The Efficacy of Near-Infrared Vein Imaging for the Success of Placing Peripheral Venous Catheters in Adults With Difficult Venous Access
Phase: NA
Conditions: Catheterization, Peripheral
Sponsor: Lahey Clinic

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Research Protocol LCID # 20193166                NCT#: NCT04262947 
 
Sponsor: Lahey Hospital & Medical Center 
 
 
 
The Efficacy of Near-infrared Vein Imaging  
for the Success of Placing  
Peripheral Venous Catheters  
in Adults with Difficult Venous Access 
 
 
 
Thomas Schnelldorfer, MD, PhD 
Principle Investigator 
Associate Professor of Surgery and Biomedical Engineering 
Division of General Surgery, Lahey Hospital & Medical Center 
41 Mall Road, Burlington, MA 01805 
(781) 744-8580, thomas.schnelldorfer@lahey.org 
 
Hannah Gurley (Coordinator) 
Tufts Post-Baccalaureate Student 
Division of General Surgery, Lahey Hospital & Medical Center 
 
Victoria M Errico, BSN, RN, VABC (Co-Investigator) 
Staff RN, Vascular Access Team 
Department of Nursing; Lahey Hospital & Medical Center 
 
Lisa M Price, BSN, RN, VABC (Co-Investigator) 
Staff RN, Vascular Access Team 
Department of Nursing; Lahey Hospital & Medical Center 
 
Janet J Schwartz, BSN, RN, VABC (Co-Investigator) 
Staff RN, Vascular Access Team 
Department of Nursing; Lahey Hospital & Medical Center 
 
Rajni Sahore, BSN, RN, VABC (Co-Investigator) 
Staff RN, Vascular Access Team 
Department of Nursing; Lahey Hospital & Medical Center 
 
Karina Cote, BSN, RN (Coordinator) 
Nurse Manager, Vascular Access Team 
Department of Nursing; Lahey Hospital & Medical Center 
 
Robin Ruthazer, MPH (Collaborator) 
Associate Director, Biostatistics, Epidemiology, and Research Design (BERD) Center 
Clinical and Translational Science Institute, Tufts University 

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Table of Contents 
 
Background and Study Rationale .................................................................................... 3 
IV Access for In-hospital Patients ................................................................................ 3 
Near-infrared Superficial Vein Imaging ........................................................................ 3 
Study Objectives ............................................................................................................. 5 
Primary Objective ........................................................................................................ 5 
Secondary Objectives .................................................................................................. 5 
Study Design ................................................................................................................... 6 
Study Overview............................................................................................................ 6 
Eligibility Criteria .......................................................................................................... 6 
Recruitment ................................................................................................................. 7 
Informed Consent Process .......................................................................................... 7 
Study Procedures ............................................................................................................ 8 
Imaging System To Be Utilized .................................................................................... 8 
Training of Staff ........................................................................................................... 9 
Peripheral Venous Cannulation and Randomization of Study Groups ........................ 9 
Follow-Up (for in-patients only) .................................................................................. 10 
Data Collection .......................................................................................................... 10 
Study Endpoints ............................................................................................................ 12 
Study Endpoints ........................................................................................................ 12 
Sample Size and Power Determination ..................................................................... 12 
Data Analysis and Statistical Methods ....................................................................... 12 
Study Monitoring and Safety Plan ................................................................................. 13 
Study Monitoring ........................................................................................................ 13 
Protection of Human Subjects ................................................................................... 13 
Risks .......................................................................................................................... 13 
Benefits and Alternatives ........................................................................................... 14 
Importance of the Knowledge To Be Gained ............................................................. 14 
Limitations ................................................................................................................. 15 
Study Resources and Finances .................................................................................... 16 
Institutional Resources .............................................................................................. 16 
Financial Resources .................................................................................................. 16 
Conflict of Interest ...................................................................................................... 16 
References .................................................................................................................... 17 
 
 
 

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Background and Study Rationale 
 
IV Access for In-hospital Patients 
In-hospital patients are commonly subjected to repeated intravenous infusions and 
medication administrations.  The repeated placement of intravenous catheters is 
thought to compromise the integrity of superficial veins.  Hence, finding a suitable 
peripheral vein continues to be a recurring challenge for healthcare providers.  In 
addition, complications associated with venous access placement are a common 
burden, including hematomas, phlebitis, thrombophlebitis, infiltration, and nerve 
damage.  Therefore a tremendous need for easier and more reliable intravenous access 
is present. 
 
