Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients
Recruitment status was Not yet recruiting
The puncture of the vascular access in hemodialysis patients remains challenging even in the hands of experienced dialysis nurses. Unsuccessful punctures are associated with resource wastage, traumatism of the AV shunts, shortening of the effective dialysis time and poor patient satisfaction.
The use of ultrasound by emergency department nurses and technicians without prior ultrasound experience in patients with difficult intravenous access showed in several studies to be very efficient. The investigators expect to achieve similar results in cannulation of AV shunts by the dialysis nurse staff after a short learning program.
To show this, the investigators aim to conduct a trail where standard cannulation technique (inspection, palpation) will be compared with the ultrasound-assisted method in terms of efficacy, safety and patient satisfaction.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Ultrasound Assisted Puncture of AV Fistulas in Chronic Hemodialysis Patients After a Short Learning Program in Bed-side Ultrasound for Hemodialysis Nurses by an Index Nurse - an Outcome Study|
- Rate of successful cannulations of an AV-fistula [ Time Frame: Immediately after the cannulation, expected to be after 10 minutes on average ] [ Designated as safety issue: No ]Satisfactory puncture of the fistula defined as the ability to achieve a full length dialysis (max. 10% reduction of the usual dialysis time), double-needle, and the usual blood flow rate (max. 15% reduction of the usual blood flow)
- Effective dialysis time [ Time Frame: Directly after the treatment, expected to be after 3 to 4.5 hours ] [ Designated as safety issue: No ]Measured in minutes
- Processed volume [ Time Frame: Directly after the treatment, expected to be after 3 to 4.5 hours ] [ Designated as safety issue: No ]
- Number of patients with late complications [ Time Frame: At the following dialysis session, expected to be after 2-3 days ] [ Designated as safety issue: Yes ]
- Patient satisfaction [ Time Frame: Immediately after the canulation, expected to be after 10 minutes on average, and at the following dialysis session, expected to be after 2-3 days ] [ Designated as safety issue: No ]Measured by questionnaire
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Ultrasound-assisted puncture
Ultrasound-assisted puncture by the nursing staff of patients with difficult AV-shunts.
Device: Ultrasound-assisted puncture
Portable ultrasound device
Classical method wtih inspection and palpation
Standard inspection, palpation.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02085486
|Contact: Robert M Kalicki, MDfirstname.lastname@example.org|
|Universitätsklinik für Nephrologie, Hypertonie und Klinische Pharmakologie, Inselspital Bern||Not yet recruiting|
|Bern, Switzerland, 3010|
|Contact: Robert M Kalicki, MD +41316323144 email@example.com|
|Principal Investigator: Robert M Kalicki, MD|
|Principal Investigator:||Robert M Kalicki, MD||Universitätsklinik für Nephrologie, Hypertonie und Klinische Pharmakologie, Inselspital Bern|