Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05695469 |
| Other study ID # |
TY/739/2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 23, 2023 |
| Est. completion date |
September 14, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
University of Turku |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this simulation-based randomized trial is to assess if the newly proposed
ResuGlove can improve the quality of chest compressions during CPR training of laypersons and
inexperienced health professionals. The main questions it aims to answer are:
1. To determine if the newly developed wearable resuscitation gloves will improve the
quality of chest compression during simulation-based CPR training
2. To determine the learnability and usability of the ResuGlove using the System Usability
Scale (SUS) questionnaire
Participants will be randomly assigned into two equal groups the ResuGlove group (group 1) vs
the traditional CPR group (Group 2). The investigators will compare the quality of chest
compression between these two groups. On the same day, participants will be asked about the
learnability and usability of ResuGlove using the System Usability Scale (SUS questionnaire.
Description:
AIM OF THE STUDY:
This study is part of an upgoing project to develop smart resuscitation gloves (ResuGlove)
that help evaluate the quality of chest compressions during CPR training. The ResuGlove are
smart-textile-based wearable technologies expected to provide real-time audiovisual feedback
on chest compression quality, including compression depth, compression rate and chest recoil.
This feasibility study aims to evaluate if the newly proposed ResuGloves can significantly
improve the quality of chest compressions compared to traditional CPR during simulated
cardiac arrest. Besides, researchers will evaluate the learnability and usability of
ResuGloves using the System Usability Scale (SUS) questionnaire.
HYPOTHESIS:
Hypothesis 1: ResuGlove will significantly improve the quality of chest compressions compared
to the traditional CPR during simulated cardiac arrest Hypothesis 2: Research participants
will positively rate the learnability and usability of the ResuGloves under development.
SIGNIFICANCE OF THE STUDY:
To begin with, the result of this preliminary feasibility study will guide the researchers on
device modification and future design. Besides, this feasibility study will help researchers
design a more extensive controlled trial study to compare the newly developed devices with
similar feedback devices during laypersons' CPR training. Once the ResuGloves are fully
developed and implemented, they will be used to train laypersons in communities. Furthermore,
the currently proposed affordable and easy-to-use textile-based ResuGloves will be used to
train health professionals in resource-limited settings. Finally, this study will open the
door for further studies to look for other health benefits of smart gloves.
METHOD:
The investigators will use a prospective randomized controlled crossover trial of two groups
to collect data on the chest compression parameters. In the first round, group 1 will perform
hand-only CPR with the help of feedback from the ResuGloves, and group 2 will perform
hand-only CPR without the ResuGlove. After 30 minutes of recovery, participants will
crossover. Besides, participants will be asked about the learnability and usability of the
ResuGlove using the system usability scale (SUS) questionnaire.
Researchers will recruit 30 volunteered nursing students from Turku University of Applied
sciences .
Researchers will announce the aim of the study to the nursing students by sending an
invitation letter via their university email addresses. The invitation letter will include
information about the study aim, confidentiality, inclusion/ exclusion criteria, and trial
design. Students will register their interest by sending an email or SMS to the emails
address or telephone numbers included in the invitation letter. Finally, a simple random
sampling will be used to draw the required number of participants, using a random numbers
generator software (https://www.randomizer.org/). Researchers conducted a pilot study of
eight participants to detect the mean difference in compression depth between the control and
the ResuGlove groups. Therefore, the sample size of the actual study (30 participants) was
estimated from the pilot study with an α error of 0.05 and a power of 0.8. The investigators
consulted a statistician to estimate the sample size of this feasibility crossover study.
Participants will be randomly assigned into two equal groups using the online-based random
number generator (https://www.random.org). In the first round, ResuGlove group will perform
hand-only CPR wearing the ResuGlove with a running feedback program for 2 minutes. On the
other hand, the traditional CPR group will perform the same way as the ResuGlove group, but
without the ResuGlove. After 30 minutes of recovery, in the second round, participants will
crossover. Ultimately, investigators will ask participants to fill out the SUS questionnaire.
Data will be presented as mean, median and percentage as necessary. Depending on the data
type, the mean difference will be analyzed using either parametric or non-parametric
statistics. A p-value of < 0.05 will be the significance threshold of our data analysis.
ETHICAL MATTERS:
Participants' autonomy will be assured by allowing them to voluntarily determine their
participation, including the right to withdraw at any time without explaining themselves.
Participants also have the right to ask questions and refuse to give information about a
specific question. In addition, participants will receive an informed consent form, the
questions to be asked and a detailed information sheet before enrolment. The information
sheet will describe the aim, methods, implications of the research, and the nature of the
participation. The investigators will collect the participants' backgrounds, such as gender,
age, CPR experience and profession. However, the investigators will not ask for sensitive
personal data such as name, income, social security number, color, ethnicity, address, and
location. Collected personal data will be coded pseudonymously and stored in a secured
computer in the Department and the University of Turku Seafile with access only to the
researchers. This way, Participants' rights to privacy, confidentiality, and anonymity will
be maintained. The collected data will be deleted once the project is completed. Only
outcomes of the analyzed data without personal identifiers will be published in an
open-access international journal. The investigators will make every effort to ensure that no
participant will be recognizable in any publication.
