Antegrade Versus Retrograde IV for Blood Draws

NCT03533777 | Completed

• 1 other identifier: 201805706
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

There is no Focus on Any Specific Condition

Outcome Measures

Primary Outcomes (1)

• Ability to aspirate blood samples without tourniquet 3 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.

  three hours after IV insertion

Secondary Outcomes (4)

• Ability to aspirate blood samples without tourniquet at the end of surgery

  three to eight hours after IV insertion

• Ability to aspirate blood samples with tourniquet (if needed) 3 hours after IV insertion

  three hours after IV insertion

• Ability to aspirate blood samples with tourniquet (if needed) at the end of surgery

  three to eight hours after IV insertion

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

  three hours after IV insertion

Study Arms (2)

Antegrade Intravenous Catheter

ACTIVE COMPARATOR

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

Retrograde Intravenous Catheter

EXPERIMENTAL

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

Interventions

Peripheral intravenous catheter placement PROCEDURE

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.

Antegrade Intravenous Catheter; Retrograde Intravenous Catheter

Blood draw OTHER

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.

Antegrade Intravenous Catheter; Retrograde Intravenous Catheter

Peripheral intravenous catheter DEVICE

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

Antegrade Intravenous Catheter; Retrograde Intravenous Catheter

To keep open (TKO) infusion of 0.9% normal saline DRUG

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.

Antegrade Intravenous Catheter; Retrograde Intravenous Catheter

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (11)

• Abdelaal Ahmed Mahmoud A, El-Shafei HI, Yassin HM, Elramely MA, Abdelhaq MM, El Kady HW, Awada WNF. Comparison Between Retrograde and Antegrade Peripheral Venous Cannulation in Intensive Care Unit Patients: Assessment of Thrombus Formation. Anesth Analg. 2017 Jun;124(6):1839-1845. doi: 10.1213/ANE.0000000000001703.

  PMID: 27941574 BACKGROUND

• Nauck MA, Liess H, Siegel EG, Niedmann PD, Creutzfeldt W. Critical evaluation of the 'heated-hand-technique' for obtaining 'arterialized' venous blood: incomplete arterialization and alterations in glucagon responses. Clin Physiol. 1992 Sep;12(5):537-52. doi: 10.1111/j.1475-097x.1992.tb00357.x.

  PMID: 1395446 BACKGROUND

• Brooks DC, Black PR, Arcangeli MA, Aoki TT, Wilmore DW. The heated dorsal hand vein: an alternative arterial sampling site. JPEN J Parenter Enteral Nutr. 1989 Jan-Feb;13(1):102-5. doi: 10.1177/0148607189013001102.

  PMID: 2926973 BACKGROUND

• Liu D, Moberg E, Kollind M, Lins PE, Adamson U, Macdonald IA. Arterial, arterialized venous, venous and capillary blood glucose measurements in normal man during hyperinsulinaemic euglycaemia and hypoglycaemia. Diabetologia. 1992 Mar;35(3):287-90. doi: 10.1007/BF00400932.

  PMID: 1563586 BACKGROUND

• Copeland KC, Kenney FA, Nair KS. Heated dorsal hand vein sampling for metabolic studies: a reappraisal. Am J Physiol. 1992 Nov;263(5):E1010-4. doi: 10.1152/ajpendo.1992.263.5.E1010.

  PMID: 1443110 BACKGROUND

• Diamond MP, Kruger M, Collins K, Brossoit M, Subramanian M. Antecubital vein venous sampling does not distort circulating levels of peptide and sex steroid hormones. Fertil Steril. 2005 May;83(5):1557-60. doi: 10.1016/j.fertnstert.2005.01.001.

  PMID: 15866606 BACKGROUND

• Abumrad NN, Rabin D, Diamond MP, Lacy WW. Use of a heated superficial hand vein as an alternative site for the measurement of amino acid concentrations and for the study of glucose and alanine kinetics in man. Metabolism. 1981 Sep;30(9):936-40. doi: 10.1016/0026-0495(81)90074-3. No abstract available.

  PMID: 7022111 BACKGROUND

• Nuttall G, Burckhardt J, Hadley A, Kane S, Kor D, Marienau MS, Schroeder DR, Handlogten K, Wilson G, Oliver WC. Surgical and Patient Risk Factors for Severe Arterial Line Complications in Adults. Anesthesiology. 2016 Mar;124(3):590-7. doi: 10.1097/ALN.0000000000000967.

  PMID: 26640979 BACKGROUND

• Bhananker SM, Liau DW, Kooner PK, Posner KL, Caplan RA, Domino KB. Liability related to peripheral venous and arterial catheterization: a closed claims analysis. Anesth Analg. 2009 Jul;109(1):124-9. doi: 10.1213/ane.0b013e31818f87c8. Epub 2009 Apr 17.

  PMID: 19377051 BACKGROUND

• Abolfotouh MA, Salam M, Bani-Mustafa A, White D, Balkhy HH. Prospective study of incidence and predictors of peripheral intravenous catheter-induced complications. Ther Clin Risk Manag. 2014 Dec 8;10:993-1001. doi: 10.2147/TCRM.S74685. eCollection 2014.

  PMID: 25525365 BACKGROUND

• 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.

  BACKGROUND

Related Links

• Understanding retrograde I.V. blood collection in clinical research.

MeSH Terms

Interventions

Blood Specimen Collection; Saline Solution

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Andrew Feider, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 23, 2018
• Study Start: June 22, 2018
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: July 1, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)