Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2018-06-22
2019-06-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
Yes
Sponsors
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University of Iowa
OTHER
Responsible Party
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Andrew Feider
assistant professor of anesthesia
Principal Investigators
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Andrew Feider, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Countries
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References
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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.
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.
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.
Related Links
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Understanding retrograde I.V. blood collection in clinical research.
Other Identifiers
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201805706
Identifier Type: -
Identifier Source: org_study_id
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