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van CCT (UK)

van CCT (UK)

External validation and examination of performance of the modified A-DIVA II scale, a predictive scale to identify adult patients with a difficult intravenous access prospectively.

- candidate number24311
- NTR NumberNTR5846
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-mei-2016
- Secondary IDsniet-WMO 2015-21 MEC-U (Catharina Hospital Eindhoven)
- Public TitleExternal validation and examination of performance of the modified A-DIVA II scale, a predictive scale to identify adult patients with a difficult intravenous access prospectively.
- Scientific TitleA-DIVA II study
- hypothesisThe present study aimed to improve the performance of the A-DIVA scale by identifying predictors other than those included in the original scale. A modified A-DIVA II scale will be created which is applicable in the total hospitalized population to predict a difficult intravenous access in adult patients prospectively based on clinical observations.
- Healt Condition(s) or Problem(s) studiedCatheter
- Inclusion criteriaAll patients were adults, regardless their American Society of Anesthesiology (ASA) physical status, demographics, and medical history.
- Exclusion criteriaPatients were excluded if they did not understand or answer the questionnaire (due to physical or communicational disorders) or were unresponsive, when intravenous access had been gained already, and because of protocol violations.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2016
- planned closingdate1-jun-2017
- Target number of participants5000
- InterventionsPractitioners, both nurses and physicians from any specialism or medical department, who were familiar with the study protocol, routinely obtained the peripheral intravenous access. A peripheral intravenous catheter was inserted in the upper extremity, and veins on the dorsal and ventral surfaces of the upper extremity were considered for peripheral cannulation, including the metacarpal, cephalic, basilic, and median veins. Intravenous cannulation was performed according to practice guidelines. Before cannulation, a tourniquet was secured around the chosen arm, at least ten centimeters proximal to the elbow crease, and palpated and visualized to identify and acceptable vein. The tourniquet was tightened while maintaining pulsations of the radial artery. The puncture side was prepped with Chlorhexidine 70%. After each puncture, the practitioner checked whether the attempt was successful or not. The size of the inserted intravenous catheters ranged between 14 to 22 gauge, whereas the size of the catheter depended on the clinical situation.
- Primary outcomeThe primary outcome variable was defined as failed peripheral intravenous cannulation on the first attempt. Peripheral intravenous cannulation was defined successful, if the practitioner was able to inject a saline flush without signs of infiltration. We determined an attempt as one percutaneous needle puncture, regardless the amount of subcutaneous exploration from the single puncture site. After a failed attempt, a new attempt was stated to be any change in localizing a vein, followed by a new percutaneous puncture.
- Secondary outcomeBaseline demographic data (sex, ASA physical status, age, weight, length, body mass index, whether or not the patient fastened for at least six hours, weeks of gestation, and whether or not the patient was signed up for planned surgery) and patients medical history (chronic diseases, intravenous drug abuse, alcohol abuse, smoking, vessel diseases, a history of chemotherapy treatment, hematological status, the use of medications, and hypovolemia based on hemodialysis or dehydration) were provided by our local institutional clinical registry, which collects information in a computerized database. Procedure related data (patientís dominant side, received premedication, skin shade classified on a three-point scale based on race and origin, diameter of the vein measured in millimeters after applying a tourniquet, whether or not the vein could be identified by palpating and/ or visualizing the upper extremity, if it was difficult to achieve an intravenous access in the past, size of the intravenous catheter, side of cannulation, place of cannulation on the extremity, pain score after cannulation on an eleven-points NRS scale, number of attempts needed for successful intravenous cannulation, and the years of experience of the physician) were prospectively collected by the attending physician and registered on specific forms. Furthermore, the full medical records of the eligible patients were reviewed in order to determine risk factors for a difficult intravenous access. The risk score for a failed first attempt upon insertion of an intravenous catheter was calculated for each patient prior to the procedure with the A-DIVA scale.
- TimepointsMeasurement of time needed for the procedure started with identifying the target vein visually and/or by palpation. End time of the procedure was registered after securing the IV cannula in a successful attempt.
- Trial web site
- statusplanned
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsLoon FHJ van, Puijn LAPM, Houterman S, Bouwman ARA. Development of the A-DIVA Scale: A Clinical Predictive Scale to Identify Difficult Intravenous Access in Adult Patients Based on Clinical Observations. Medicine (Baltimore). 2016;95(16):e3428. doi:10.1097/MD.0000000000003428.
- Brief summary
- Main changes (audit trail)
- RECORD3-mei-2016 - 6-jul-2016

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