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Antegrade Versus Retrograde IV for Blood Draws

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ClinicalTrials.gov Identifier: NCT03533777
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Feider, 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.

Condition or disease Intervention/treatment Phase
There is no Focus on Any Specific Condition Procedure: Peripheral intravenous catheter placement Other: Blood draw Device: Peripheral intravenous catheter Drug: To keep open (TKO) infusion of 0.9% normal saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study participants will be randomized to either antegrade or retrograde IV catheter placement. Although 267 patients were consented/enrolled in the study, only 230 patients were ultimately randomized. 37 patients were withdrawn from the study prior to randomization because they no longer met inclusion/exclusion criteria.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Placement of the IV catheter will occur after the subject is placed under general anesthesia and will be removed immediately upon arrival in the post-anesthesia care unit (PACU). Thus, the study participant will be unaware of which study arm they were in. An anesthesiologist member of the research team will place the IV immediately after randomization in the operating room. They will have a drape obscuring the view from the clinical anesthesia provider and will cover the IV with an opaque towel after insertion. Thus, the care provider will not have knowledge of which treatment arm their patient is randomized to. Intraoperative data will be gathered by the anesthesia care provider and postoperative questionnaire data will be gathered by a research coordinator member of the study team. The anesthesiologist who placed the study IV will not gather or have access to any of the subsequent data gathered on the study subject.
Primary Purpose: Supportive Care
Official Title: Comparison of Retrograde and Antegrade Peripheral Intravenous Cannulation on the Ability to Aspirate Blood Samples in the Operating Room
Actual Study Start Date : June 22, 2018
Actual Primary Completion Date : June 19, 2019
Actual Study Completion Date : June 19, 2019

Arm Intervention/treatment
Active Comparator: Antegrade Intravenous Catheter
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.
Procedure: Peripheral intravenous catheter placement
The region of the upper extremity in which the IV will be placed will be prepped with chlorhexidine and a proximal elastic tourniquet is applied to the upper arm. A 20 gauge 30 millimeter IV catheter is inserted into an upper extremity vein by an anesthesiologist in either an antegrade or retrograde direction depending on which treatment arm the study subject is randomized to.

Other: Blood draw
A 20 milliliter(mL) syringe will be connected to the study IV tubing and used to aspirate 20 mL of blood from the study IV catheter. If 20 mL are unable to be aspirated over a 2 minute time frame, a proximal rubber tourniquet will be applied to the upper arm and the blood draw will be reattempted.This will occur twice throughout the study.

Device: Peripheral intravenous catheter
A 20 gauge 30 millimeter long BD Insyte(TM) Autoguard(TM) angiocatheter will be used for peripheral intravenous catheter placement as described above.

Drug: To keep open (TKO) infusion of 0.9% normal saline
After placement of the peripheral intravenous catheter, 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.

Experimental: Retrograde Intravenous Catheter
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.
Procedure: Peripheral intravenous catheter placement
The region of the upper extremity in which the IV will be placed will be prepped with chlorhexidine and a proximal elastic tourniquet is applied to the upper arm. A 20 gauge 30 millimeter IV catheter is inserted into an upper extremity vein by an anesthesiologist in either an antegrade or retrograde direction depending on which treatment arm the study subject is randomized to.

Other: Blood draw
A 20 milliliter(mL) syringe will be connected to the study IV tubing and used to aspirate 20 mL of blood from the study IV catheter. If 20 mL are unable to be aspirated over a 2 minute time frame, a proximal rubber tourniquet will be applied to the upper arm and the blood draw will be reattempted.This will occur twice throughout the study.

Device: Peripheral intravenous catheter
A 20 gauge 30 millimeter long BD Insyte(TM) Autoguard(TM) angiocatheter will be used for peripheral intravenous catheter placement as described above.

Drug: To keep open (TKO) infusion of 0.9% normal saline
After placement of the peripheral intravenous catheter, 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 :
  1. Ability to aspirate blood samples without tourniquet 3 hours after IV insertion [ Time Frame: three 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 :
  1. Ability to aspirate blood samples without tourniquet at the end of surgery [ Time Frame: three 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.

  2. Ability to aspirate blood samples with tourniquet (if needed) 3 hours after IV insertion [ Time Frame: three 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.

  3. Ability to aspirate blood samples with tourniquet (if needed) at the end of surgery [ Time Frame: three 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.

  4. Body mass index (BMI) as a predictor of success rate of blood draws 3 hours after IV insertion. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533777


Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: Andrew Feider, M.D. University of Iowa

Additional Information:
Publications:
Raffa m, Greco M, Barbati A. Intravenous Retrograde Anesthesia. In: Alemanno F, Bosco M, Barbati A, eds. Anesthesia of the Upper Limb. Verlag, Italia: Springer; 2014 225-230.

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Responsible Party: Andrew Feider, assistant professor of anesthesia, University of Iowa
ClinicalTrials.gov Identifier: NCT03533777     History of Changes
Other Study ID Numbers: 201805706
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No