Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000579695
Ethics application status
Approved
Date submitted
16/03/2023
Date registered
25/05/2023
Date last updated
10/09/2023
Date data sharing statement initially provided
25/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Chest Compression Feedback Technology in Cardiopulmonary Resuscitation (CPR)
Scientific title
The Effectiveness of Two Chest Compression Feedback Technologies on Medical Students’ CPR Performance: A Randomized Controlled Trial Simulation Study with a Crossover Design
Secondary ID [1] 308949 0
None
Universal Trial Number (UTN)
Trial acronym
CPRFT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiopulmonary Resuscitation 328956 0
Condition category
Condition code
Emergency medicine 325945 325945 0 0
Resuscitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an open-label trial. The primary intervention includes:
Intervention 1: Subjects (Basic Life Support [BLS] certified) perform CPR on a simulation CPR manikins using the TrueCPR device for CPR feedback.
Intervention 2: Subjects (BLS certified) perform CPR on a simulation CPR manikins using TCPR Link app for CPR feedback. Each subject should aim to perform CPR for five cycles of adult CPR (30 chest compressions: 2 rescue breaths).

TrueCPR is a device that provides live feedback on chest compression and consists of two pieces; one to be placed underneath the patient and another to be placed on the sternum. On the other hand, TCPR Link is a smartphone application that provides live feedback on chest compression rates.
There will be a 30-minute washout period for each subject to take reset before he/she crossovers to the next CPR performance.
The secondary intervention is that the subjects (BLS certified) are instructed to count the chest compression loudly during CPR in a crossover design. As in the primary intervention, each subject should aim to perform CPR five cycles of adult CPR (30 chest compressions: 2 rescue breaths) for this intervention. For the counting loudly approach, each subject will be kept with the same group of intervention (e.g., subjects who do CPR with TrueCPR and count loudly their chest compressions will do it again with the same feedback technology [TrueCPR in this case] but not loudly count their chest compression).

A BLS instructor with a note sheet will supervise and monitor the subject's performance and instruct him/her to count loudly for the secondary intervention as well as to make sure that the QCPR simulation manikin (Little Anne® QCPR® manikin - adult size) is monitoring the performance of the subject for both interventions. Another data collector will obtain the vital signs of the subject immediately before and after the CPR session.
Intervention code [1] 326155 0
Treatment: Other
Comparator / control treatment
Controls: Subjects (BLS certified) perform CPR on a simulation CPR manikin without any feedback for a course of performing five cycles of adult CPR (30 chest compressions: 2 rescue breaths). Then, the subject will take rest for 30 minutes, and proceed with another 5 minutes of CPR according to the crossover design (e.g., who does CPR counting loudly with CPR for the second time with no loudly counting chest compression, and vice versa).
Controls for the secondary intervention: Subjects (BLS certified) perform CPR on a simulation CPR manikin with no loud counting the chest compression in a crossover design.
Control group
Active

Outcomes
Primary outcome [1] 333796 0
Proportions of effective chest compressions using different instant CPR feedback technologies. Chest compression and successful ventilation attempts will be monitored and assessed by Little Anne® QCPR® manikin.
Timepoint [1] 333796 0
During the performing course of five adult CPR cycles (30 chest compressions: 2 rescue breaths).
Primary outcome [2] 334834 0
The number of successful ventilation attempts. Successful ventilation attempts and their rate compared to the chest compressions will be assessed and reported by Little Anne® QCPR® manikin.
Timepoint [2] 334834 0
During the performing course of five adult CPR cycles (30 chest compressions: 2 rescue breaths).
Secondary outcome [1] 418343 0
Rescuer fatigue level among subjects. Each subject’s vital signs will be checked prior to and post every attempt to perform CPR in order to examine the level of fatigue as the difference in heart rate (HR), respiratory rate (RR), and mean arterial pressure (MAP). The subject's vital signs will be assessed and obtained by a healthcare provider (respiratory therapist) with a reliable digital vital sign apparatus. The respiratory therapist will assess and record the subject's respiratory rate during checking the other vital signs.
Timepoint [1] 418343 0
Immediately before and after each attempt of performing five adult CPR cycles.

Eligibility
Key inclusion criteria
A medical student of one of the following bachelor-level programs: Medicine and Surgery, Nursing, Emergency Medical Services, and Respiratory Care who has a valid BLS, Advanced Cardiovascular Life Support (ACLS), or Paediatric Advanced Life Support (PALS) certificate from either the American Heart Association (AHA) or the Saudi Heart Association (SHA).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Candidate is unable to sign the consent form or collaborate in the study.
2. Candidate do not have a life support certificate (BLS, ACLS, or PALS) or have an expired one.
3. Pregnant candidates.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each enrolled subject will be given a unique ID number starting with 1 to n in a sequential order for all strata. Then, the set of IDs for each stratum will be entered in the randomizer engine (www.randomizer.org) to allocate those numbers randomly on the study arms with no human control or determination of which ID goes to which cohort or arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
First, stratification for the sample pool will be defined based on pre-determined characteristics (i.e., program of study, BLS v. ACLS/PALS, sex, practical exposure), Then, the subjects will be assigned with ID in a sequential order. Finally, IDs for each stratum will be randomly assigned to one of six cohorts by using a randomizer engine (www.randomizer.org).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Parallel groups for primary intervention and crossover within each primary groups for the secondary intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analysis for the primary findings and inferential analysis for testing the relationships between the outcomes and predetermined characteristics of the subjects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/11/2023
Actual
Date of last participant enrolment
Anticipated
15/10/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment outside Australia
Country [1] 25252 0
Saudi Arabia
State/province [1] 25252 0
Makkah

