Arterial Line, Ischemia
Conditions
Keywords
Radial Artery, Vascular Catheters
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.
Interventions
DRUGNitroglycerin
Subcutaneous nitroglycerin injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.
DRUGNormal saline
Subcutaneous normal saline injection to decrease the incidence of radial arterial occlusion after arterial catheter removal in pediatric patients.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 36 Months
Healthy volunteers
No
Inclusion criteria
* Patients undergoing General anesthesia * Patients in the Intensive care unit * Arterial cannulation for hemodynamic monitoring, or multiple blood sample
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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) |
| Overall success rate (%) | During radial artery cannulation (up to 1 hour) | Success within 2 skin puncture and within 10 minutes |
Countries
South Korea
Outcome results
None listed