Clinical trial NCT04002544: Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children
Official title: Topical Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Radial Artery Canulation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: change in The diameter of radial artery
timeFrame: 1 minutes before intervention then 30 and 60-minutes after the intervention
Secondary outcomes:
measure: palpability of radial pulse after NTG patch application
timeFrame: 1 minutes before intervention then 30 and 60-minutes after the intervention
measure: Number of arterial punctures
timeFrame: 30 minutes
measure: successful cannulation confirmed
timeFrame: 30 minutes
measure: successful first-puncture cannulation
timeFrame: 30 minutes
measure: postoperative ischemic complications
timeFrame: 24 hours post intervention
measure: systolic blood pressure
timeFrame: 1 minute before the intervention, every 5 minutes for 1 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mohamed Hasanin
Study officials:
affiliation: Head of department of anesthesia, Cairo University, Egypt
name: Ashraf Rady, Professor
role: STUDY_DIRECTOR
References: