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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05513378
Other study ID # ELUSIVE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 8, 2022
Est. completion date June 30, 2025

Study information

Verified date November 2023
Source Region Skane
Contact Thomas Kander, Assoc. Prof.
Phone +46 46 171163
Email thomas.kander@med.lu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 105 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Needle guide
Please see the arm/group description

Locations

Country Name City State
Sweden Intensive and Perioperative Care. Skåne University Hospital. Lund Lund Skåne

Sponsors (1)

Lead Sponsor Collaborator
Thomas Kander

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of subclavian catheter insertions with >1 skin puncture Number of subclavian catheter insertions with >1 skin puncture During the central venous catheterization, up to 3 hours after inclusion
Secondary 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 24 hours after the completion of the central venous catheterization
Secondary Needle visibility Proportion of the insertion-time when the needle is visible on the ultrasound screen During the central venous catheterization, up to 4 hours after inclusion
Secondary Time to successful vessel puncture Time to successful vessel puncture During the central venous catheterization, up to 4 hours after inclusion
Secondary The number of needle redirections The number of needle redirections during the insertion During the central venous catheterization, up to 4 hours after inclusion
Secondary The number of failed catheterizations The number of failed catheterizations in the attempted subclavian vein During the central venous catheterization, up to 4 hours after inclusion
Secondary Feasibility of the needle guide Feasibility of the needle guide by means of a questionnaire at the end of the study period. Through the study period, anticipated 3 years
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