Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00357799
Status:
COMPLETED
Last Update Posted:
2011-08-24
First Post:
2006-07-26
Brief Title:
VeinViewer for Peripheral IV Placement in Children With Difficult Intravenous IV Access
Sponsor:
Childrens Hospital and Health System Foundation Wisconsin
Organization:
Childrens Hospital and Health System Foundation Wisconsin
Study Overview
Official Title:
VeinViewer for Peripheral IV Placement in Children With Difficult IV Access
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis The first attempt success rate for peripheral IV insertion for children with difficult IV access difficult IV access DIVA score 4 by nurses using the VeinViewer guided technique is better than conventional method of IV placement
Specific Aims
1 To investigate if use of the VeinViewer can improve the success of peripheral IV placement in children with difficult IV access
2 To validate the DIVA score
Design Prospective randomized controlled trialConvenience sample
Subjects Children 0-18 presenting to the emergency department who require an IV as determined by examining physician and with a DIVA score 3 during times when VeinViewer machine is available and a VeinViewer trained participating nurse is on duty
Variables
Outcome Variables First IV attempt success rate
Predictor Variables IV technique used other potential modifiers age weight height skin shade indication for IV history of prematurity and vein visibilitypalpability after tourniquet
Methods Subjects who meet inclusion criteria will be randomized to either conventional IV technique or VeinViewer guided technique The nurse will attempt the IV depending on the randomization Success or failure on first IV attempt will be recorded If unsuccessful other attempts will be tried until a successful IV is placed or the physician decides to give an alternative therapy that does not need IV access
Statistics A chi square test will be used to compare the proportion of subjects with successful first attempt IV placement using the VeinViewer technique to that using the conventional method with 95 confidence interval We the researchers will look at the median number of attempts to place an IV in each of the groups Logistic regression will be performed to test for independent associations Information collected during the study will also be used for validation of the DIVA score
Risks No extra risks are expected above that of receiving a standard IV The standard risk of bleeding bruising pain and infection will be possible regardless of technique used The VeinViewer does not expose the patient the ionizing radiation The use of the VeinViewer technique may increase the time need to place an IV in
Potential Benefits With this study we the researchers hope to improve the success rate of children with difficult IV placement in the Emergency Department
Specific Aims
1 To investigate if use of the VeinViewer can improve the success of peripheral IV placement in children with difficult IV access
2 To validate the DIVA score
Design Prospective randomized controlled trialConvenience sample
Subjects Children 0-18 presenting to the emergency department who require an IV as determined by examining physician and with a DIVA score 3 during times when VeinViewer machine is available and a VeinViewer trained participating nurse is on duty
Variables
Outcome Variables First IV attempt success rate
Predictor Variables IV technique used other potential modifiers age weight height skin shade indication for IV history of prematurity and vein visibilitypalpability after tourniquet
Methods Subjects who meet inclusion criteria will be randomized to either conventional IV technique or VeinViewer guided technique The nurse will attempt the IV depending on the randomization Success or failure on first IV attempt will be recorded If unsuccessful other attempts will be tried until a successful IV is placed or the physician decides to give an alternative therapy that does not need IV access
Statistics A chi square test will be used to compare the proportion of subjects with successful first attempt IV placement using the VeinViewer technique to that using the conventional method with 95 confidence interval We the researchers will look at the median number of attempts to place an IV in each of the groups Logistic regression will be performed to test for independent associations Information collected during the study will also be used for validation of the DIVA score
Risks No extra risks are expected above that of receiving a standard IV The standard risk of bleeding bruising pain and infection will be possible regardless of technique used The VeinViewer does not expose the patient the ionizing radiation The use of the VeinViewer technique may increase the time need to place an IV in
Potential Benefits With this study we the researchers hope to improve the success rate of children with difficult IV placement in the Emergency Department
Detailed Description:
Introduction
Attempting to get peripheral intravenous IV access can be one of the most frustrating and irksome tasks medical professionals encounter Many medical therapies require the placement of an IV In an emergency situation it can be the lifeline that makes the difference between a good or bad outcome Determinants of successful IV placement include the skill and expertise of the person who places the IV the veins of the person who receives the IV and luck
These difficulties are often magnified in children Children have smaller veins Children come in different sizes and shapes Children are often uncooperative Not uncommonly multiple attempts at IV placement are required before success The more attempts that are needed to get an IV placed the more pain and anxiety a child experiences Getting an IV in a timely manner can alter parental perceptions of the quality of care and improve parental satisfaction Developing methods to improve success rate of IV placement has obvious benefits