Near-infrared Superficial Vein Imaging 
Recently, vein imaging devices became available in the form of portable devices 
utilizing near-infrared (NIR) light at a wavelength of approximately 850 nm to create a 
real-time map of superficial veins.  With these devices, NIR light is projected onto the 
surface of the patient’s skin where it can penetrate depending on the device’s light 
intensity typically up to 10 mm deep into the tissue [1].  Once NIR propagates through 
the tissue it encounters some degree of absorption dependent on the characteristics of 
the tissue molecules.  With hemoglobin having a much greater absorption coefficient 
compared to most other tissue molecules [2], the reflected light signal provides a 
negative contrast image of blood vessels.  While the depth of visualization of blood 
vessels is dependent on specific tissue conditions, larger vessels underneath the skin 
typically used for peripheral venous access are expected to be visualized reliably using 
this technology. 
 
 
Figure 1: VeinViewer Flex (Christie Medical Holdings, Inc., Memphis, TN) 
 
With the expected improvement of visualizing superficial veins, the manufactures of 
these devices proposed anticipated clinical benefits to include increased identification of 
suitable venous access sites, better choice of catheter gauge, and better identification 
of potential problem locations within veins such as valves and bifurcations.  In select 
circumstances, flushing of the placed IV catheter under NIR visualization may also 

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provide improved information about the patency of the vein.  Overall, improvement in 
peripheral venous access using this technology may theoretically avoid more invasive 
venous access catheters, such as peripherally inserted central catheters or central 
venous catheters. 
 
In the clinical setting, NIR technology has shown to significantly increase the number of 
identifiable possible cannulation sites compared with normal eyesight [3,4].  However, 
the improvement in visualization did not automatically translate into improvement in 
successful cannulation of veins.  Specifically, the efficacy of these vein finding devices 
has shown limited benefit when tested in the pediatric in-hospital population with a 
nonselective use in all patients.  A meta-analysis of 11 RCTs concluded that using NIR 
light devices did not have an impact on overall failure rate at the first attempt at 
peripheral intravenous cannulation (PIVC) in pediatric patients [5].  Similarly, in studies 
evaluating the number of attempts required for successful PIVC found no difference 
between the NIR light device and traditional methods [6].  Many investigators 
subjectively felt the NIR device to be helpful; particularly in selected patients [5].  Yet, 
subgroup analysis did not define the cohort of pediatric patients that would benefit most 
from this technology.  One publication interpreted these outcomes as such that despite 
improved visualization of superficial veins, successful venous puncture remains heavily 
dependent on the skills of the operator [7]. 
 
The efficacy of NIR vein finders beyond the first line approach, particularly in patients 
that have failed conventional peripheral venous access methods or in patients that are 
expected to be a “difficult stick”, is not established.  Conflicting results have been 
reported in the pediatric literature regarding the subjective benefit of NIR light devices in 
patients with perceived difficult peripheral intravenous access [6].  In addition, 
knowledge about the efficacy of these devices in the adult inpatient setting is mostly 
unknown.  The aim of the present study is to address these knowledge gaps. 

