Catheterization, Central Venous, Complications; Catheter, Mechanical
Conditions
Keywords
diagnostic imaging
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.
Interventions
DEVICENeedle guide
Please see the arm/group description
Sponsors
Thomas Kander
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The researcher who will review the documented ultrasound movies and assess the secondary outcomes will be blinded. However, given the nature of the study neither the Care Provider or Investigators will be blinded for the group affiliation or the primary outcome
Eligibility
Sex/Gender
ALL
Age
18 Years to 105 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subclavian catheter insertions with >1 skin puncture | During the central venous catheterization, up to 3 hours after inclusion | Number of subclavian catheter insertions with \>1 skin puncture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The frequency of mechanical complications | 24 hours after the completion of the central venous catheterization | 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 |
| Needle visibility | During the central venous catheterization, up to 4 hours after inclusion | Proportion of the insertion-time when the needle is visible on the ultrasound screen |
| The number of needle redirections | During the central venous catheterization, up to 4 hours after inclusion | The number of needle redirections during the insertion |
| The number of failed catheterizations | During the central venous catheterization, up to 4 hours after inclusion | The number of failed catheterizations in the attempted subclavian vein |
| Feasibility of the needle guide | Through the study period, anticipated 3 years | Feasibility of the needle guide by means of a questionnaire at the end of the study period. |
| Time to successful vessel puncture | During the central venous catheterization, up to 4 hours after inclusion | Time to successful vessel puncture |
Countries
Sweden
Outcome results
None listed