Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Radial Artery Canulation

Treatments: Drug: NTG patch; Other: gauze cover

Study type: Interventional

Funder types: Other

Identifiers

NCT04002544

S72019

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

NTG group

Active Comparator group

Description:

In this group, nitroglycerin patch will be applied near the radial artery pulsation covered with a gauze.

Treatment:

Other: gauze cover

Drug: NTG patch

Control group

Placebo Comparator group

Description:

In this group, no patch as applied to the patient. However, a gauze will be applied to confirm blinding

Treatment:

Other: gauze cover