Simulation-Based Intrathecal Pump Refill Training
ConditionIntrathecal Drug Delivery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel
About this trial
Intrathecal drug delivery is an effective treatment option for patients with chronic (non-) cancer pain or spasticity who do not achieve sufficient benefit from conventional therapies. After intrathecal pump implantation, intrathecal pump refilling is an essential postoperative maintenance procedure that requires procedural competence to be performed safely and consistently. Despite the absence of a standardized intrathecal pump refill protocol, the REFFIL-IT study aims to train 40 participants in intrathecal pump refilling. Based on the learning curve during simulation-based training and the number of complete simulated refill procedures required to achieve stable procedural competence, a step-by-step standardized intrathecal pump refill protocol will be developed. The REFILL-IT study aims to contribute to the safe and correct intrathecal pump refilling in patients with chronic (non-) cancer pain and spasticity.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthcare professionals
(Healthcare) students;
Aged ≥18 years;
No prior independent performance of intrathecal pump refill procedures;
Disqualifiers
Visual impairments preventing participation in stimulated-based intrathecal pump training;
Conditions such as severe neurological or musculoskeletal disorders affecting hand function that preclude participation in the training.
Trial design
Design model
Single group
Treatments tested in this trial
Simulation-based intrathecal pump refill training
Procedure/SurgeryThe REFILL-IT study consists of two mandatory phases and an optional third clinical phase. During the Knowledge Acquisition Phase, participants will receive theoretical and practical instruction through educational videos and a written step-by-step guide. Progression requires successful completion of a knowledge assessment covering the refill procedure. In the Skill Development Phase, participants will repeatedly perform simulated intrathecal pump refill procedures using explanted SynchroMed II™ (Medtronic) dummy pumps positioned beneath a 15-mm silicone skin pad. Each procedure will be assessed as either successful or unsuccessful to evaluate the development of procedural competence. Participants who achieve stable competence and are physicians legally authorized to perform intrathecal pump refills in Belgium may progress to the Clinical Application Phase, where they will perform refill procedures in patients under the direct supervision of an experienced healthcare professional.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Simulation-based intrathecal pump refill trainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of complete simulated intrathecal pump refill procedures required to achieve stable procedural competence
The number of complete simulated intrathecal pump refill procedures required to achieve stable procedural competence will be determined using Learning Curve Cumulative Sum (LC-CUSUM) analysis.
Time frame
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application PhaseSecondary outcomes
1
Total Objective Structured Assessment of Technical Skills (OSATS) score per simulated refill procedure
Each (simulated) refill procedure will be evaluated using an OSATS-based assessment tool, assessing four predefined domains: aseptic technique, correct port access, volume verification, and procedural safety.
Time frame
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase2
Attempt-level success or failure
Each (simulated) refill procedure will be classified as successful or failed based on the OSATS score and the occurrence of critical procedural errors.
Time frame
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase3
Number and type of critical procedural errors
The number and type of critical procedural errors occurring during each simulated refill procedure will be recorded.
Time frame
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application Phase4
Number and type of procedural errors
Non-critical procedural errors, including minor deviations, delays, and technical difficulties, will be recorded during each (simulated) refill procedure.
Time frame
Immediately after the intervention, namely after the simulated intrathecal pump refill procedures during the Skill Development Phase and during the Clinical Application PhaseSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: