Primary Objective: Investigate whether fixation of the ultrasound probe, thereby freeing both hands for needling, improves performance of radial artery punctureSecondary Objective(s): Investigate whether fixation of the probe will lead to decreased…
ID
Source
Brief title
Condition
- Other condition
- Vascular therapeutic procedures
Synonym
Health condition
diagnostiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint will be the rate of successful first attempt for
catheterization. An attempt is defined as a straight advancement of the needle
until positioned in the artery. If the needle is withdrawn 5 mm or more and
advanced again, this counts as a new attempt.
Secondary outcome
Secondary endpoints will be total time for completion of the procedure, for the
digital palpation group this is the time from first palpation of the artery
till placement of the catheter. In the US groups, this is the time from first
contact of the US transducer with the subject*s skin until placement of the
catheter.
Other recorded parameters will be total attempts needed to complete the
procedure, total attempts per group, skin punctures, failures
Background summary
Arterial cannulation for continuous invasive blood pressure monitoring and
blood sampling is a standard procedure for patients undergoing cardiothoracic
surgery. Traditionally performed by digital palpation, ultrasound (US) is
increasingly used for this procedure. However, US guidance marginally increases
success rates for this procedure. A possible explanation is unintentional
movement of the US probe during manipulation of the needle when targeting the
artery. We hypothesize that by fixating the probe during puncture, by
eliminating inadvertent displacement of the probe the US image will be more
steady, thereby improving performance of the cannulation procedure.
Study objective
Primary Objective: Investigate whether fixation of the ultrasound probe,
thereby freeing both hands for needling, improves performance of radial artery
puncture
Secondary Objective(s): Investigate whether fixation of the probe will lead to
decreased occurrence of (local) complications, e.g. hematoma
Study design
The study will be a prospective, randomized, non-blinded trial
Intervention
fixation of the ultrasound probe during radial artery catheterization
Study burden and risks
Arterial cannulation is a standard procedure for cardiothoracic surgery, no
additional invasive procedures will be performed. Serious complications of this
technique are rare, but local hematoma does occur. From our own experience, we
expect the new technique to cause less tissue trauma and hematoma.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
written informed consent
elective major abdominal or cardiothoracic surgery
Exclusion criteria
No informed consent
Emergency procedures
Pre-existing injury at the radial artery cannulation site (hematoma, infection, surgery e.g. radial artery harvesting)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56971.100.16 |