Human Factors Engineering/ Usability Engineering (Hfe/Ue) Protocol - Neopuff Ergo T-Piece Resuscitator & Co2 Detector
Usability of Respiratory Circuit and CO2 Detector for Baby Care
Edgardo Szyld
Primary Investigator
Brief description of study
The purpose of this study is to assess the usability of a respiratory circuit device and CO2 detector accessory for the care of neonates and infants. We are asking for feedback from neonatal intensive care unit (NICU) respiratory therapists (RTs), NICU registered nurses, NICU physicians and midwives, non-NICU RTs, and non-NICU physicians. Participants will be asked to set-up the system without and with a mannequin across scenarios and will be observed for any use errors.
Detailed description of study
The purpose of this human factors evaluation is to assess the usability and use-safety of the Neopuff Ergonomic Circuit and the Neopuff CO2 Detector Accessory (including the instructions for use)
The study sessions will occur at the Indiana University School of Medicine Simulation Center.Subject who agree to participate will be given a specific date and time to attend study sessions at the Simulation Center. Access to the simulation rooms during the study will be limited to participants and facilitators.
Participants will be asked to provide feedback on a device that is currently in development. There will be two parts to the study—a training session for the device and a study session in the simulation environment. In the first part of the study, they will receive education and training on the devices they will be interacting with. This will be done through review of a training video and direct in-person training with a member of our research team. This should take approximately 15-30 minutes. For the second part of the study, they will attend a study session at the IU Health Simulation Center or at Riley Hospital for Children. The study session will last approximately 45 minutes. In the study session, they will be required to perform a series of tasks in a simulated set-up of a newborn resuscitation while we will observe their experience. Participants may be required to answer a few questions at the end of each task either verbally or by using a questionnaire.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: all
-
Age: 18 years - 100 years
-
Gender: All
Inclusion criteria:
- Neonatal intensive care unit (NICU) respiratory therapists (RTs), NICU registered nurses, NICU physicians and midwives, non-NICU RTs, and non-NICU physicians
This study investigates the usability of a respiratory circuit device and a CO2 detector accessory for newborn care. The purpose is to gather feedback from healthcare professionals like neonatal intensive care unit (NICU) respiratory therapists, nurses, physicians, and midwives. Participants will be asked to set up the system in different scenarios, both with and without a mannequin, to see if there are any use errors.
Participants will be involved in two parts of the study. First, they will receive training on the devices through a video and in-person sessions. This training will take about 15-30 minutes. Then, they will attend a study session where they will perform tasks in a simulated newborn resuscitation environment. This session will last about 45 minutes, and participants may be asked some questions during or after the tasks.
- Who can participate: This study is for NICU respiratory therapists, NICU registered nurses, NICU physicians, midwives, non-NICU RTs, and non-NICU physicians. Participants must have current training, education, and competency assessment from the Neonatal Resuscitation Program (NRP).
- Study details: Participants will set up and use the respiratory circuit and CO2 detector in simulated scenarios. They will receive training and then perform tasks while being observed. Feedback will be gathered through questions and questionnaires.