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Study Objectives 
 
The objective of this project is to define the effectiveness and therefore the role of NIR 
vein finders in adult patients with difficult peripheral venous access.  The specific 
objective of the proposed randomized controlled trial is to test the clinical success rate 
of placing peripheral venous catheters in ‘difficult’ access patients using traditional 
peripheral venous catheter placement compared to two established methods utilizing 
NIR vein imaging.  We hypothesize that the capability to successfully place lasting 
peripheral venous catheters is increased with the adjunct of the imaging technology, 
reducing the number of failed needle sticks, reducing the number of peripheral venous 
catheters placed throughout a patient’s hospital stay, and reducing the need for more 
invasive catheters such as PICC lines.  To test this hypothesis, we utilize a 
commercially available FDA-approved NIR vein finder which currently is already in 
clinical use at Lahey Hospital & Medical Center.  We are planning to conduct a 
randomized controlled trial recruiting patients who as part of their routine clinical care 
will require placement of a peripheral venous catheter and who are considered to have 
a difficult peripheral venous access.  Potential study patients will be randomized into 3 
groups: 
- Placement of peripheral venous catheter using conventional methods 
- 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 
- Identification of the most suitable target and placement of a peripheral venous 
catheter under constant imaging with a VeinViewer 
 
To achieve the goals of this project, we have assembled a highly interdisciplinary team 
with expertise in clinical peripheral venous catheter placement, biomedical device 
development, and biostatistics to pursue the following specific aims: 
 
Primary Objective 
• to assess the rate of successful initial placement of a peripheral venous catheter 
dependent on the method used 
 
Secondary Objectives 
• to compare variables representing the ease of peripheral venous catheter 
placement, complication rates, and durability of the catheter within each study 
treatment arm 

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Study Design 
 
Study Overview 
The proposed project is a randomized controlled trial involving in-hospital patients who 
receive routine care at Lahey Hospital & Medical Center, Burlington, MA and as part of 
their planned treatment are scheduled to undergo placement of a peripheral venous 
catheter in one of the upper extremities.  400 patients (age ≥18), who are scheduled 
and consented to undergo placement of a peripheral venous catheter in one of the 
upper extremities as part of routine clinical care and who meet the criteria listed below, 
will be enrolled.  Patient recruitment is expected to take 8 months.  Patients will be 
randomized to 1) placement of a peripheral venous catheter using conventional 
methods versus 2) use of NIR vein imaging to visualize the most suitable target and 
subsequent placement of a peripheral venous catheter using conventional methods 
versus 3) placement of a peripheral venous catheter under constant imaging with NIR 
vein imaging.  Clinical outcomes obtained will be recorded and analyzed. 
 
Eligibility Criteria 
The eligibility criteria were chosen to minimize the risk to the study patient by only 
including patients who are already planned to undergo placement of a peripheral 
venous catheter and by excluding any high-risk patients.  In order to be considered for 
the study, patients have to meet the following criteria: 
a) Inclusion criteria: 
• adult in-hospital patients (≥18 years of age, inpatient and outpatient setting) 
• willing to provide research authorization 
• scheduled and consented to undergo peripheral venous cannulation of one of 
the upper extremities to be performed by one of the members of the Vascular 
Access Team 
• determined to be a difficult peripheral venous access defined by one of the 
following criteria in alignment to the A-DIVA scale to be assessed by one of 
the members of the Vascular Access Team [8]: 
- failed inspection for more than one visible or palpable suitable vein 
through conventional methods 
- failed at least one attempt of peripheral venous cannulation through 
any methods 
- history of difficult peripheral venous access 
- greatest diameter of target vein less than 3mm determined by 
conventional methods 
 
b) Exclusion criteria: 
• clinical contraindication for placement of peripheral venous catheter, 
including: 
- severe bilateral upper extremity edema 
- severe bilateral upper extremity skin burn 
- severe bilateral upper extremity cellulitis 
- history of bilateral axillary lymphadenectomy 

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• known severe cardiovascular or pulmonary compromise demanding 
minimization of procedure time, such as: 
- severe shock with severe cardiovascular instability 
- active CPR 
- major uncontrolled hemorrhage 
- any condition for which the primary healthcare provider is requesting 
emergent venous access 
• scheduled PICC or midline catheter placement 
• non-English-speaking patients if an interpreter is not available 
• prisoner and any individual involuntarily confined or detained in a penal 
institution 
• impaired capacity to make informed medical decisions 
 
Recruitment 
In-hospital patients seen at Lahey Hospital & Medical Center who meet study criteria 
will be identified by a member of the hospital’s Vascular Access Team through direct 
referral by the patient’s clinical care provider.  Patients will be approached by the team 
member at the time of planned placement of a peripheral venous catheter.  For patients 
who are interested in participating in the study and who meet criteria, a verbal informed 
consent will be obtained in person by the team member.  In addition, a written brochure 
explaining the study will be provided.  An application for waiver of written consent will be 
submitted to the institution’s IRB.  Recruitment will continue until 400 patients who meet 
eligibility criteria have been enrolled. It is expected that patient recruitment for the study 
will be completed within 8 months. 
 