Funding & Sponsors
Funding source category [1] 313161 0
University
Name [1] 313161 0
Umm Al-Qura University
Country [1] 313161 0
Saudi Arabia
Primary sponsor type
University
Name
Umm Al-Qura University
Address
Umm Al-Qura University
Taif Road, Alabdiyyah Campus,
Makkah, 24381
Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 314877 0
Hospital
Name [1] 314877 0
King Abdullah Meedical City
Address [1] 314877 0
Clinical Simulation Administration
Executive Administration of Academic Affairs and Training
King Abdullah Medical City (KAMC)
Al Mashair, Makkah 24246
Saudi Arabia
Country [1] 314877 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312404 0
Biomedical Research Ethics Committee of the Faculty of Medicine at Umm Al-Qura University
Ethics committee address [1] 312404 0
Administration Building
The Standing Committee on Scientific Research Ethics
The Vice-Presidency For Graduate Studies and Scientific Research
Umm Al-Qura University
Makkah 24381
Saudi Arabia
Ethics committee country [1] 312404 0
Saudi Arabia
Date submitted for ethics approval [1] 312404 0
05/11/2022
Approval date [1] 312404 0
18/11/2022
Ethics approval number [1] 312404 0
HAPO-02-K-012-2022-11-1272

Summary
Brief summary
The chest compressions (CCs) and adequate ventilation are crucial techniques to save lives in basic life support (BLS) and in advanced cardiac life support (ACLS) procedures for cardiopulmonary arrest cases. This open-label RCT simulation study aims to investigate the effectiveness of students’ performance in medical and allied health programs and examine the effectiveness of two different instant CC feedback technologies on the students' CPR performance: effective CCs and the fatigue level. We hypothesize that different feedback technologies and counting loudly increase the proportions of the effective chest compressions during CPR. The study will utilize a randomized controlled trial design where three matched samples (intervention 1 intervention 2 and control) of students from four medical sciences programs at a large university in the western region of Saudi Arabia will be recruited in this study to investigate their chest compression performance and ventilation according to BLS guidelines on a manikin. A crossover design is nested in the RCT to measure and control the effect of a secondary technique during CPR. The analyses will investigate the baseline CPR performance among different determinants (e.g., students’ study programs knowledge retention on BLS practice exposure physical fitness and sex). Then, the effect of feedback devices will be analyzed with controlling those determinants. The expected study findings could help the researchers and academic program designers about the efficacy of feedback on improving chest compression performance. The expected findings could inform us on the factors that either challenge or enhance the individuals’ performance in CPR.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124538 0
Dr Abdulhadi A. Al Ruwaithi
Address 124538 0
Al Taif Road, University Capmus at Alabdiyyah
Faculty of Applied Medical Sciences
Umm Al-Qura University
Makkah 24381
Saudi Arabia
Country 124538 0
Saudi Arabia
Phone 124538 0
+966564689219
Fax 124538 0
Email 124538 0
aaruwaithi@uqu.edu.sa
Contact person for public queries
Name 124539 0
Dr Abdulhadi A. Al Ruwaithi
Address 124539 0
Al Taif Road, University Capmus at Alabdiyyah
Faculty of Applied Medical Sciences
Umm Al-Qura University
Makkah 24381
Saudi Arabia
Country 124539 0
Saudi Arabia
Phone 124539 0
+966564689219
Fax 124539 0
Email 124539 0
aaruwaithi@uqu.edu.sa
Contact person for scientific queries
Name 124540 0
Dr Abdulhadi A. Al Ruwaithi
Address 124540 0
Al Taif Road, University Capmus at Alabdiyyah
Faculty of Applied Medical Sciences
Umm Al-Qura University
Makkah 24381
Saudi Arabia
Country 124540 0
Saudi Arabia
Phone 124540 0
+966564689219
Fax 124540 0
Email 124540 0
aaruwaithi@uqu.edu.sa

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Age, sex, height, weight, level of life support certificates, body activity questionnaire scores, level of CPR performance, proportions of effective chest compression.
When will data be available (start and end dates)?
Start date: immediately following publications. End date: five years after data collection is completed.
Available to whom?
Researchers want to access it.
Available for what types of analyses?
Meta analysis studies.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Dr. Abdulhadi Al Ruwaithi at aaruwaithi@uqu.edu.sa).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18332Study protocol  aaruwaithi@uqu.edu.sa 385370-(Uploaded-13-02-2023-16-38-14)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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