Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children
- Conditions
- IschemiaArterial Line
- Interventions
- Drug: Normal saline
- Registration Number
- NCT05443061
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin to prevent radial arterial occlusion(RAO) after removal of the radial arterial catheter in pediatric patients. The hypothesis of this study is that subcutaneous nitroglycerin will decrease the incidence of radial arterial occlusion after radial arterial catheter removal in pediatric patients by increasing the radial artery size. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of subcutaneous nitroglycerin and saline on radial artery cannulation and catheter removal in pediatric patients. Prior to the procedure, each patient will be randomized into either the control arm, saline, or the study arm, nitroglycerin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Patients undergoing General anesthesia
- Patients in the Intensive care unit
- Arterial cannulation for hemodynamic monitoring, or multiple blood sample
- Unstable vital signs, significant arrhythmia or hypotension, Shock
- High risk of peripheral ischemia
- Skin disease, infection, hematoma, recent cannulation at the radial artery
- History of anaphylaxis to nitroglycerin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Normal saline Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter. Nitroglycerin Nitroglycerin Nitroglycerin 5mcg/kg (in 0.5cc) is subcutaneously injected before radial artery cannulation and before removal of the radial arterial catheter.
- Primary Outcome Measures
Name Time Method The incidence of radial arterial occlusion (RAO) (%) After removal of the radial artery catheter (up to 24 hour) RAO is defined as no pulse oximeter wave at the index finger during compression of the ipsilateral ulnar artery.
- Secondary Outcome Measures
Name Time Method Malfunction of radial artery catheter After radial artery cannulation assessed during anesthesia (per 24hour, up to 480 hour) Invasive blood pressure monitoring, Sampling (%)
Complication rate After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 480 hour) Hematoma, Distal ischemia, Spasm accessed by ultrasound (%)
Duration of radial arterial catherization After radial artery cannulation assessed during anesthesia (up to 480 hour) Duration of radial arterial catherization (hours, minutes)
First attempt success rate (%) During radial artery cannulation (up to 1 hour) Success at the first skin puncture
Incidence of posterior wall puncture (%) During radial artery cannulation (up to 1 hour) Incidence of posterior wall (transfixation technique) puncture during radial arterial catherization
Number of arteries cannulated During radial artery cannulation (up to 1 hour) Number of arteries cannulated for peripheral arterial catheterization
Perfusion index Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour) Perfusion index measured by pulse oximeter sensor at the distally located index finger of radial arterial catheterization
Overall attempt (number) During radial artery cannulation (up to 1 hour) Number of attempt of radial artery cannulation
Overall Procedure time (seconds) During radial artery cannulation (up to 1 hour) From ultrasound guidance, to Arterial waveform
Size of radial artery (mm) Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour) Internal diameter of radial artery
depth of radial artery (mm) Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour) depth of radial artery from the skin
flow velocity of the radial artery (cm/s) Before and after subcutaneous injection of drugs / Before and after catheterization / Before and after removal of the catheter (up to 1 hour) flow velocity of the radial artery measured by Doppler ultrasound
Overall success rate (%) During radial artery cannulation (up to 1 hour) Success within 2 skin puncture and within 10 minutes
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of