MedPath

Antegrade Versus Retrograde IV for Blood Draws

Not Applicable
Completed
Conditions
There is no Focus on Any Specific Condition
Interventions
Procedure: Peripheral intravenous catheter placement
Other: Blood draw
Device: Peripheral intravenous catheter
Drug: To keep open (TKO) infusion of 0.9% normal saline
Registration Number
NCT03533777
Lead Sponsor
University of Iowa
Brief Summary

The purpose of this study is to compare success rates of antegrade and retrograde intravenous (IV) catheters in their ability to aspirate 20 milliliter blood sample within a 2 minute time frame, 3 hours after initial insertion. Antegrade IV catheters are placed identically to conventional IV catheters, with the end of the catheter pointed toward the direction of blood flow to the heart. Retrograde catheters are placed "backwards" with the end of the catheter pointed away from the direction of venous blood flow. The hypothesis is that retrograde IVs will have a significantly higher success rate of blood draw at the 3 hour time mark without use of a proximal tourniquet.

Detailed Description

1. Patients scheduled for surgery under general anesthesia at the University of Iowa Hospitals and Clinics (UIHC) will be recruited pre-operatively in the Day of Surgery Admissions (DoSA) rooms before their surgery takes place. Once the subject is recruited and has signed a consent form, they will be randomized to either retrograde or antegrade IV. Once in the operating room and general anesthesia has been induced, a 20 gauge 30 millimeter catheter will be placed in a vein of one of the upper extremities by an anesthesiologist member of the research team. A drape will obscure viewing of the procedure by the clinical anesthesia provider. They will then connect the catheter to an IV tubing set and cover the insertion site with a opaque towel, so as to blind the anesthesia provider caring for the patient in the OR.

2. 0.9% normal saline (NS) will be infused at a rate of 20 milliliters (mL) per hour to keep it open (TKO) and it will not be used for drug infusion.

3. Three hours after insertion, the anesthesia provider in the OR will attempt a blood draw from a stopcock 33 inches from the catheter. A successful 20 mL blood draw must be achieved within 2 minutes after attempt is started or it will be defined as a failed attempt. If blood draw fails, an upper arm tourniquet will be placed and the blood draw will be reattempted following the same guidelines as the initial attempt. After every blood draw, 10 mL of NS will be flushed back through the IV.

4. At the end of surgery, within 30 minutes of extubation, the anesthesia provider in the OR will attempt a blood draw from a stopcock 33 inches from the catheter. A successful 20 mL blood draw must be achieved within 2 minutes after attempt is started or it will be defined as a failed attempt. If blood draw fails, an upper arm tourniquet will be placed and the blood draw will be reattempted following the same guidelines as the initial attempt. After every successful blood draw 10 mL of NS will be flushed back through the IV.

5. The IV will be saline locked at the end of the case.

6. The IV will be removed within 15 minutes upon arrival in the Post Anesthesia Care Unit (PACU) by the same anesthesiologist member of the research team who placed it and the site will be dressed appropriately.

7. Follow up will happen on post-operative Day 1 (POD1) either in person if the patient is admitted to a UIHC inpatient unit or via a phone call if they are discharged before POD1. At this POD1 check, the patient will be asked about the prior IV site: level of pain, if there is a hematoma, or possible infection. There will be a maximum of 3 attempts to contact the subject. This data will be gathered by a research coordinator member of the research team who is unaware of which study arm the subject was randomized to.

8. A second follow up will happen on 14 days after the surgery/IV placement via a phone call. Again, the patient will be asked about the prior IV site: level of pain, if there is a hematoma, or possible infection. There will be a maximum of 3 attempts to contact the subject. This data will be gathered by a research coordinator member of the research team who is unaware of which study arm the subject was randomized to.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
230
Inclusion Criteria
  • Adult patients
  • English speaking
  • Age 18-90
  • Scheduled to undergo surgery under general anesthesia at the University of Iowa Hospitals and Clinics
  • Surgery is scheduled to last at least 3 hours
Exclusion Criteria
  • Emergency surgery
  • Previous or planned sentinel node dissection on ipsilateral arm of study IV
  • Existing or planned arteriovenous fistula on ipsilateral arm of study IV
  • Surgery with lateral positioning
  • Surgery which involves tucking the arm with study IV
  • Any additional peripheral IV catheters distal to study IV
  • Non invasive blood pressure cuff placed on arm with study IV

