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Testing, RealityResuGloveNCT05695469

The Impact of ResuGlove as a Chest Compression Feedback Device

A study testing Smart resuscitation glove (ResuGlove) and Traditional CPR in people with Testing, Reality, run by University of Turku at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Testing, Reality
What is being tested?
Smart resuscitation glove (ResuGlove) and Traditional CPR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteFinland
Study dates
23 May 2023to 14 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Nursing student from Turku University of Applied Sciences
  • Students have a minimum of basic life support training
  • Participants should be able to understand and communicate in English

Who cannot join

  • Participants must not have previous experiences in actual patient resuscitation.
  • Participants who are not able to understand and communicate in English
  • Students with known cardiac/pulmonary diseases, back pain, and wrist problems

Trial locations and contacts

1 site in 1 country.

Finland1 site
  • University of Turku

    Turku, Southwest, 20520

Other trials in Finland

About this study

Official title: The Impact of Smart Resuscitation Glove (ResuGlove) as Chest Compression Feedback Devices During CPR Training: Feasibility Study of the Device Under Development

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.

Read the detailed 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.

Being tested
Smart resuscitation glove (ResuGlove), Traditional CPR
Keywords
Smart glove, CPR training, Sensibility study, Realtime feedback

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smart resuscitation glove (ResuGlove)Device

    Participants will be randomly assigned into two equal groups using the online-based random number generator (https://www.random.org). Participants in the ResuGlove group will perform hand-only CPR wearing the ResuGlove with a running feedback program for 2 minutes.

  • Traditional CPROther

    Participants in the traditional CPR group will perform hand-only CPR without the ResuGlove and feedback guidance for 2 minutes.

Study groups in NCT05695469
Study groupRoleWhat they receive
ResuGlove groupExperimentalParticipants in the ResuGlove group will be guided by the audio feedback from the smart resuscitation glove.
Receives: Device: Smart resuscitation glove (ResuGlove); Other: Traditional CPR
Traditional CPR groupActive comparatorParticipants in the traditional CPR group will perform chest compressions without guidance from the smart resuscitation glove.
Receives: Device: Smart resuscitation glove (ResuGlove); Other: Traditional CPR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Chest compression depth

    Chest compression depth is one of the most critical components of quality CPR. The current International Liaison Committee on Resuscitation (ILCOR) guidelines recommended a chest compression depth of 5-6 cm for improved outcomes.

    Measured: At zero time point (first round) and crossover at 30 minutes (second round)

  2. Average chest compression rate

    The compression rate is another essential component of quality CPR. The current International Liaison Committee on Resuscitation (ILCOR) guidelines recommended a chest compression rate of 100 to 1200 per minute for improved outcomes.

    Measured: At zero time point (first round) and crossover at 30 minutes (second round)

  3. Proportion of chest recoil

    Complete chest release (recoil) between each compression is essential to allow the heart to accumulate blood to be pumped during compressions. Therefore, the International Liaison Committee on Resuscitation (ILCOR) guidelines recommended complete chest recoil (100%) during CPR for a better outcome.

    Measured: At zero time point (first round) and crossover at 30 minutes (second round)

Secondary outcomes (3)
  1. The proportion of correct compression depth

    The percentage of correct compression to a depth of 5-6cm within the two minutes

    Measured: At zero time point (first round) and crossover at 30 minutes (second round)p

  2. The proportion of correct compression rate

    The proportion of correct compressions to a rate of 100 to 120 per minute within the two minutes

    Measured: At zero time point (first round) and crossover at 30 minutes (second round)

  3. Learnability and usability of the ResuGlove under development

    Participants will be asked about the learnability and usability of ResuGlove at the end of the intervention. For the learnability and usability evaluation, we will use the System Usability Scale (SUS) questionnaire, initially developed by Brooke (1996) and modified later for various technological products. The questionnaire is quick and easy to be used by the study participants. It provides a single score on a scale understood by many people. The SUS has ten statements, in which the odd numbers are positively worded, and the negative numbers are negatively worded. The final score for the SUS will range from 0 to 100. A higher score will indicate better learnability and usability.

    Measured: At the end of the second round (30 to 40 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start23 May 2023
  3. Primary completion14 Sep 2023
  4. Study completion14 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
The randomly selected participants will be randomly assigned into two equal groups using the online-based random number generator (https://www.random.org). In the first round, group 1 will perform hand-only CPR wearing the ResuGlove with a running feedback program for 2 minutes. On the other hand, group 2 will perform the same way as group 1, but without ResuGlove. After 30 minutes of recovery, in the second round, they will crossover. Ultimately, we will ask participants to fill out the SUS questionnaire.
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05695469
Sponsor's protocol ID
TY/739/2022
Acronym
ResuGlove
Status last verified
Sep 2023
First submitted
1 Dec 2022
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only outcomes of the analyzed data without personal identifiers will be publicly available after being published in an international journal.

Questions about this trial

What is this clinical trial studying?

A study testing Smart resuscitation glove (ResuGlove) and Traditional CPR in people with Testing, Reality, run by University of Turku at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Chest compression depth (time frame: At zero time point (first round) and crossover at 30 minutes (second round)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.

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