To describe the differences in safety, patient comfort and admission period after diagnostic cardiac catheterization through radial access, between the current protocol and the protocol of fast desufflation by Carrington et al.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bleeding, defined as arterial (pulsatile) high velocity flow from the puncture
site
Secondary outcome
Oozing from the puncture site, defined as non-pulsatile.low velocity blood flow
Occlusion of the radial artery
Swelling at the puncture site
Patient comfort, measured on the visual-analog scale (VAS)
Time between return on the short-stay unit and discharge, in minutes
Incidence of cross-over from study group to control group.
Background summary
To obtain arterial access for a diagnostic cardiac catheterization or
percuteneous coronairy intervention (PCI) the cardiologist can choose between
the arteria femoralis and the arteria radialis. In the University Medical
Center Groningen the arteria femoralis is commonly used. After intervention the
puncture site is closed with an arteriotomy closure device (ACD). Patients
after radial access receive a pressure bandage at the puncture site, usually
the Terumo (TR) wrist bandage.
The bedrest period for patients with an ACD is 1 hour after diagnostic cardiac
catheterization and 2 hours after PCI. After the bedrest period patients are
discharged 1 hour after diagnostic procedures or 4 hours after PCI. This to
observe potential bleeding complications after the procedure.
In patients with radial access, the TR bandage will be removed according to
current protocol after 4 hours and additionally 1 hour observation is required.
Serveral cardiologists have the intention to use the arteria radialis more
frequent for cardiac catheterization or PCI. In a meta-analasys radial access
is related to a 73% decrease in major bleeding complications compared to
femoral access. Also there are no significant differences in MACE. Evenso there
are no differences in succes percentage for cardiac cathetrization or PCI and
admission time is shorter for radial access (Am Heart J. 2009
Jan;157(1):132-40).
Admission time for diagnostic cardiac catheterization at the short-stay unit is
in case of femoral access with an ACD approximately 2 hours. For patients after
radial access post procedural admission time is approximately 5 hours. To
guarantee patient throughput, uniformity of care and more efficient use of
capacity of the short-stay unit, patients after radial access should not have a
longer hospital admission time than patients after femoral access. Carrington
et al. (J Interv Cardiol. 2009 Dec;22(6):571-5) have shown that it is safe to
deflate the TR wrist band faster than four hours.
Study objective
To describe the differences in safety, patient comfort and admission period
after diagnostic cardiac catheterization through radial access, between the
current protocol and the protocol of fast desufflation by Carrington et al.
Study design
Single-center prospective randomised cohort study.
Intervention
Two groups:
Control group receives standard care:
- TR band fully inflated for two hours
- at two hours, deflate with 2 mls
- at three hours, deflate with 2 mls
- at fours hours, fully deflate in one minute
Experimental group:
- TR band fully inflated for one hour
- at one hour, start deflating with 2 mls every ten minutes until complete
deflation, which should be obtained within 60-70 minutes.
Both groups remain one hour at the unit for observation of the wrist.
Study burden and risks
This study does not lead to extra burden for the patient. The risk is limited
to bleeding at the puncture site. This will be observed directly and treated
immediately by inflating the wrist band until bleeding ceases. This leads to a
prolonged period of radial compression time, but it should be noticed that this
risk is also present for patients in the control group.
In case of repeated bleeding (at two consecutive attempts to lower the pressure
in the TR band) patients will cross-over to the control group.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Diagnostic cardiac catheterization through radial artery, patients admitted to short stay unit
Exclusion criteria
INR>2.0; percutaneous coronary intervention (PCI); cross-over to femoral artery; bleeding disorder
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 | NL38454.042.11 |