During a previous study we were able to demonstrate that in 25 of the patients in our pediatric emergency department who have an IV placement attempt will fail the first IV attempt We were able to develop a scoring system termed DIVA score that we believe will aid in identifying those more likely to have a failed first IV attempt and so therefore may more likely benefit from our intervention VeinViewer By attempting to demonstrate improved success on those with an increase likelihood of failure on first IV attempt we believe that we will decrease the number of subjects needed to show an effect and to limit this potentially resource intensive technique to those most likely to benefit
The VeinViewer is an infrared imaging system that utilizes near-infrared light and other technologies to project a real-time image of the location and orientation up to 006mm of veins onto the surface of patients skin The VeinViewer received FDA clearance in August 2004 as a class I device The VeinViewers Infrared Light is considered harmless We believe a potential application for the VeinViewer is to improve the success rate of IV insertion in
Objectives
1 To investigate if use of the VeinViewer can improve the success of peripheral IV placement in children with difficult IV access DIVA score 3
2 To validate the DIVA difficult IV access score
Hypothesis
1 The first stick success rate for peripheral IV insertion for children with difficult IV access in a pediatric emergency department DIVA score 3 by registered nurses using VeinViewer guided technique is better than conventional method of IV placement
2 The DIVA score is a valid scoring system to identify those who are more likely to have failed first IV attempt
Methods
Study Design Prospective randomized controlled trial
Randomization Subjects will be randomized to either get the VeinViewer technique or the conventional method Serially number sealed opaque study packets with the blocked randomization will be created
Subjects
Inclusion criteria
Presentation to the ED at the CHW
0 to 19 years of age
Requires a peripheral IV as determined by the examining physician
DIVA score 3 a clinical scoring system that identifying difficult IV access that gives 2 points for vein not visible after tourniquet 2 for vein not palpable after tourniquet 1 for age 1-2yo 3 for age 1 yo 3 for history of prematurity
During times when VeinViewer machine and participating nurse is available
Exclusion criteria
Central line available
Immunocompromised patient
Requirement for immediate IV placement Patients condition would potentially be compromised if there is a time delay in IV placement
Patients who present to the emergency department and whom an IV is ordered will be screened for inclusion in the study by research assistants nursing or investigators A DIVA score will be determined Those with a score 3 will be approached to take part in the study Informed parental consent will be obtained Patient assent will be obtained for children 7 years of age and older
Measurements
Predictor Variables VeinViewer or conventional methods
Main Outcome Variable Success or failure of peripheral IV placement on first attempt
Secondary Outcome Variable Number of attempts to successful IV placement
Data to be collected potential modifiers for successful IV placement
Age Date of Birth
Number of IV attempts until success or quitting
Date of visit
Location of IV attempts
Weight
Reason for IV Fluid medication other
Height
Dermablend skin color category
History of prematurity
Pre-attempt analgesia used
Vein visibility after tourniquet
Vein palpability after tourniquet
Technique used VeinViewerConventional technique
Conventional method
A tourniquet is applied The nurse identifies a target vein visually and tactilely in one of several areas of possible IV sites dorsum of the hand antecubital fossa or forearm The area is cleaned with an alcohol pad The nurse then inserts an 18-24 gauge IV needlecatheter and looks for a flashback The tourniquet is released The IV is then flushed If the IV flushes well then the IV is secured in the usual manner A secured flushed IV is the definition of a successful IV placement
VeinViewer technique
A tourniquet is applied Using the VeinViewer the nurse identifies a vein for cannulation A tourniquet is applied The nurse then attempts to insert an 18-24 gauge IV needlecatheter and looks for a flashback The tourniquet is released The IV is then flushed If the IV flushes well then the IV is secured in the usual manner A secured flushed IV is the definition of a successful IV placement
Subsequent Attempts
If unsuccessful with first attempt at IV placement an attempt at another site with the same technique VeinViewer guided or conventional method will be performed This will be repeated until a successful IV is placed or the physician decides to give an alternative therapy that does not need IV access
We plan to monitor the success rate for DIVA patients who are not enrolled in the study to demonstrate that they are comparable to our control group
Planned Analysis
VeinViewer vs Conventional method
The main outcome is success or failure of peripheral IV placement on first attempt a dichotomous outcome A Chi square test will be used to compare the proportion of subjects with successful first stick IV placement using the VeinViewer technique to that using the conventional method with 95 confidence intervals around the difference Also planned is to look at the median number of attempts to place IV with each of the different methods of IV placement We plan to use a non-parametric test like the Wilcoxon Rank sum test To test for independent associations between VeinViewer technique or conventional method for IV placement and success or failure of IV placement on first attempt multivariate logistic regression will be performed with potential confounding variables patient weight diagnosis etc included as co-variates in the model We plan to use an interaction term in the model that will take in account that there may be a learning curve for the technique nurses early in the study vs nurses later in the study
DIVA score validation
The patients whose information we collected validation cohort in this study will be used to validate the DIVA score We will determine first attempt success rate with conventional IV placement method at each DIVA score in both the derivation cohort from data previously collected in the derivation study and the validation cohort We will use chi-square statistics to compare derivation and validation cohorts The areas under the receiver operating characteristics curves for predicting successful IV placement on first attempt at each DIVA score will be compared between the derivation and validation cohorts Attempts will be made to refine the score should analysis demonstrates that it is warranted
Estimated sample size calculation From a previous study we demonstrated that patients with a DIVA score 3 had a more than 45 first attempt failure rate for peripheral IV placement using the conventional method A technique that can improve success by 25 would be considered significant Using alpha of 005 beta of 010 Power 090 and making the question two-tailed we find an estimated sample size in each group of 85 In other words 170 children with DIVA 3 will be needed for our study
Risk to Subjects
There are no extra risks expected above that of receiving a standard IV The standard risks of IV include bleeding bruising pain and infection The use of the VeinViewer technique may or may not take more time to place an IV If a delay would be detrimental to the subjects care they will not be asked to take part in this study
Anticipated significance of the study
A technique that improves the first stick success rate or decreases the number of sticks required to place an IV would decrease amount of pain discomfort and anxiety for the patient Getting an IV in a timely manner can alter parental perceptions of the quality of care and improve parental satisfaction Also this may be a time saver for nurses
Attempting to get peripheral intravenous IV access can be one of the most frustrating and irksome tasks medical professionals encounter Many medical therapies require the placement of an IV In an emergency situation it can be the lifeline that makes the difference between a good or bad outcome Determinants of successful IV placement include the skill and expertise of the person who places the IV the veins of the person who receives the IV and luck
These difficulties are often magnified in children Children have smaller veins Children come in different sizes and shapes Children are often uncooperative Not uncommonly multiple attempts at IV placement are required before success The more attempts that are needed to get an IV placed the more pain and anxiety a child experiences Getting an IV in a timely manner can alter parental perceptions of the quality of care and improve parental satisfaction Developing methods to improve success rate of IV placement has obvious benefits
During a previous study we were able to demonstrate that in 25 of the patients in our pediatric emergency department who have an IV placement attempt will fail the first IV attempt We were able to develop a scoring system termed DIVA score that we believe will aid in identifying those more likely to have a failed first IV attempt and so therefore may more likely benefit from our intervention VeinViewer By attempting to demonstrate improved success on those with an increase likelihood of failure on first IV attempt we believe that we will decrease the number of subjects needed to show an effect and to limit this potentially resource intensive technique to those most likely to benefit
The VeinViewer is an infrared imaging system that utilizes near-infrared light and other technologies to project a real-time image of the location and orientation up to 006mm of veins onto the surface of patients skin The VeinViewer received FDA clearance in August 2004 as a class I device The VeinViewers Infrared Light is considered harmless We believe a potential application for the VeinViewer is to improve the success rate of IV insertion in
Objectives
1 To investigate if use of the VeinViewer can improve the success of peripheral IV placement in children with difficult IV access DIVA score 3
2 To validate the DIVA difficult IV access score
Hypothesis
1 The first stick success rate for peripheral IV insertion for children with difficult IV access in a pediatric emergency department DIVA score 3 by registered nurses using VeinViewer guided technique is better than conventional method of IV placement
2 The DIVA score is a valid scoring system to identify those who are more likely to have failed first IV attempt
Methods
Study Design Prospective randomized controlled trial
Randomization Subjects will be randomized to either get the VeinViewer technique or the conventional method Serially number sealed opaque study packets with the blocked randomization will be created
Subjects
Inclusion criteria
Presentation to the ED at the CHW
0 to 19 years of age
Requires a peripheral IV as determined by the examining physician
DIVA score 3 a clinical scoring system that identifying difficult IV access that gives 2 points for vein not visible after tourniquet 2 for vein not palpable after tourniquet 1 for age 1-2yo 3 for age 1 yo 3 for history of prematurity
