nakajima Y, Nakayama Y, Nishiyama K, Ito Y, Shimizu Y, Takeuchi M, Shime N. Superiority of Dynamic Needle Tip Positioning for Ultrasound-Guided Peripheral Venous Catheterization in Patients Younger Than 2 Years Old: A Randomized Controlled Trial. Pediatr Crit Care Med. 2019 Sep;20(9):e410-e414. doi: 10.1097/PCC.0000000000002034.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: February 9, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (ACTUAL): February 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 0044-20-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No