Informed Consent Process 
A written informed consent will be obtained in person from eligible patients by a member 
of the hospital’s Vascular Access Team at the time of planned placement of a peripheral 
venous catheter.  The team members have been trained regarding the required 
elements of information needed to be provided to the patient.  In addition, the patient 
will also receive the information in writing through a brochure provided to the patient at 
the time of consent.  An additional, unsigned copy of the consent form will be given to 
the patient at the time of consent.  The consent form itself will be collected and scanned 
into the patient’s electronic medical records at a later point.  A copy of the consent form 
will be archived in the study folder at a later point. 
 
The person obtaining consent from the study patient will give subjects detailed and 
comprehensive information about the study, its associated risks, benefits, expected 
outcomes, and alternative options.  For non-English-speaking patients, an interpreter 
will translate the provided consent information to the potential subject and interpret any 
questions for the Vascular Access Team member. 
 
Study patients may withdraw at any time by informing the Vascular Access Team 
member or the principal investigator verbally or in writing.  Yet, data already collected 
and/or generated prior to withdrawal will not be affected. 

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Study Procedures 
 
Imaging System To Be Utilized 
For the study purposes the commercially available FDA-approved VeinViewer Flex 
(Christie Medical Holdings, Inc., Memphis, Tennessee) will be utilized.  The device 
provides HD imaging and projection of NIR images at a minimum brightness of 5 
lumens.  The device weighs 0.7 kg and measures 11.6" x 4" x 1.7".  It is powered by 
standard lithium ion batteries or AC outlet.  The imaging focal distance is 30 cm.  The 
VeinViewer Flex uses no consumables, requires no patient contact, and does not 
provide any heat, laser-safety, eye-safety, or radiation concerns.  It is considered on 
FDA class I device and received 510(k) exempt approval for the intended use to 
indicate the location of blood vessels. 
 
 
Figure 2: VeinViewer Flex (Christie Medical Holdings, Inc., Memphis, TN) 
 
The device includes distinctive visualization modes through the provided VeinViewer 
ASSESS Imaging Suite.  These include: 
• Universal: provides the brightest and most accurate direct-projection, baseline 
mode 
Purpose: minimizing surface structures such as hair and wrinkles 
• Fine Detail: enhances finer structures 
Purpose: identifying small veins in pediatric patients 
• Inverse: switches/inverts colors within the image window 
Purpose: customizing the projected image based on factors such as skin 
tone, density of hair follicles, and room brightness 
• Resize: choice of one of three window sizes 
Purpose: for pediatric patients or when focus on only one vessel is needed 
• MaxBright: increases image brightness by an additional 40% 
Purpose: for scenarios where greater than standard ambient lighting is 
present 

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It is left to the discretion of the Vascular Access Team member to decide which mode is 
being used during the study procedure.  Yet, historically it is expected that most of the 
time the ‘Universal’ mode will be utilized. 
 
 
Figure 3: Visualization modes of the VeinViewer ASSESS Imaging Suite 
 
Training of Staff 
Each member of the Vascular Access Team involved in a study underwent formal 
training in the proper use of the VeinViewer device provided by the device manufacture 
or hospital.  In addition, each member had to use the device independently during 
routine patient care for at least 20 times before being able to participate in the study. 
Research training in the form of successful completion of the institutionally required CITI 
program is mandatory for each participating team member.  Additional training on the 
consent process was provided. 
 
