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Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04002544
Enrollment
40
Registered
2019-06-28
Start date
2019-09-15
Completion date
2019-11-30
Last updated
2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radial Artery Canulation

Brief summary

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.

Detailed description

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

Interventions

DRUGNTG patch

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

OTHERgauze cover

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in The diameter of radial artery1 minutes before intervention then 30 and 60-minutes after the interventionmm

Secondary

MeasureTime frameDescription
palpability of radial pulse after NTG patch application1 minutes before intervention then 30 and 60-minutes after the interventionGrade 0: palpability did not change after NTG, grade 1: palpability improved after NTG, grade 2: palpability became bounding after NTG
Number of arterial punctures30 minutesnumber
successful first-puncture cannulation30 minutesincidence
postoperative ischemic complications24 hours post interventionincidence
systolic blood pressure1 minute before the intervention, every 5 minutes for 1 hourmmHg
successful cannulation confirmed30 minutesincidence

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026