The Impact of ResuGlove as a Chest Compression Feedback Device

NCT05695469 | Completed

• 1 other identifier: TY/739/2022
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 1.To determine if the newly developed wearable resuscitation gloves will improve the quality of chest compression during simulation-based CPR training
2. 2.To determine the learnability and usability of the ResuGlove using the System Usability Scale (SUS) questionnaire

Conditions

Testing, Reality

Keywords

Smart glove; CPR training; Sensibility study; Realtime feedback

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Secondary Outcomes (3)

• The proportion of correct compression depth

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

• The proportion of correct compression rate

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

• Learnability and usability of the ResuGlove under development

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

Study Arms (2)

ResuGlove group

EXPERIMENTAL

Participants in the ResuGlove group will be guided by the audio feedback from the smart resuscitation glove.

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.

Device: Smart resuscitation glove (ResuGlove); Other: Traditional CPR

Interventions

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.

ResuGlove group; Traditional CPR group

Traditional CPR OTHER

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

ResuGlove group; Traditional CPR group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turku: lead
• Aalto University: collaborator

Study Sites (1)

University of Turku

Turku, Southwest, 20520, Finland

Location

Study Officials

• Desale T Kahsay, MSc

  University of Turku

  PRINCIPAL INVESTIGATOR

• Sanna Salanterä, Professor

  University of Turku

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral researcher

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: January 25, 2023
• Study Start: May 23, 2023
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: When the summary data is published and made available by the Journal
• Access Criteria: Access will be possible through the Journal website. The principal investigator is ready to share additional information regarding the trail following a genuine request.

Locations

FI (1)