There is no Focus on Any Specific ConditionNCT03533777

Antegrade Versus Retrograde IV for Blood Draws

A study testing Peripheral intravenous catheter placement, Blood draw and Peripheral intravenous catheter in people with There is no Focus on Any Specific Condition, run by University of Iowa at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: There is no Focus on Any Specific Condition
What is being tested?: Peripheral intravenous catheter placement, Blood draw and Peripheral intravenous catheter
Type of treatment: Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 230 participants
Where: 1 siteUnited States
Study dates: 22 Jun 2018to 19 Jun 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: There is no Focus on Any Specific Condition
Being tested: Peripheral intravenous catheter placement, Blood draw, Peripheral intravenous catheter, To keep open (TKO) infusion of 0.9% normal saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peripheral intravenous catheter placementProcedure or surgery
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 drawOther
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 catheterDevice
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 salineDrug
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.

Study groups in NCT03533777
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Peripheral intravenous catheter placement; Other: Blood draw; Device: Peripheral intravenous catheter; Drug: To keep open (TKO) infusion of 0.9% normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: three hours after IV insertion

Secondary outcomes (4)

Ability to aspirate blood samples without tourniquet at the end of surgery
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.
Measured: three to eight hours after IV insertion
Ability to aspirate blood samples with tourniquet (if needed) 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, 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.
Measured: three hours after IV insertion
Ability to aspirate blood samples with tourniquet (if needed) at the end of surgery
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.
Measured: 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.
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.
Measured: three hours after IV insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 201819 Jun 2019

First posted23 May 2018
Study start22 Jun 2018
Primary completion19 Jun 2019
Study completion19 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for There is no Focus on Any Specific ConditionStudies of the same condition, open and under way.
More trials run by University of IowaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03533777
Sponsor's protocol ID: 201805706
Status last verified: Jun 2019
First submitted: 25 Apr 2018
Last updated: 1 Jul 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 27941574
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.
PubMed 1395446
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.
PubMed 2926973
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.
PubMed 1563586
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.
PubMed 1443110
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.
PubMed 15866606
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.
PubMed 7022111
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.
PubMed 26640979
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.
PubMed 19377051
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.
PubMed 25525365
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 at a glance

From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Retrograde and Antegrade Peripheral Intravenous Cannulation on the Ability to Aspirate Blood Samples in the Operating Room
ClinicalTrials.gov ID: NCT03533777
Acronym / sponsor ID: 201805706
Conditions: There is no Focus on Any Specific Condition
Study type: Interventional
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: University of IowaUniversity, hospital or other
Study start: 22 Jun 2018 (actual)
Primary completion: 19 Jun 2019 (actual)
Study completion: 19 Jun 2019 (actual)
First posted: 23 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Antegrade Intravenous Catheter	Active comparator	Procedure: Peripheral intravenous catheter placement, Other: Blood draw, Device: Peripheral intravenous catheter, Drug: To keep open (TKO) infusion of 0.9% normal salineA 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.
Retrograde Intravenous Catheter	Experimental	Procedure: Peripheral intravenous catheter placement, Other: Blood draw, Device: Peripheral intravenous catheter, Drug: To keep open (TKO) infusion of 0.9% normal salineA 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.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peripheral intravenous catheter placementThe 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.	Procedure or surgery	Antegrade Intravenous Catheter, Retrograde Intravenous Catheter
Blood drawA 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.	Other	Antegrade Intravenous Catheter, Retrograde Intravenous Catheter
Peripheral intravenous catheterA 20 gauge 30 millimeter long BD Insyte(TM) Autoguard(TM) angiocatheter will be used for peripheral intravenous catheter placement as described above.	Device	Antegrade Intravenous Catheter, Retrograde Intravenous Catheter
To keep open (TKO) infusion of 0.9% normal salineAfter 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.	Drug	Antegrade Intravenous Catheter, Retrograde Intravenous Catheter

Primary outcome

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.

4 secondary outcomes

Ability to aspirate blood samples without tourniquet at the end of surgery
Time frame: 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
Ability to aspirate blood samples with tourniquet (if needed) at the end of surgery
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
Background: PubMed 27941574Abdelaal 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.
Background: PubMed 1395446Nauck 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.
Background: PubMed 2926973Brooks 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.
Background: PubMed 1563586Liu 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.
Background: PubMed 1443110Copeland 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.
Background: PubMed 15866606Diamond 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.
Background: PubMed 7022111Abumrad 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.
Background: PubMed 26640979Nuttall 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.
Background: PubMed 19377051Bhananker 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.
Background: PubMed 25525365Abolfotouh 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.
BackgroundRaffa 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Feider, M.D. principal investigator

University of Iowa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ability to aspirate blood samples without tourniquet 3 hours after IV insertion (time frame: three hours after IV insertion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03533777, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.