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Antegrade Versus Retrograde IV for Blood Draws

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University of Iowa

Status

Completed

Conditions

There is no Focus on Any Specific Condition

Treatments

Procedure: Peripheral intravenous catheter placement
Drug: To keep open (TKO) infusion of 0.9% normal saline
Other: Blood draw
Device: Peripheral intravenous catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT03533777
201805706

Details and patient eligibility

About

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.

Full 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.

Enrollment

230 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

230 participants in 2 patient groups

Antegrade Intravenous Catheter
Active Comparator group
Description:
A 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.
Treatment:
Other: Blood draw
Procedure: Peripheral intravenous catheter placement
Device: Peripheral intravenous catheter
Drug: To keep open (TKO) infusion of 0.9% normal saline
Retrograde Intravenous Catheter
Experimental group
Description:
A 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.
Treatment:
Other: Blood draw
Procedure: Peripheral intravenous catheter placement
Device: Peripheral intravenous catheter
Drug: To keep open (TKO) infusion of 0.9% normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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