Human Factors Validation Testing for the Peripal System; a Manual Connection Assist Device for Peritoneal Dialysis Devices

NCT04292210 | Completed

• 1 other identifier: IRAS ID :235715
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but only approximately 11% of prevalent dialysis patients use this modality. Connection-assist devices can overcome the challenges posed by decreased manual dexterity and/or visual acuity, and can allow more patients to be treated with home-based therapies. As part of the CE marking authorization, a connection device has been evaluated for safety and ease of use in a usability study.

Conditions

End Stage Renal Failure on Dialysis; End Stage Renal Disease on Dialysis; Renal Failure; Peritoneal Dialysis; Renal Replacement Therapy

Keywords

patient safety; usability study; connection-assist device; ease of use; peritoneal dialysis; NASA Task Load Index; renal replacement therapy

Outcome Measures

Primary Outcomes (3)

• Safety and ease of use of a connection device during a continuous ambulatory peritoneal dialysis

  Firstly, a training session introduced the operation of the device. The normal steps of a manual connection and breaking of the frangible is replaced by the levers and the buttons in the device. The connections are thereby done in a 'safe' environment which reduces infection risk. A whole cycle of continuous ambulatory peritoneal dialysis is simulated during each training. Secondly, a break of one hour allowed relaxation and recovery. Thirdly, a test was carried out to determine whether the subject could use the device independently with the aid of a quick start guide and the device manual. The training consisted of two cycles in which the moderator guided the subject and three cycles in which the subject guided the moderator through the complete handling of the device. Each of the 24 subjects performed 52 handling steps resulting in a total of 1248 evaluated handling steps.

  3 hours

• Nasa Task Load Index (N-TLX)

  The operating procedure of the device consists of multiple tasks comprising several handling steps. the subjects were asked about the task load in six different dimensions in the standardized N-TLX. Task load is a hypothetical construct that represents the cost incurred by a human operator to achieve a particular level of performance. The dimensions of the N-TLX are mental, physical and temporal demands as well as performance, effort and frustration in the task. Each dimension is evaluated on a 20-point scale. This scale is then transferred to the task load index, which is a scale between 0 and 100 points. Workload levels below 50 were perceived as acceptable.

  3 hours

• Observation of technique

  Here the observations of technique errors were discussed with the subjects in order to identify the specific causes. In this interview, the subjects were also asked for their feedback on the general ease of use of the device.

  3 hours.

Study Arms (1)

CAPD handling

EXPERIMENTAL

A connecting device simplifying the steps during a cycle of Peritoneal dialysis. Instead of directly doing a manual connection and manually breaking a frangible, the device assist in connecting and breaking the frangible. This study was done demonstrating a continuous ambulatory peritoneal dialysis (CAPD)

Device: Perisafe

Interventions

Perisafe DEVICE

A medical device simplifying the connection of tubing as well as breaking of the frangible which is done in a sterile environment with the help of levers and buttons.

CAPD handling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Fifteen patients and nine carers volunteered in this study, ranging from 23 to 86 years in age and from 0.3 to 24 years in experience in the PD therapy.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Peripal AG: lead
• Swiss Federal Institute of Technology: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator

Study Sites (1)

NIHR Trauma Management MedTech Co-operative

Birmingham, United Kingdom

Location

Related Links

• Evaluating Patient Safety and Ease of use of a Novel Connection-Assist Device for Peritoneal Dialysis

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Lukas Foggensteiner, MD, PhD

  National Health Service, United Kingdom

  STUDY CHAIR

• Mirko Meboldt, PhD

  ETH

  STUDY CHAIR

• Martin Dubach

  Peripal AG

  STUDY CHAIR

• Stephan Hess

  ETH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The training consisted of two cycles in which the moderator guided the subject and three cycles in which the subject guided the moderator through the complete handling of the device. For each subject, one moderator and one observer were involved in the study. The moderator was the interface between the subject and the device both in training and in testing. This person was employed by an external agency to avoid any influence on the subject. The observer saw the handling with the help of a live feed from a separate room. He evaluated the handling steps in the categories of "safe use" and "use error" according to IEC 62366-1 (2015). For each use error, the observer described the observed situation from his point of view.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The growth in the RRT population is primary in the elderly age group, a population with a high frailty and comorbidity burden. Facilitating PD in this group of patients requires improved PD technology with greater accessibility tailored to patient needs. It is proposed that by making PD treatment simpler, more standardized and better protected from infections, patient access to PD could be increased significantly. Following evaluation of specific barriers to the use of PD including feedback from established PD patients, a novel connection-assist device has been developed. As part of the CE marking authorization, the connection device has been evaluated for safety and ease of use in a study at University Hospitals Birmingham NHS Foundation Trust involving 24 patients and carers.

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: March 3, 2020
• Study Start: February 19, 2018
• Primary Completion: March 12, 2018
• Study Completion: April 30, 2018
• Last Updated: March 3, 2020

Record last verified: 2020-02

Locations

GB (1)