During times when VeinViewer machine and participating nurse is available
Exclusion criteria
Central line available
Immunocompromised patient
Requirement for immediate IV placement Patients condition would potentially be compromised if there is a time delay in IV placement
Patients who present to the emergency department and whom an IV is ordered will be screened for inclusion in the study by research assistants nursing or investigators A DIVA score will be determined Those with a score 3 will be approached to take part in the study Informed parental consent will be obtained Patient assent will be obtained for children 7 years of age and older
Measurements
Predictor Variables VeinViewer or conventional methods
Main Outcome Variable Success or failure of peripheral IV placement on first attempt
Secondary Outcome Variable Number of attempts to successful IV placement
Data to be collected potential modifiers for successful IV placement
Age Date of Birth
Number of IV attempts until success or quitting
Date of visit
Location of IV attempts
Weight
Reason for IV Fluid medication other
Height
Dermablend skin color category
History of prematurity
Pre-attempt analgesia used
Vein visibility after tourniquet
Vein palpability after tourniquet
Technique used VeinViewerConventional technique
Conventional method
A tourniquet is applied The nurse identifies a target vein visually and tactilely in one of several areas of possible IV sites dorsum of the hand antecubital fossa or forearm The area is cleaned with an alcohol pad The nurse then inserts an 18-24 gauge IV needlecatheter and looks for a flashback The tourniquet is released The IV is then flushed If the IV flushes well then the IV is secured in the usual manner A secured flushed IV is the definition of a successful IV placement
VeinViewer technique
A tourniquet is applied Using the VeinViewer the nurse identifies a vein for cannulation A tourniquet is applied The nurse then attempts to insert an 18-24 gauge IV needlecatheter and looks for a flashback The tourniquet is released The IV is then flushed If the IV flushes well then the IV is secured in the usual manner A secured flushed IV is the definition of a successful IV placement
Subsequent Attempts
If unsuccessful with first attempt at IV placement an attempt at another site with the same technique VeinViewer guided or conventional method will be performed This will be repeated until a successful IV is placed or the physician decides to give an alternative therapy that does not need IV access
We plan to monitor the success rate for DIVA patients who are not enrolled in the study to demonstrate that they are comparable to our control group
Planned Analysis
VeinViewer vs Conventional method
The main outcome is success or failure of peripheral IV placement on first attempt a dichotomous outcome A Chi square test will be used to compare the proportion of subjects with successful first stick IV placement using the VeinViewer technique to that using the conventional method with 95 confidence intervals around the difference Also planned is to look at the median number of attempts to place IV with each of the different methods of IV placement We plan to use a non-parametric test like the Wilcoxon Rank sum test To test for independent associations between VeinViewer technique or conventional method for IV placement and success or failure of IV placement on first attempt multivariate logistic regression will be performed with potential confounding variables patient weight diagnosis etc included as co-variates in the model We plan to use an interaction term in the model that will take in account that there may be a learning curve for the technique nurses early in the study vs nurses later in the study
DIVA score validation
The patients whose information we collected validation cohort in this study will be used to validate the DIVA score We will determine first attempt success rate with conventional IV placement method at each DIVA score in both the derivation cohort from data previously collected in the derivation study and the validation cohort We will use chi-square statistics to compare derivation and validation cohorts The areas under the receiver operating characteristics curves for predicting successful IV placement on first attempt at each DIVA score will be compared between the derivation and validation cohorts Attempts will be made to refine the score should analysis demonstrates that it is warranted
Estimated sample size calculation From a previous study we demonstrated that patients with a DIVA score 3 had a more than 45 first attempt failure rate for peripheral IV placement using the conventional method A technique that can improve success by 25 would be considered significant Using alpha of 005 beta of 010 Power 090 and making the question two-tailed we find an estimated sample size in each group of 85 In other words 170 children with DIVA 3 will be needed for our study
Risk to Subjects
There are no extra risks expected above that of receiving a standard IV The standard risks of IV include bleeding bruising pain and infection The use of the VeinViewer technique may or may not take more time to place an IV If a delay would be detrimental to the subjects care they will not be asked to take part in this study
Anticipated significance of the study
A technique that improves the first stick success rate or decreases the number of sticks required to place an IV would decrease amount of pain discomfort and anxiety for the patient Getting an IV in a timely manner can alter parental perceptions of the quality of care and improve parental satisfaction Also this may be a time saver for nurses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None