Peripheral Venous Cannulation and Randomization of Study Groups 
Patients, who meet eligibility criteria and agree to participate in the study after an 
informed consent process, will undergo simple randomization.  A sealed envelope 
holding the information of the random assignment will be opened by the Vascular 
Access Team member.  Randomization will assign study patients into 1 of 3 
groups/treatment arms with a 1:1:1 ratio: 
• Placement of a peripheral venous catheter using conventional methods 
• Use of 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 
• Identification of the most suitable target and placement of a peripheral venous 
catheter under constant imaging with VeinViewer 
 
When the VeinViewer device will be utilized, multiple areas on the patient's upper 
extremities will be assessed looking for the most suitable access point according to 
routine clinical practice.  There is no restriction in regards to vein diameter, vein length, 
or relation of veins to joints.  The choice of the location for intravenous cannulation, the 
use of tourniquets, the use of heating devices, and any techniques to palpate the vein 
will be left to the discretion of the Vascular Access Team member based on routine 
clinical practice.  This study requires an unobstructed view of the subject’s arm under 
standard hospital lighting conditions. 
 
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. 
 

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Follow-Up (for in-patients only) 
A member of the Vascular Access Team will see the patient in person three days after 
peripheral venous cannulation and each day thereafter according to routine practice.  At 
the follow-up evaluation patency of the peripheral venous catheter and any 
complications associated with the peripheral venous catheter will be clinically assessed 
and documented.  Follow-up will be completed once the patient has been discharged 
from the hospital or once the peripheral venous catheter placed as part of the study has 
been removed or replaced. 
 
Data Collection 
The following variables will be assessed for all study patients at the time of peripheral 
venous cannulation: 
a) primary outcome measures: 
• 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) 
b) secondary outcome measures: 
• number of required needle sticks before successful placement of a peripheral 
venous catheter 
• type of method that resulted in successful placement of a peripheral venous 
catheter 
• number of visible veins suitable for cannulation (each continuous vein will be 
counted as one cannulation site) 
• IV catheter gauge size utilized after completion of IV cannulation 
• target vein location (bend of the elbow, forearm, back of hand, other) and side 
of extremity (right vs. left) 
• use of warming of arm 
• procedure time 
• procedure associated complications 
• Vascular Access Team member experience (years in practice) 
• Vascular Access Team member survey: 
- subjective difficulty locating a suitable vein 
- subjective difficulty of venous access 
- subjective reasons for the difficulty of identifying veins 
- subjective impression of locating additional veins with VeinViewer device 
- subjective impression of usefulness of the VeinViewer device in 
successful placement of a peripheral venous catheter 
• Patient survey: 
- usual number of IV attempts required 
- patients’ satisfaction after completion of IV cannulation 
c) clinical patient demographics will be derived from patient history and/or medical 
records: 
• age 
• gender 
• height 

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• weight 
• dominant hand 
• date of procedure 
 
The following variables will be assessed for all in-patient study subjects, if available, at 
the time of follow-up: 
• catheter patency / need for replacement of catheter / type of catheter used for 
replacement 
• presence of complications such as : 
- hematoma 
- phlebitis 
- thrombophlebitis 
- infiltration 
- nerve damage 
 
All abstracted data, including a study number for each patient, will be stored on a 
password-protected research database on a hospital server at Lahey Hospital & 
Medical Center.  Any identifier, except for date of procedure, will be removed after the 
follow-up has been completed. 

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Study Endpoints 
 
Study Endpoints 
The primary endpoint of the study will be to assess the rate of successful initial placement 
of a peripheral venous catheter in patients representing difficult venous access dependent 
on the method used.  Secondary endpoints include various measures of efficacy and 
quality of peripheral venous catheter placement as a factor of the method used.  The 
results will allow for estimation of the promise of NIR vein imaging for a future clinical 
use. 
 
Sample Size and Power Determination 
The study was designed such that we will need to enroll at least 125 patients per group 
(375 patients total for all three groups) to have 80% power if the estimated percentage 
with success in the control group is 50% and 70% in either of the study groups using a 
two-sided p<0.0167 for determining significance (study alpha was divide equally 
between the three groups). 
 
