Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Radial Artery Canulation
• Intervention / Treatment: Drug: NTG patch; Other: gauze cover

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Ahmed Mohamed Hasanin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NTG group; In this group, nitroglycerin patch will be applied near the radial artery pulsation covered with a gauze.	Drug: NTG 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; Other: gauze cover; A gauze will be applied near the radial artery pulsation to ensure blinding
Placebo Comparator: Control group; In this group, no patch as applied to the patient. However, a gauze will be applied to confirm blinding	Other: gauze cover; A gauze will be applied near the radial artery pulsation to ensure blinding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in The diameter of radial artery	mm	1 minutes before intervention then 30 and 60-minutes after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
palpability of radial pulse after NTG patch application	Grade 0: palpability did not change after NTG, grade 1: palpability improved after NTG, grade 2: palpability became bounding after NTG	1 minutes before intervention then 30 and 60-minutes after the intervention
Number of arterial punctures	number	30 minutes
successful cannulation confirmed	incidence	30 minutes
successful first-puncture cannulation	incidence	30 minutes
postoperative ischemic complications	incidence	24 hours post intervention
systolic blood pressure	mmHg	1 minute before the intervention, every 5 minutes for 1 hour

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Ashraf Rady, Professor, Head of department of anesthesia, Cairo University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: S72019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No