Arterial Line Clinical Trial
Official title:
The Usefulness of Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients by Less Experienced Trainees: a Randomized Controlled Trial
Verified date | March 2023 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of the study is to evaluate the effect of smart glasses (Head-mounted display Moverio BT-300 (Epson Inc., USA)) on the first-attempt success rate of radial artery cannulation in pediatric patients by less experienced trainees. This study hypothesizes that the use of smart glasses improves the hand-eye coordination and the first-attempt success rate of radial artery cannulation. This is a single-center, randomized, placebo-controlled study comparing the real-time ultrasound image through smart glasses (intervention group) or the ultrasound machine's monitor (control group) during the radial arterial cannulation in pediatric patients undergoing general anesthesia by less experienced trainees.
Status | Completed |
Enrollment | 122 |
Est. completion date | February 7, 2023 |
Est. primary completion date | February 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 7 Years |
Eligibility | Inclusion Criteria: - General anesthesia - Arterial cannulation for hemodynamic monitoring, 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 theradial artery |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Jin-Tae Kim | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Anantasit N, Cheeptinnakorntaworn P, Khositseth A, Lertbunrian R, Chantra M. Ultrasound Versus Traditional Palpation to Guide Radial Artery Cannulation in Critically Ill Children: A Randomized Trial. J Ultrasound Med. 2017 Dec;36(12):2495-2501. doi: 10.1002/jum.14291. Epub 2017 Jul 8. — View Citation
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Ishii S, Shime N, Shibasaki M, Sawa T. Ultrasound-guided radial artery catheterization in infants and small children. Pediatr Crit Care Med. 2013 Jun;14(5):471-3. doi: 10.1097/PCC.0b013e31828a8657. — View Citation
Kim EH, Lee JH, Song IK, Kim JT, Lee WJ, Kim HS. Posterior Tibial Artery as an Alternative to the Radial Artery for Arterial Cannulation Site in Small Children: A Randomized Controlled Study. Anesthesiology. 2017 Sep;127(3):423-431. doi: 10.1097/ALN.0000000000001774. — View Citation
Maruyama K, Watanabe E, Kin T, Saito K, Kumakiri A, Noguchi A, Nagane M, Shiokawa Y. Smart Glasses for Neurosurgical Navigation by Augmented Reality. Oper Neurosurg (Hagerstown). 2018 Nov 1;15(5):551-556. doi: 10.1093/ons/opx279. — View Citation
Song IK, Choi JY, Lee JH, Kim EH, Kim HJ, Kim HS, Kim JT. Short-axis/out-of-plane or long-axis/in-plane ultrasound-guided arterial cannulation in children: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):522-7. doi: 10.1097/EJA.0000000000000453. — View Citation
Ueda K, Puangsuvan S, Hove MA, Bayman EO. Ultrasound visual image-guided vs Doppler auditory-assisted radial artery cannulation in infants and small children by non-expert anaesthesiologists: a randomized prospective study. Br J Anaesth. 2013 Feb;110(2):281-6. doi: 10.1093/bja/aes383. Epub 2012 Nov 14. — View Citation
White L, Halpin A, Turner M, Wallace L. Ultrasound-guided radial artery cannulation in adult and paediatric populations: a systematic review and meta-analysis. Br J Anaesth. 2016 May;116(5):610-7. doi: 10.1093/bja/aew097. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | First attempt success rate | Success at the first skin puncture | During radial artery cannulation (up to 1 hour) | |
Secondary | Size of radial artery | Internal diameter of radial artery | During radial artery cannulation (up to 1 hour) | |
Secondary | depth of radial artery | depth of radial artery from the skin | During radial artery cannulation (up to 1 hour) | |
Secondary | Overall attempt | Number of attempt of radial artery cannulation | During radial artery cannulation (up to 1 hour) | |
Secondary | Ultrasound image time | From ultrasound probe application, to get radial artery image on the ultrasound screen | During radial artery cannulation (up to 1 hour) | |
Secondary | Arterial cannulation time | From needle puncture, to Arterial waveform | During radial artery cannulation (up to 1 hour) | |
Secondary | Overall Procedure time | From ultrasound probe application, to Arterial waveform | During radial artery cannulation (up to 1 hour) | |
Secondary | Overall success rate | Success within 2 skin puncture and within 10 minutes at the chosen radial artery | During radial artery cannulation (up to 1 hour) | |
Secondary | Malfunction of radial artery catheter | Malfunction of Invasive blood pressure monitoring, Sampling | After radial artery cannulation assessed during anesthesia (up to 24 hour) | |
Secondary | Complication rate | Hematoma, Distal ischemia, Spasm accessed by ultrasound | After radial artery cannulation assessed up to PACU, PICU stay (up to 24 hour) | |
Secondary | Operator's experience | The prior experience of the operator's in ultrasound-guided vascular cannulation (5-10 cannulations, 10-30 cannulations, 30-50 cannulations, 50-100 cannulations) | During radial artery cannulation (up to 1 hour) | |
Secondary | Operator's satisfaction | Operator's satisfaction, 5 scale (Worst, Poor, Acceptable, Good, Best) | During radial artery cannulation (up to 1 hour) |
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