Skip to main content
OpenTrials
Completed

NCT Number: NCT04002544

Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children

Local nitroglycerin (NTG) was successfully used as a vasodilator to facilitate cannulation of the radial artery. NTG was used in adults by topical application as well as subcutaneous infiltration. Subcutaneous infiltration of NTG resulted in significant vasodilatation, improved palpability of the radial artery, reduced the number of punctures and the time needed for cannulation in adults. Topical NTG was reported to increase radial artery diameter in healthy volunteers without reduction in arterial blood pressure. In pediatric population, there no sufficient evidence for the effectiveness of NTG in improving radial artery cannulation. In a case report on two neonates, topical nitroderm ointment successfully reversed tissue ischemia secondary to radial artery cannulation The aim of this work is to evaluate the use of topical NTG (patch) for increasing the diameter of radial artery, improving the cannulation success, and decreasing catheter-related ischemic complications.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radial Artery Canulation

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

About this study

A written informed consent will be obtained from patient's parents or guardians. Randomization will be obtained using computer-generated sequence. Concealment will be obtained using opaque envelopes.

On arrival to the preparing room, patients will be randomized into one of the two groups:

  • NTG group or, Control group

Ultrasound examination:

The diameter of radial artery will be measured using a linear, high frequency probe (12 mHz) of Simens machine. Measurement will be obtained in the short axis plane at the point with maximal pulsation. The point will be marked to guide the post-intervention examination. The operator will be an experienced single operator blinded to the study group. Measurements will be obtained in both limbs at baseline (before application of NTG patch application,30 minutes,60minutes after NTG application After induction of anesthesia, radial artery will be punctured by 22-g catheter by an experienced anesthetist

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children aged between 2 and 5 years scheduled for cardiac surgery

Exclusion criteria

  • Systolic blood pressure less than 90 mmHg,
  • previous radial artery puncture
  • abnormal Allen's test
  • hypercoagulable states
  • coagulopathy
  • previous vascular complications

Treatment and study plan

NTG patch

Drug

A half-NTG patch (dose calculated at 5-12.5 mcg/kg/hr) will be applied to patients at the site of radial pulsation one hour before induction of anesthesia. The NTG patch will be applied to the right upper in half of the patients and will be applied to the left upper limb in the other half

gauze cover

Other

A gauze will be applied near the radial artery pulsation to ensure blinding

Primary outcomes

  1. change in The diameter of radial artery

    Time frame: 1 minutes before intervention then 30 and 60-minutes after the intervention

    mm

Secondary outcomes

  1. palpability of radial pulse after NTG patch application

    Time frame: 1 minutes before intervention then 30 and 60-minutes after the intervention

    Grade 0: palpability did not change after NTG, grade 1: palpability improved after NTG, grade 2: palpability became bounding after NTG

  2. Number of arterial punctures

    Time frame: 30 minutes

    number

  3. successful cannulation confirmed

    Time frame: 30 minutes

    incidence

  4. successful first-puncture cannulation

    Time frame: 30 minutes

    incidence

  5. postoperative ischemic complications

    Time frame: 24 hours post intervention

    incidence

  6. systolic blood pressure

    Time frame: 1 minute before the intervention, every 5 minutes for 1 hour

    mmHg

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Topical Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children: a Randomized Controlled Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2019
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.