The aim of this pilot study is to evaluate the feasibility, safety and effectiveness of intrathecal pump refill procedures at home. It is our hypothesis that a refill at home will be safe, effectiveness and feasible, as is demonstrated in The Netherlands, and preferred by patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Implantable pump refill is performed at home
Universitair Ziekenhuis Brussel
Jette, Belgium
Patient satisfaction
A seven-point Likert scale asking the patient to rate the overall level of satisfaction with the refill at home will be used.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Successful pump refill
A binary variable to indicate success or failure of this intervention, reported by the physician.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Patient safety
A seven-point Likert scale asking the patient to rate the overall level of safety with the refill at home will be used.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Physician safety
A seven-point Likert scale asking the physician to rate the overall level of safety with the refill at home will be used.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Environmental safety
An open question in which the physician can indicate whether there were any situations that were not safe.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Clean, sterile procedure
An open question in which the physician can mention all potential risks.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
An objective confirmation of correct injection in the pump by ultrasound.
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After the refill procedure is performed, an ultrasound will be made to visually ensure that the refill was correctly performed without loss of liquor outside the pump.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Adverse events
All adverse events will systematically be reported by the physician.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Patient feasibility
A seven-point Likert scale asking the patient to rate the overall level of feasibility with the refill at home will be used.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Quality of teleconsultant connection by teleconsultant
Quality of the internet connection will be evaluated by the teleconsultant.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Time burden for teleconsultant
The time will be measured from the beginning until the end of the call.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Physician feasibility
A seven-point Likert scale asking the physician to rate the overall level of feasibility with the refill at home will be used.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Quality of teleconsultant connection by physician
Quality of the internet connection will be evaluated by the physician.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Time burden for physician
The time will be measured from the beginning until the end of the call.
Time frame: Once, at the moment of the study visit, immediately after the pump refill
Patient preference
Patients will be asked to indicate whether they prefer to have their next refill at home.
Time frame: Once, at the moment of the study visit, immediately after the pump refill