We have therefore chosen to include 400 patients in the study.  We anticipate that this 
initial data set will provide useful information regarding the effectiveness of the device in 
difficult access situations.  In addition, it will give information about variability of data 
between patients that will guide the design of any future device and further studies that 
will answer more specific clinical questions. 
 
Due to the need for appropriately trained staff to be available, the study will only be 
offered during hours when one of the trained Vascular Access Team members / co-
investigators is available.  During this time frame, the Vascular Access Team typically 
encounters approximately 50 patients per week.  We anticipate that approximately 40% 
of these patients will meet study inclusion criteria.  We estimate an approximate 60% 
study recruitment rate.  We therefore expect that approximately 12 patients will be 
recruited into the study per week.  The study is therefore estimated to be complete 
within 8 months. 
 
Data Analysis and Statistical Methods 
Direct study group comparison of the primary and secondary outcome variables will be 
performed using routine statistical tests utilizing a statistician at Tufts CTSI.  In addition, 
the study will collect limited descriptive information pertinent to the effectiveness of 
visualizing superficial peripheral veins. 

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Study Monitoring and Safety Plan 
 
Study Monitoring 
After the first patient has been enrolled, the principle investigator will review the 
collected data every four weeks with other members of the study staff.  At each 
research meeting, the principle investigator will evaluate study progress and assess 
protocol compliance.  This will include the informed consent procedure, compliance with 
eligibility criteria, and identification of protocol violations.  The principle investigator will 
also review all collected data to verify data accuracy, consistency, and integrity.  The 
patients will be physically evaluated 3 days after the procedure by a Vascular Access 
Team member according to routine practice, unless discharged home or otherwise not 
available in-hospital, to assess for procedure related adverse events.  The principle 
investigator will review any reports that could be pertinent to a potential adverse event.  
The principle investigator will be responsible for reviewing data from any adverse event 
and determining, if applicable, whether the research should be altered or stopped.  Any 
decision to alter or stop enrollment will be reported to the IRB. 
 
Any untoward medical event considered related or possibly related to study participation 
will be considered an adverse event.  Serious adverse events (SAE) will be defined as 
stated in the IRB SAE reporting policy.  Adverse events will be graded for severity 
according to NCI-CTCAE (version 4.0).  For the purpose of safety reporting, the study 
period will be considered from the day of the procedure to the day of the last follow-up.  
All adverse events of grade II or greater attributable to study participation will be 
reported to the IRB.  Multiple occurrences of an adverse event that, based on an 
aggregate analysis, is determined to be an unanticipated problem independent of the 
severity grade will be reported to the IRB.  Any SAEs related to study participation will 
be reported within 5 business days of the PI learning of the event. 
 
Protection of Human Subjects 
Non-invasive vein visualization devices are FDA class 1 devices (CFR title 21 section 
880.6970).  The VeinViewer Flex device (Christie Medical Holdings, Inc., Memphis, TN) 
used for this study is registered with the FDA for the intended use to indicate the 
location 
of 
blood 
vessels 
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=241896&lpcd=KZA)
.  The device will be used in accordance with its labeling (IDE exempt under CFR title 
21 section 812.2(c) category 2).  Using the VeinViewer in the setting outlined in the 
inclusion criteria would represent standard of care (i.e. each study arm represents a 
form of standard of care currently practiced at Lahey Hospital & Medical Center).  With 
the use of NIR light, the patient is not exposed to any significant energy or potential for 
harm.  We therefore conclude that the proposed device is a non-significant risk 
device qualifying for an IDE exemption. 
 
Risks 
Complications associated with peripheral venous access placement such as 
hematomas, phlebitis, thrombophlebitis, infiltration, and nerve damage can occur.  
However, since only patients will be included who under best medical practice would 

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undergo placement of a peripheral venous cannula anyhow, the potential added 
research risk to the study patients is minimal.  Specifically, the risk of complications 
during peripheral venous cannula placement with the use of the VeinViewer is thought 
to be not greater than with the use of regular eyesight.  The risk of the VeinViewer 
disturbing the flow of patient care is also felt to be insignificant due to the exclusion of 
patient's demanding minimization of procedure time. 
 
