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.
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.
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:
- To determine if the newly developed wearable resuscitation gloves will improve the quality of chest compression during simulation-based CPR training
- 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.
- Conditions
- Testing, Reality
- 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 group | Role | What they receive |
|---|---|---|
| ResuGlove group | Experimental | Participants 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 group | Active comparator | Participants 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.
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)
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)
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)
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
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)
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.
- First posted25 Jan 2023
- Study start23 May 2023
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testing, RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Aalto University
- Responsible party
- Principal investigator, Desale Tewelde Kahsay, University of Turku
- Investigators
- Desale T Kahsay, MSc, Principal investigator, University of TurkuSanna Salanterä, Professor, Study chair, University of Turku
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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Smart Resuscitation Glove (ResuGlove) as Chest Compression Feedback Devices During CPR Training: Feasibility Study of the Device Under Development
- ClinicalTrials.gov ID
- NCT05695469
- Acronym / sponsor ID
- ResuGlove / TY/739/2022
- Conditions
- Testing, Reality
- Keywords
- Smart glove, CPR training, Sensibility study, Realtime feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Aalto University
- Study start
- 23 May 2023 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine if the newly developed wearable resuscitation gloves will improve the quality of chest compression during simulation-based CPR training
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ResuGlove group | Experimental | Device: Smart resuscitation glove (ResuGlove), Other: Traditional CPRParticipants in the ResuGlove group will be guided by the audio feedback from the smart resuscitation glove. |
| Traditional CPR group | Active comparator | Device: Smart resuscitation glove (ResuGlove), Other: Traditional CPRParticipants in the traditional CPR group will perform chest compressions without guidance from the smart resuscitation glove. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart resuscitation glove (ResuGlove)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. | Device | ResuGlove group, Traditional CPR group |
| Traditional CPRParticipants in the traditional CPR group will perform hand-only CPR without the ResuGlove and feedback guidance for 2 minutes. | Other | ResuGlove group, Traditional CPR group |
Primary outcome
Average Chest compression depth
Time frame: At zero time point (first round) and crossover at 30 minutes (second round)
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.
Average chest compression rate
Time frame: At zero time point (first round) and crossover at 30 minutes (second round)
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.
Proportion of chest recoil
Time frame: At zero time point (first round) and crossover at 30 minutes (second round)
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.
3 secondary outcomes
The proportion of correct compression depth
Time frame: At zero time point (first round) and crossover at 30 minutes (second round)p
The proportion of correct compression rate
Time frame: At zero time point (first round) and crossover at 30 minutes (second round)
Learnability and usability of the ResuGlove under development
Time frame: At the end of the second round (30 to 40 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: Yes. Only outcomes of the analyzed data without personal identifiers will be publicly available after being published in an international journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Desale T Kahsay, MSc principal investigator
University of Turku
Sanna Salanterä, Professor study chair
University of Turku
1 site in 1 country: see every site and its status.
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.