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

Not Applicable

• Conditions: Peripheral Venous Cannulation
• Interventions: Procedure: US guided dynamic needle tip positioning peripheral intravenous cannulation; Procedure: Traditional peripheral intravenous cannulation

• Registration Number: NCT04268225
• Lead Sponsor: Rabin Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-13
• Study Start: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-13
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Guided Dynamic Needle Tip Positioning Technique	US guided dynamic needle tip positioning peripheral intravenous cannulation	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.
Traditional insertion group	Traditional peripheral intravenous cannulation	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.

Primary Outcome Measures

Name	Time	Method
Success of peripheral IV cannulation on first attempt	10 minutes	Assessment of peripheral IV cannulation success on first attempt (Yes vs No)

Secondary Outcome Measures

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