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Development and validation of a scale to predict the risk of failure on the first attempt of inserting an intravenous peripheral catheter


- candidate number17731
- NTR NumberNTR4595
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mei-2014
- Secondary IDsniet-WMO 2013-59 METC Catharina Ziekenhuis Eindhoven
- Public TitleDevelopment and validation of a scale to predict the risk of failure on the first attempt of inserting an intravenous peripheral catheter
- Scientific TitleA-DIVA study
- ACRONYMA-DIVA
- hypothesisThe primary objective of this study is to develop a difficult venous access score for adults (A-DIVA score) that predicts the risk of failure on the first attempt of inserting an IV peripheral catheter, based on easily available clinical data. We hypothesize that the A-DIVA score is a valuable clinical prediction rule that is simple and easy to use in daily practice.
- Healt Condition(s) or Problem(s) studiedPeripheral IV cannula (PIV) insertion
- Inclusion criteriaPatients 18 years or older were eligible when scheduled for an elective surgical procedure and included in the study in our preoperative holding area of the operation theatre.
- Exclusion criteriaPatients were excluded when they were not adequate to answer questions or when an IV access was requested from the ward.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2014
- planned closingdate31-dec-2014
- Target number of participants2500
- InterventionsIV access was routinely obtained in the preoperative holding area by nurse anesthetists (NA), who are experienced with inserting peripheral IV catheters and familiar with the study protocol. After consenting to the procedure, patientsí demographical, physical and historical information were recorded on for this study designed forms. A tourniquet was placed on an upper extremity.
Measurement of time needed for the procedure started when the NA started identifying the target vein visually and/or by palpation. Before cannulation, the skin was cleaned with chloorhexidine 70%. The NA performing the procedure defined the IV access successful, if blood returns in the catheter and/or when a saline flush could be injected without compromising the vein and signs of subcutaneous injection were absent. End time of the procedure was registered after securing the IV cannula in a successful attempt.
- Primary outcomeThe primary outcome variable was defined as failed peripheral IV catheterization on the first attempt. An attempt was defined as when the needle first touches the skin until the needle was removed from the skin. A new attempt was defined as any change in vessel localization, followed by a new skin puncture. For development of the A-DIVA score, following patientsí characteristics were collected: sex, age, weight, length, body mass index, skin shade, dominant site, tympanic temperature, whether or not the patient received premedication and if it was difficult to achieve and IV access in the past. These data were collected prior to the procedure, by asking the patient or from the preoperative anesthesia screening form. Procedure-related factors were registered prior to or after insertion of an IV catheter: skin shade, size of the cannula, side of the cannulation, place of cannulation on the extremity, size of the stewed vein in millimeters, pain score after every puncture on an eleven-points NRS scale (score 0 is no pain en score 10 is the worst imaginable pain), number of attempts needed for successful IV cannulation, whether or not the vein was palpable and/or visual before puncture (answered with yes or no) and the years of experience of the NA. After the procedure, patients historical and physical status were collected by asking the patient or from the preoperative anesthesia screening forms: sex, length, weight, BMI and special attention was paid to (chronic) diseases, IV drug abuse, vessel diseases, hematological status and the use of medications.
- Secondary outcome-
- TimepointsMeasurement of time needed for the procedure started when the NA started 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-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES F.H.J. Loon, van
- CONTACT for SCIENTIFIC QUERIES F.H.J. Loon, van
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications-
- Brief summary-
- Main changes (audit trail)
- RECORD13-mei-2014 - 10-jun-2014


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