AzTrials
AzTrials

Arterial LineNCT03849183

Subcutaneous Nitroglycerin for Pediatric Radial Artery Cannulation

A study testing Nitroglycerin and Normal saline in people with Arterial Line, run by Seoul National University Hospital at 1 site in South Korea.

Completed

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

Official record
Search all trials

Trial summary

The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin during ultrasound-guided radial artery cannulation in pediatric patients. The hypothesis of this study is that the subcutaneous nitroglycerin will increase the radial artery size and improve the first-attempt… Read more about this study

Who is it for?
Ages Up to 2 years
Conditions the study is for
Arterial Line
What is being tested?
Nitroglycerin and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteSouth Korea
Study dates
20 Mar 2019to 22 Jul 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 Up to 2 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • General anesthesia
  • Arterial cannulation for hemodynamic monitoring, multiple blood sample

Who cannot join

  • Hypersensitivity or contraindication to nitroglycerine
  • Unstable vital sign, significant arrhythmia or hypotension, Shock
  • High risk of peripheral ischemia
  • Skin disease, infection, hematoma, recent cannulation at radial artery.
  • Increased intracranial pressure, Intracranial hemorrhage
  • Glaucoma
  • Recent use of PDE5 inhibitors (<24 hours after sildenafil or vardenafil; <48 hours after tadalafil)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Jin-Tae Kim

    Seoul

Other trials in South Korea

About this study

Official title: The Effect of Subcutaneous Nitroglycerin on the Success Rate of Arterial Catheterization in Pediatric Patients: a Randomized Controlled Trial

The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin during ultrasound-guided radial artery cannulation in pediatric patients. The hypothesis of this study is that the subcutaneous nitroglycerin will increase the radial artery size and improve the first-attempt success rate of radial artery cannulation. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of subcutaneous nitroglycerin and saline on radial artery cannulation in pediatric patients undergoing general anesthesia. Prior to the procedure, each patient will be randomized into either the control arm, saline, or study arm, nitroglycerin.

Conditions
Arterial Line
Being tested
Nitroglycerin, Normal saline
Keywords
Radial Artery, Vascular Catheters

What participants receive

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

  • NitroglycerinDrug

    Also called Subcutaneous Nitroglycerin

    Subcutaneous nitroglycerin injection to increase the first attempt success rate of radial artery cannulation in pediatric patients

  • Normal salineDrug

    Also called Subcutaneous Normal saline

    Subcutaneous normal saline injection to increase the first attempt success rate of radial artery cannulation in pediatric patients

Study groups in NCT03849183
Study groupRoleWhat they receive
NitroglycerinExperimentalNitroglycerin 5mcg/kg (0.5cc) is subcutaneously injected before radial artery cannulation.
Receives: Drug: Nitroglycerin
ControlActive comparatorNormal saline (0.5cc) is subcutaneously injected before radial artery cannulation.
Receives: Drug: Normal saline

What is being measured

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

  1. First attempt success rate

    Success at the first skin puncture

    Measured: During radial artery cannulation (up to 1 hour)

Secondary outcomes (7)

  1. Size of radial artery

    Internal diameter of radial artery

    Measured: Before and after subcutaneous injection of drugs (up to 1 hour)

  2. depth of radial artery

    depth of radial artery from the skin

    Measured: Before and after subcutaneous injection of drugs (up to 1 hour)

  3. Overall attempt

    Number of attempt of radial artery cannulation

    Measured: During radial artery cannulation (up to 1 hour)

  4. Overall Procedure time

    From ultrasound guidance, to Arterial waveform

    Measured: During radial artery cannulation (up to 1 hour)

  5. Overall success rate

    Success within 4 skin puncture (2 skin puncture at each radial artery)

    Measured: During radial artery cannulation (up to 1 hour)

  6. Malfunction of radial artery catheter

    Invasive blood pressure monitoring, Sampling

    Measured: After radial artery cannulation assessed during anesthesia (up to 24 hour)

  7. Complication rate

    Hematoma, Distal ischemia, Spasm accessed by ultrasound

    Measured: After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour)

Timeline

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

  1. First posted21 Feb 2019
  2. Study start20 Mar 2019
  3. Primary completion22 Jul 2019
  4. Study completion22 Jul 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03849183
Sponsor's protocol ID
H-1810-077-979
Status last verified
Nov 2019
First submitted
18 Feb 2019
Last updated
6 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chong AY, Lo T, George S, Ratib K, Mamas M, Nolan J. The effect of pre-procedure sublingual nitroglycerin on radial artery diameter and Allen's test outcome - Relevance to transradial catheterization. Cardiovasc Revasc Med. 2018 Mar;19(2):163-167. doi: 10.1016/j.carrev.2017.07.016. Epub 2017 Jul 29.

    PubMed 28923695

  • Chen Y, Ke Z, Xiao J, Lin M, Huang X, Yan C, Ye S, Tan X. Subcutaneous Injection of Nitroglycerin at the Radial Artery Puncture Site Reduces the Risk of Early Radial Artery Occlusion After Transradial Coronary Catheterization: A Randomized, Placebo-Controlled Clinical Trial. Circ Cardiovasc Interv. 2018 Jul;11(7):e006571. doi: 10.1161/CIRCINTERVENTIONS.118.006571.

    PubMed 30002088

  • Kim EH, Lee JH, Song IK, Kim JT, Lee WJ, Kim HS. Posterior Tibial Artery as an Alternative to the Radial Artery for Arterial Cannulation Site in Small Children: A Randomized Controlled Study. Anesthesiology. 2017 Sep;127(3):423-431. doi: 10.1097/ALN.0000000000001774.

    PubMed 28682811

  • Ezhumalai B, Satheesh S, Jayaraman B. Effects of subcutaneously infiltrated nitroglycerin on diameter, palpability, ease-of-puncture and pre-cannulation spasm of radial artery during transradial coronary angiography. Indian Heart J. 2014 Nov-Dec;66(6):593-7. doi: 10.1016/j.ihj.2014.05.023. Epub 2014 Jun 7.

    PubMed 25634390

  • Beyer AT, Ng R, Singh A, Zimmet J, Shunk K, Yeghiazarians Y, Ports TA, Boyle AJ. Topical nitroglycerin and lidocaine to dilate the radial artery prior to transradial cardiac catheterization: a randomized, placebo-controlled, double-blind clinical trial: the PRE-DILATE Study. Int J Cardiol. 2013 Oct 3;168(3):2575-8. doi: 10.1016/j.ijcard.2013.03.048. Epub 2013 Apr 10.

    PubMed 23582415

  • Majure DT, Hallaux M, Yeghiazarians Y, Boyle AJ. Topical nitroglycerin and lidocaine locally vasodilate the radial artery without affecting systemic blood pressure: a dose-finding phase I study. J Crit Care. 2012 Oct;27(5):532.e9-13. doi: 10.1016/j.jcrc.2012.04.019. Epub 2012 Jun 12.

    PubMed 22699036

Questions about this trial

What is this clinical trial studying?

A study testing Nitroglycerin and Normal saline in people with Arterial Line, run by Seoul National University Hospital at 1 site in South Korea.

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 2 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 6 Nov 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 South Korea. 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?

First attempt success rate (time frame: During radial artery cannulation (up to 1 hour)). 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 NCT03849183, which also lists 6 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 6 Nov 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in