Concerning the clinical patient information collected in the research database, all patient 
identifying information will be kept to a minimum and will only include medical record 
number and date of procedure.  Furthermore, the data abstracted will be stored in a 
password-protected hospital server.  No patient identifiers will be sent outside of Lahey 
Hospital, published, or be provided to anyone outside of the research team.  Patient 
identifiers, except for date of the procedure, will be discarded after the last follow-up. 
 
We therefore conclude that the proposed study represents minimal risk. 
 
Benefits and Alternatives 
At present, insufficient evidence exists to characterize the effectiveness of this imaging 
technique; particularly in the setting of a difficult peripheral venous access.  Therefore, 
study participation does not provide any proven benefit to the patient. 
 
Apart from not participating in the study and pursuing standard/routine treatment 
options, there are no alternative options for any potential study patient.  The patient's 
participation in this research study is voluntary.  At any time, he or she may choose not 
to participate in this research study simply by contacting the principal investigator or a 
study team member.  If the patient decides to withdraw consent to participate in the 
study after placement of the peripheral venous cannula, no new data about the patient 
will be collected for study purposes unless the data concerns an adverse event related 
to the study.  Yet, all data that has already been collected for study purposes will 
continue to be used and analyzed. 
 
Importance of the Knowledge To Be Gained 
Currently, finding a suitable peripheral vein for access continues to be a frequent 
challenge for healthcare providers and a significant burden to the patient; issues that 
are hoped to be addressed by the study device.  Due to the sheer volume of peripheral 
venous catheter placements within the in-hospital setting and the associated detriments 
to the patient when repeated attempts are needed, any improvement in reducing the 
number of attempts of peripheral vein cannulations, prolonging the patency of these 
catheters, and reducing catheter associated complications can have a significant impact 
on overall patient care throughout the entire in-hospital patient population. 
 
The proposed clinical trial will establish the potential of incorporating a novel NIR vein 
finder into clinical practice to improve peripheral venous access for in-hospital patients 
who are considered a ‘difficult stick’.  Incorporation of such devices, if found to be 
successful, can fundamentally change patients’ experience and reduce complication 
rates. 

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Limitations 
Overall it is felt that the study has a very robust design.  Yet, limitations include bias by 
any Vascular Access Team member who may favor one method and therefore might 
create more favorable results with the method of subjective preference (observer-
expectancy effect and experimenter bias). 
 
The follow-up was felt to be adequate since most complications are expected to present 
during the hospital stay.  However, long-term complications, such as thrombophlebitis, 
might be slightly underestimated due to its sometimes later presentation even after 
removal of the catheter or in patients who have been transferred to a different facility 
with the catheter still in place.  Nevertheless, there is currently no reason to believe that 
long-term outcomes of a successful peripheral venous catheter are dependent on the 
method of catheter placement and therefore it is not expected that the study results will 
significantly be affected. 
 
NIR vein imaging might require a learning curve. To minimize the issue, all Vascular 
Access Team members have been trained with the device and had to use the device 
independently during routine patient care for at least 20 cases before being able to 
participate in the study. 

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Study Resources and Finances 
 
Institutional Resources 
The study utilizes several existing resources available at Lahey Hospital & Medical 
Center.  This does include the completed purchase of two VeinViewer devices which 
are already in clinical use at the institution. 
 
The Vascular Access Team at Lahey Hospital & Medical Center performs approximately 
10 peripheral venous access placements in the inpatient setting per day during regular 
business hours.  The Vascular Access Team leader and members of the Vascular 
Access Team are investigators or collaborators of the study.  The study is supported by 
the Department of Surgery at Lahey Hospital & Medical Center. 
 
Support for statistical questions will be obtained through an established collaboration 
with the Clinical and Translational Science Institute at Tufts University. 
 
Financial Resources 
The study is supported through the institutional infrastructure.  The cost of statistical 
analysis will be covered through departmental funds. 
 
Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, 
royalties, or financial gain greater than the minimum allowable by Lahey Health 
Corporate Compliance, etc.) cannot participate in this study. All investigators will follow 
the applicable Lahey Health conflict of interest policies. 

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