Clinical trial NCT06469034: Head-mounted Display for Central Venous Catheterization
Official title: Use of Head-mounted Display for Ultrasound-guided Central Venous Catheterization in Adults: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Catheterization
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Head-mounted displays (HMD) in medical practice are current research topics. The goal of this clinical trial is to learn if HMD would improve the safety and efficacy in ultrasound-guided central venous catheterization. The main questions it aims to answer are: Does HMD reduce the procedure time and increase the catheterization success rate in ultrasound-guided central venous catheterization. Does HMD increase the satisfaction score of operators and patients. Researchers will compare HMD with the conventional ultrasound in central venous catheterization. Operators will receive either HMD or conventional ultrasound machine to guide internal jugular vein catheterization. The procedure time, puncture success rate, complication and satisfactory score will be recorded.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for elective surgery under general anesthesia
2. Patients indicative of internal jugular vein catheterization.

Exclusion Criteria:

1. A recent history of internal jugular vein puncture, wound, infection, hematomas, nerve injury at the venous cannulation site; 2. Combined with peripheral vascular disease, coagulopathy; 3. History of opiate abuse; 4. Pre-existing chronic pain, mental or neurological disorders; 5. Allergy to local anesthetics or gel; 6. Unstable vital signs, including hypertension, hypotension or arrhythmia

Primary outcomes:
measure: Total catheterization time
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
Secondary outcomes:
measure: Ultrasound scan time
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: Venous access time
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: Number of needle redirections
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: Number of looks at the monitor
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: Time spent looking at the patient
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: Time spent looking at the monitor
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: First-attempt success rate of internal jugular vein cannulation
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: The second attempt success rate
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: Number of attempts of needle puncture
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: The incidence and severity of complications
timeFrame: From application of the ultrasound probe to skin to the catheter removal
measure: pain score of procedure
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: Failure rate of catheterization.
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: Satisfaction score of patients
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: Satisfaction score of operators
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: The diameter and depth of the internal jugular vein
timeFrame: From application of the ultrasound probe to skin to the beginning of puncture
measure: Number of attempts of guidewire insertion
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: Number of probe repositioning
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
measure: The distance of tip of the needle from central line of vessel
timeFrame: From application of the ultrasound probe to skin to the end of catheterization
Other outcomes:
Locations:
city: Hefei
country: China
facility: Second Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Ye Zhang, MD, PhD
role: STUDY_CHAIR
References: