Trial Outcomes & Findings for Efficacy of Near-Infrared Vein Imaging for Difficult IV Placement (NCT NCT04262947)

Results Overview

Rate of successful initial placement of a peripheral venous catheter (investigators have up to 30 minutes or ONE attempt before the study allows for change of technique to the preference of the Vascular Access Team member)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

up to 30 minutes

Results posted on

2022-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Conventional Method Placement of peripheral venous catheter using conventional methods Conventional IV placement: IV placement utilizing conventional methods	VeinViewer Visualization Only Use of a VeinViewer to visualize the most suitable target. Once the target has been identified and marked, the device will be placed aside and the peripheral venous catheter will be placed using conventional methods Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement Conventional IV placement: IV placement utilizing conventional methods	Constant Imaging With VeinViewer Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement
Overall Study STARTED	13	13	12
Overall Study COMPLETED	13	13	12
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

38 patients is total number of study population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Method n=13 Participants Placement of peripheral venous catheter using conventional methods Conventional IV placement: IV placement utilizing conventional methods	VeinViewer Visualization Only n=13 Participants Use of a VeinViewer to visualize the most suitable target. Once the target has been identified and marked, the device will be placed aside and the peripheral venous catheter will be placed using conventional methods Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement Conventional IV placement: IV placement utilizing conventional methods	Constant Imaging With VeinViewer n=12 Participants Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants • 38 patients is total number of study population	0 Participants n=13 Participants • 38 patients is total number of study population	0 Participants n=12 Participants • 38 patients is total number of study population	0 Participants n=38 Participants • 38 patients is total number of study population
Age, Categorical Between 18 and 65 years	10 Participants n=13 Participants • 38 patients is total number of study population	9 Participants n=13 Participants • 38 patients is total number of study population	8 Participants n=12 Participants • 38 patients is total number of study population	27 Participants n=38 Participants • 38 patients is total number of study population
Age, Categorical >=65 years	3 Participants n=13 Participants • 38 patients is total number of study population	4 Participants n=13 Participants • 38 patients is total number of study population	4 Participants n=12 Participants • 38 patients is total number of study population	11 Participants n=38 Participants • 38 patients is total number of study population
Sex: Female, Male Female	9 Participants n=13 Participants	7 Participants n=13 Participants	7 Participants n=12 Participants	23 Participants n=38 Participants
Sex: Female, Male Male	4 Participants n=13 Participants	6 Participants n=13 Participants	5 Participants n=12 Participants	15 Participants n=38 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: up to 30 minutes

Rate of successful initial placement of a peripheral venous catheter (investigators have up to 30 minutes or ONE attempt before the study allows for change of technique to the preference of the Vascular Access Team member)

Outcome measures

Outcome measures
Measure	Conventional Method n=13 Participants Placement of peripheral venous catheter using conventional methods Conventional IV placement: IV placement utilizing conventional methods	VeinViewer Visualization Only n=13 Participants Use of a VeinViewer to visualize the most suitable target. Once the target has been identified and marked, the device will be placed aside and the peripheral venous catheter will be placed using conventional methods Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement Conventional IV placement: IV placement utilizing conventional methods	Constant Imaging With VeinViewer n=12 Participants Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer Near Infrared Vein Imaging: Use of NI vein imaging device for visualization of veins during peripheral IV placement
Number of Participants With Successful Initial IV Placement	10 Participants	6 Participants	6 Participants

Adverse Events

Conventional Method

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

VeinViewer Visualization Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Constant Imaging With VeinViewer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Schnelldorfer

Lahey Hospital and Medical Center

Phone: 781-744-5100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place