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Antegrade Intravenous CatheterTo keep open (TKO) infusion of 0.9% normal salineA 20 gauge 30 millimeter peripheral intravenous catheter will be placed in an upper extremity vein in standard antegrade fashion (with the tip pointed towards the direction of blood flow). Blood draws from this IV catheter will be attempted twice throughout the study. An infusion of 0.9% normal saline will be connected to the catheter and infused at a rate of 20 milliliters per hour to keep open (TKO) for future use by preventing blood clot development within the catheter.
Antegrade Intravenous CatheterPeripheral intravenous catheterA 20 gauge 30 millimeter peripheral intravenous catheter will be placed in an upper extremity vein in standard antegrade fashion (with the tip pointed towards the direction of blood flow). Blood draws from this IV catheter will be attempted twice throughout the study. An infusion of 0.9% normal saline will be connected to the catheter and infused at a rate of 20 milliliters per hour to keep open (TKO) for future use by preventing blood clot development within the catheter.
Retrograde Intravenous CatheterPeripheral intravenous catheterA 20 gauge 30 millimeter peripheral intravenous catheter will be placed in an upper extremity vein in a retrograde fashion (with the tip pointed away from the direction of blood flow). Blood draws from this IV catheter will be attempted twice throughout the study. An infusion of 0.9% normal saline will be connected to the catheter and infused at a rate of 20 milliliters per hour to keep open (TKO) for future use by preventing blood clot development within the catheter.
Retrograde Intravenous CatheterTo keep open (TKO) infusion of 0.9% normal salineA 20 gauge 30 millimeter peripheral intravenous catheter will be placed in an upper extremity vein in a retrograde fashion (with the tip pointed away from the direction of blood flow). Blood draws from this IV catheter will be attempted twice throughout the study. An infusion of 0.9% normal saline will be connected to the catheter and infused at a rate of 20 milliliters per hour to keep open (TKO) for future use by preventing blood clot development within the catheter.
Retrograde Intravenous CatheterPeripheral intravenous catheter placementA 20 gauge 30 millimeter peripheral intravenous catheter will be placed in an upper extremity vein in a retrograde fashion (with the tip pointed away from the direction of blood flow). Blood draws from this IV catheter will be attempted twice throughout the study. An infusion of 0.9% normal saline will be connected to the catheter and infused at a rate of 20 milliliters per hour to keep open (TKO) for future use by preventing blood clot development within the catheter.
Antegrade Intravenous CatheterPeripheral intravenous catheter placementA 20 gauge 30 millimeter peripheral intravenous catheter will be placed in an upper extremity vein in standard antegrade fashion (with the tip pointed towards the direction of blood flow). Blood draws from this IV catheter will be attempted twice throughout the study. An infusion of 0.9% normal saline will be connected to the catheter and infused at a rate of 20 milliliters per hour to keep open (TKO) for future use by preventing blood clot development within the catheter.
Antegrade Intravenous CatheterBlood drawA 20 gauge 30 millimeter peripheral intravenous catheter will be placed in an upper extremity vein in standard antegrade fashion (with the tip pointed towards the direction of blood flow). Blood draws from this IV catheter will be attempted twice throughout the study. An infusion of 0.9% normal saline will be connected to the catheter and infused at a rate of 20 milliliters per hour to keep open (TKO) for future use by preventing blood clot development within the catheter.
Retrograde Intravenous CatheterBlood drawA 20 gauge 30 millimeter peripheral intravenous catheter will be placed in an upper extremity vein in a retrograde fashion (with the tip pointed away from the direction of blood flow). Blood draws from this IV catheter will be attempted twice throughout the study. An infusion of 0.9% normal saline will be connected to the catheter and infused at a rate of 20 milliliters per hour to keep open (TKO) for future use by preventing blood clot development within the catheter.
Primary Outcome Measures
NameTimeMethod
Ability to aspirate blood samples without tourniquet 3 hours after IV insertionthree hours after IV insertion

As compared to IV catheters placed in the standard antegrade fashion, do IV catheters placed in a retrograde direction have a higher blood draw success rate 3 hours after initial insertion, without the use of a tourniquet? Investigators define "blood draw success" as the ability to aspirate 20 mL blood samples within a 2 minute time frame. It is defined as a binary outcome variable: success vs failure. For the primary comparison of success rates in the retrograde vs antegrade IV groups, chi-square test will be used.

Secondary Outcome Measures
NameTimeMethod
Ability to aspirate blood samples with tourniquet (if needed) 3 hours after IV insertionthree hours after IV insertion

As compared to IV catheters placed in the standard antegrade fashion, do IV catheters placed in a retrograde direction have a higher blood draw success rate 3 hours after initial insertion, with the use of a tourniquet (if needed)? Investigators define "blood draw success" as the ability to aspirate 20 mL blood samples within a 2 minute time frame. It is defined as a binary outcome variable: success vs failure. For the primary comparison of success rates in the retrograde vs antegrade IV groups, chi-square test will be used.

Ability to aspirate blood samples with tourniquet (if needed) at the end of surgerythree to eight hours after IV insertion

As compared to IV catheters placed in the standard antegrade fashion, do IV catheters placed in a retrograde direction have a higher blood draw success rate greater than 3 hours after initial insertion, with the use of a tourniquet (if needed)? Investigators define "blood draw success" as the ability to aspirate 20 mL blood samples within a 2 minute time frame. It is defined as a binary outcome variable: success vs failure. For the primary comparison of success rates in the retrograde vs antegrade IV groups, chi-square test will be used.

Body mass index (BMI) as a predictor of success rate of blood draws 3 hours after IV insertion.three hours after IV insertion

As an exploratory analyses, the effect of BMI as a predictor of success rate of blood draws will be assessed by including the BMI in the logistic regression model where the outcome of interest is the successful blood draw 3 hours after initial insertion.

Ability to aspirate blood samples without tourniquet at the end of surgerythree to eight hours after IV insertion

As compared to IV catheters placed in the standard antegrade fashion, do IV catheters placed in a retrograde direction have a higher blood draw success rate greater than 3 hours after initial insertion, without the use of a tourniquet? Investigators define "blood draw success" as the ability to aspirate 20 mL blood samples within a 2 minute time frame. It is defined as a binary outcome variable: success vs failure. For the primary comparison of success rates in the retrograde vs antegrade IV groups, chi-square test will be used.

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics

🇺🇸

Iowa City, Iowa, United States

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