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Clinical Trials/NCT05405569
NCT05405569RecruitingNot Applicable

Influence of Posture and Positioning in Rescuer's Fatigue and Quality of Chest Compressions: a Simulation-based Exploratory Study

Universidade do Porto1 site in 1 country60 target enrollmentStarted: February 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Change in Rescuer's Fatigue

Study Overview

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.

Detailed Description

The aim of this study is to evaluate how positioning and posture of the rescuer promote fatigue and influence the quality of chest compressions. These factors have been selected based on available literature, researchers' experience and feasibility, aiming to answer the research question: in healthcare professionals experienced in CPR, does specific body position and arms angle promote fatigue and influence the quality of chest compressions?

Through this research question we will explore:

  1. The influence of positioning during CPR in rescuers fatigue;
  2. The influence of the arms angle during CPR in rescuers fatigue; and
  3. The correlation between rescuer fatigue during CPR (under specific conditions) and the quality of chest compressions.

It is expected that the conclusions of this research will promote rescuer awareness and behavioral change, leading to better patient outcomes.

Study Design An international multicentric randomized manikin study will be implemented. The protocol development will consider the most recent CONSORT guidelines for randomized clinical trials (RCTs) and the inputs from the experienced research team with formal training in emergency care, simulation-based training, and quantitative research methodology. The protocol will be revised by healthcare professionals, specialized in emergency care and experienced in CPR, from our university hospitals. Formal registration of the protocol will be done to ClinicalTrials.gov. Prior to the study implementation, the study protocol will be submitted for ethical/institutional approval.

Study Design

Study Type
Observational
Observational Model
Case Crossover
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in Rescuer's Fatigue

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

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.

Change in quality of chest compressions

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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