NCT05405569

Brief Summary

Cardiopulmonary resuscitation (CPR) is an emergency maneuver used in a victim who is in cardiac arrest. Early and efficient CPR, with special focus on chest compressions, is a key element to improve patient's survival. The focus for success in resuscitation should not only be the rapid onset of the maneuvers, but also the quality with which they are applied. There are several ways to improve CPR quality, taking training an important role and being relevant for skills acquisition and retention, for both healthcare professionals and laypeople. American Heart Association (AHA) recently recommended the use of technology-enhanced simulators and learning management systems to tailor the training and promote retention. Both training methodologies and support devices are built considering fundamental research, aiming the improvement of patient's outcomes. Based on these scientific developments, guidelines are established focusing on several aspects related to resuscitation, presenting variants of the procedures and considering the profile of the victim. Therefore, studying the quality of CPR and the factors that influence the rescuer's performance is very relevant. The study of fatigue in CPR maneuvers has appeared in the literature mainly after the recent updates to the guidelines. In addition to intrinsic fatigue, there are other extrinsic factors to the CPR maneuver that influence its quality, such as the posture and the position of the rescuer, among others. Most published studies investigate the influence of a single factor in CPR quality, as opposed to the combination of the above-described factors in correlation with rescuer fatigue. We consider this void in literature an opportunity to explore how these factors correlate among them, and how they influence CPR performance and quality. We anticipate that the results from this multi-centre, international project will promote rescuer awareness to specific posture/positioning that influence their fatigue and performance, through the formal development of recommendations to, ultimately, promote high quality CPR. It is expected that this study will provide translational validity, as it is expected to result in changes in current clinical practice.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

May 20, 2022

Last Update Submit

October 24, 2023

Conditions

Keywords

Cardiopulmonary resuscitationChest compressionsRescuer FatigueQuality and performance

Outcome Measures

Primary Outcomes (2)

  • Change in quality of chest compressions

    Laerdal Resusci Anne QCPR manikin with Laerdal SimPad will be used to assess chest compressions performance parameters (frequency, depth, and recoil). A standard cardiac arrest clinical scenario will be used. Based on Laerdal software, each CPR session will create a log file that will be used to analyze the performance. The log file will also provide a complete chest compressions waveform to be analyzed using a MATLAB script. This data will be synchornized with Fatigue data (namely, heart rate data), by starting the recording at the same time in the beginning of each CPR session.

    Data collection will be executed continously and synchronized during each CPR session (2 interventions, for 3 minutes each - total 6 minutes) for all participants.

  • Change in Rescuer's Fatigue

    Fatigue will be self-assessed using the Borg Scale (min. value 6 and maximum value 20, representing "very, very light" and "very, very hard", respectively), at the end of each 3-minutes exercise. Participants will also self-report fatigue, during the exercise, which will be timed with a chronometer. Heart rate data will also be collected and synchronized with chest compressions data - for this, a standard commercialized heart rate monitor will be used (included in a sports band). Borg Scale was selected as it has a direct relationship with heart rate, allowing a cross-correlation.

    Data collection will be executed continously and synchronized during each CPR session (2 interventions, for 3 minutes each - total 6 minutes) for all participants.

Study Arms (4)

Group 1

Manikin laying on the ground and rescuer kneeled on the floor

Other: CPR Arms Angle 90ºOther: CPR Arms Angle 60º

Group 2

Manikin laying on a bed at the level of the rescuer knees and rescuer standing on the side of the bed

Other: CPR Arms Angle 90ºOther: CPR Arms Angle 60º

Group 3

Manikin laying on a higher bed and rescuer standing on a step stool on the side of the bed (the manikin should be at the level of rescuers knees)

Other: CPR Arms Angle 90ºOther: CPR Arms Angle 60º

Group 4

Manikin laying on a bed and rescuer kneeled on the bed, on the side of the manikin.

Other: CPR Arms Angle 90ºOther: CPR Arms Angle 60º

Interventions

Within each independent group, a randomized crossover design will be used: half of the group will start with arms position at 90º.

Group 1Group 2Group 3Group 4

Within each independent group, a randomized crossover design will be used: half of the group will start with arms position at 60º.

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The sample will be recruited by convenience (nonprobability sample), based on the eligible healthcare professionals (nurses, physicians, paramedics, etc) available to each study partner.

You may qualify if:

  • Healthcare professionals from 18 to 65 years old;
  • Good general health and physical condition;
  • Experience in CPR performance

You may not qualify if:

  • Pregnant women;
  • Exceptional reported physical fatigue and/or muscle pain;
  • Not being able to read and understand english

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine (FMUP)

Porto, 4200-319, Portugal

RECRUITING

Study Officials

  • Carla Sa-Couto, PhD

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abel Nicolau, MSc, PhDc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2022

First Posted

June 6, 2022

Study Start

February 1, 2023

Primary Completion

December 1, 2023

Study Completion

February 1, 2024

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations