Trial Outcomes & Findings for Ultrasound-guided Peripheral IJ Study (NCT NCT03231345)

Results Overview

The primary study endpoint is successful cannulation vs failure to cannulate the internal jugular vein.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Less than 20 minutes

Results posted on

2019-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	US Guided IJ A physician placed ultrasound-guided IV in the internal jugular vein US guided IJ: IV catheter placement Ultrasound: Ultrasound-guided Internal Jugular vein
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound-guided Peripheral IJ Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	US Guided IJ n=35 Participants A physician placed ultrasound-guided IV in the internal jugular vein US guided IJ: IV catheter placement Ultrasound: Ultrasound-guided Internal Jugular vein
Age, Continuous	48.2 years STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	14 Participants n=5 Participants
Race/Ethnicity, Customized African American	14 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Region of Enrollment United States	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: Less than 20 minutes

The primary study endpoint is successful cannulation vs failure to cannulate the internal jugular vein.

Outcome measures

Outcome measures
Measure	US Guided IJ n=35 Participants A physician placed ultrasound-guided IV in the internal jugular vein US guided IJ: IV catheter placement Ultrasound: Ultrasound-guided Internal Jugular vein
Number of Participants With Successful Cannulation of the Internal Jugular Vein	34 Participants

SECONDARY outcome

Timeframe: 24 hours

Percentage of Participants with successfully placed lines with a complication

Outcome measures

Outcome measures
Measure	US Guided IJ n=34 Participants A physician placed ultrasound-guided IV in the internal jugular vein US guided IJ: IV catheter placement Ultrasound: Ultrasound-guided Internal Jugular vein
Prevalence of Complications Related to Cannulation of the Internal Jugular Vein.	1 Participants

SECONDARY outcome

Timeframe: Less than 20 minutes

The median time it took an Emergency Physician from needle puncture to cannulation in minutes

Outcome measures

Outcome measures
Measure	US Guided IJ n=34 Participants A physician placed ultrasound-guided IV in the internal jugular vein US guided IJ: IV catheter placement Ultrasound: Ultrasound-guided Internal Jugular vein
The Median Time Required for Cannulation of the Internal Jugular Vein by an Emergency Physician.	3.1 minutes Interval 0.98 to 4.2

Adverse Events

US Guided IJ

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	US Guided IJ n=35 participants at risk A physician placed ultrasound-guided IV in the internal jugular vein US guided IJ: IV catheter placement Ultrasound: Ultrasound-guided Internal Jugular vein
Vascular disorders Complications from IV line placement	2.9% 1/35 • Number of events 1 • We monitored for adverse events throughout the patient's hospitalization, the length of which ranged from a few hours to a maximum of 2 weeks. The adverse events that we tracked included local hematoma, pneumothorax, arterial puncture, bacteremia/line infection, and line thrombus. Trained research assistants watched line placement to assess for these complications. They also rechecked the line 1 hour after placement, and then once every 24 hours until the line was removed. They also checked the results of CXRs to look for pneumothoraces, and they checked blood cultures results.

Additional Information

Dr. Zitek

University Medical Center of Southern Nevada

Phone: 702-383-7885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place