Clinical trial NCT05513378: Ultrasound-guided Subclavian Vein Catheterisation With a Needle Guide
Official title: A Randomized Controlled Trial Comparing In-line Ultrasound Guided Subclavian Vein Catheterization With or Without Needle Guide.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complications; Catheter, Mechanical
Catheterization, Central Venous
Keywords: diagnostic imaging
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients in need of a central venous catheter .
* Clinical indication for the subclavian route which includes expected time of use \>5 days.
* Signed informed consent.

Exclusion Criteria:

* Patient is deemed unsuitable for cannulation of the subclavian vein, based on a pre-procedural US examination by the operator, or due to unacceptable patient risk in case of mechanical complication (e.g., severe respiratory failure).

Primary outcomes:
measure: Number of subclavian catheter insertions with >1 skin puncture
timeFrame: During the central venous catheterization, up to 3 hours after inclusion
Secondary outcomes:
measure: The frequency of mechanical complications
timeFrame: 24 hours after the completion of the central venous catheterization
measure: Needle visibility
timeFrame: During the central venous catheterization, up to 4 hours after inclusion
measure: Time to successful vessel puncture
timeFrame: During the central venous catheterization, up to 4 hours after inclusion
measure: The number of needle redirections
timeFrame: During the central venous catheterization, up to 4 hours after inclusion
measure: The number of failed catheterizations
timeFrame: During the central venous catheterization, up to 4 hours after inclusion
measure: Feasibility of the needle guide
timeFrame: Through the study period, anticipated 3 years
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Intensive and Perioperative Care. Skåne University Hospital. Lund
state: Skåne
Study officials:
affiliation: Region Skåne and Lund University
name: Thomas Kander, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: