OBJECTIVES The primary objective is to compare if the addition of a needle guide can reduce the number of central venous catheter (CVC) insertions with \>1 skin puncture in ultrasound-guided catheterization of the subclavian vein using the long-axis approach with an in-plane needling technique. Secondary objectives include if this addition 1) decreases the frequency of mechanical complications (defined as bleeding, arterial puncture, arterial catheterization, nerve injury, pneumothorax), 2) increases the time when the needle is visible, 3) decreases the time until successful vessel punction, 4) decreases the number of needle redirections during the insertion, and 5) a comparison between the two groups regarding number of failed catheterizations. DESIGN This is a prospective, randomised, controlled, parallel intervention study. Patients will be enrolled at Skåne University Hospital in Lund, Sweden. The trial is investigator-initiated and non-commercial. POPULATION AND INTERVENTION Adults (18 years of age or older) in need of a subclavian CVC for any reason and able to give written informed consent will be included in the study provided no exclusion criteria is fulfilled. OUTCOMES Primary outcome will be number of CVC insertions with \>1 skin puncture. Secondary outcomes include comparison between the two groups regarding 1) the frequency of mechanical complications, 2) proportion of the insertion-time when the needle is visible on the ultrasound (US) screen, 3) time to successful vessel punction, 4) the number of needle redirections during the insertion, 5) number of failed catheterisations, 6) Feasibility of the needle guide evaluated with a questionair to the operators at the end of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
300
Please see the arm/group description
Intensive and Perioperative Care. Skåne University Hospital. Lund
Lund, Skåne County, Sweden
Number of subclavian catheter insertions with >1 skin puncture
Number of subclavian catheter insertions with \>1 skin puncture
Time frame: During the central venous catheterization, up to 3 hours after inclusion
The frequency of mechanical complications
Mechanical complication include: 1) Bleeding World Health Organization (WHO)-grade 2-4. 2) Pneumothorax visible on post-procedural Xray. 3) Permanent nerve injury. 4) Arrhythmia WHO-grade 3 and 4. 5) Arterial catheterization
Time frame: 24 hours after the completion of the central venous catheterization
Needle visibility
Proportion of the insertion-time when the needle is visible on the ultrasound screen
Time frame: During the central venous catheterization, up to 4 hours after inclusion
Time to successful vessel puncture
Time to successful vessel puncture
Time frame: During the central venous catheterization, up to 4 hours after inclusion
The number of needle redirections
The number of needle redirections during the insertion
Time frame: During the central venous catheterization, up to 4 hours after inclusion
The number of failed catheterizations
The number of failed catheterizations in the attempted subclavian vein
Time frame: During the central venous catheterization, up to 4 hours after inclusion
Feasibility of the needle guide
Feasibility of the needle guide by means of a questionnaire at the end of the study period.
Time frame: Through the study period, anticipated 3 years
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