- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03533777
Antegrade Versus Retrograde IV for Blood Draws
June 27, 2019 updated by: Andrew Feider, University of Iowa
Comparison of Retrograde and Antegrade Peripheral Intravenous Cannulation on the Ability to Aspirate Blood Samples in the Operating Room
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.
Study Overview
Status
Completed
Conditions
Detailed Description
- 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.
- 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.
- 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.
- 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.
- The IV will be saline locked at the end of the case.
- 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.
- 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.
- 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.
Study Type
Interventional
Enrollment (Actual)
230
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
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.
A 20 gauge 30 millimeter long BD Insyte(TM) Autoguard(TM) angiocatheter will be used for peripheral intravenous catheter placement as described above.
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.
|
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.
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.
A 20 gauge 30 millimeter long BD Insyte(TM) Autoguard(TM) angiocatheter will be used for peripheral intravenous catheter placement as described above.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
three hours after IV insertion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
three to eight hours after IV insertion
|
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.
|
three hours after IV insertion
|
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.
|
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.
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.
|
three hours after IV insertion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Feider, M.D., University of Iowa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2018
Primary Completion (Actual)
June 19, 2019
Study Completion (Actual)
June 19, 2019
Study Registration Dates
First Submitted
April 25, 2018
First Submitted That Met QC Criteria
May 10, 2018
First Posted (Actual)
May 23, 2018
Study Record Updates
Last Update Posted (Actual)
July 1, 2019
Last Update Submitted That Met QC Criteria
June 27, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 201805706
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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