Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children
- Conditions
- Radial Artery Canulation
- Interventions
- Drug: NTG patchOther: gauze cover
- Registration Number
- NCT04002544
- Lead Sponsor
- Cairo University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- children aged between 2 and 5 years scheduled for cardiac surgery
- Systolic blood pressure less than 90 mmHg,
- previous radial artery puncture
- abnormal Allen's test
- hypercoagulable states
- coagulopathy
- previous vascular complications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NTG group NTG patch In this group, nitroglycerin patch will be applied near the radial artery pulsation covered with a gauze. Control group gauze cover In this group, no patch as applied to the patient. However, a gauze will be applied to confirm blinding NTG group gauze cover In this group, nitroglycerin patch will be applied near the radial artery pulsation covered with a gauze.
- Primary Outcome Measures
Name Time Method change in The diameter of radial artery 1 minutes before intervention then 30 and 60-minutes after the intervention mm
- Secondary Outcome Measures
Name Time Method palpability of radial pulse after NTG patch application 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
systolic blood pressure 1 minute before the intervention, every 5 minutes for 1 hour mmHg
postoperative ischemic complications 24 hours post intervention incidence
successful first-puncture cannulation 30 minutes incidence
Number of arterial punctures 30 minutes number
successful cannulation confirmed 30 minutes incidence
Trial Locations
- Locations (1)
Ahmed Mohamed Hasanin
🇪🇬Cairo, Egypt