Implementation of Pit Crew Resuscitation Model on the Training of Advanced Life Support: a Randomized Controlled Study

November 5, 2021 updated by: Turku University Hospital

Impact of Pit Crew Resuscitation Model on Advanced Life Support Skills in a Simulated Setting: a Randomized Controlled Trial

In this study, a pit crew model is implemented in advanced life support (ALS) simulation training to student groups. The hypothesis is that the tactic model could help to maintain the CPR skills during the six month follow-up period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction

Technical skills (TS) and non-technical skills (NTS) are two sets of skills required by Crisis resource management (CRM). Sudden cardiac arrest is a time-critical emergency situation in which both skills are needed - it's handled by a team rather than by individual health-care workers.

Because of the relatively rare nature of cardiac arrests in many wards and clinics, regular resuscitation training is necessary. However, the main part of the training is traditionally emphasized to technical skills. The recent research findings of the authors suggest that the TS and NTS seem to associate in a real life resuscitation. The authors wanted to investigate if pre-allocated tasks and positions (a pit crew model) helps to perform better ALS performance and helps to maintain the skills in simulated ALS situations.

Simulation-based education (SBE) is a key tool for teaching CPR. It has demonstrated its effectiveness in promoting skill acquisition and has been suggested as an ideal tool for teaching medical skills allowing learners to engage actively in their learning process while doing no harm to their patients but its effectiveness on improving anesthesiologists NTS is unclear as the matter has not been studied. SBE is particularly good method to create trainees a realistic medical crisis situation (scenario) created within a physical space (simulator) replicating the real environment where trainees goal is to solve the problem, do the diagnose and treat the patient. Afterwards, the simulation debriefing is an crucial part of the whole letting trainees and the instructor to finish the learning process. Traditionally such training has been a standard in professions characterized by high risk caused by 'human factor' such as in aviation and other high risk industries. On the other hand the benefit for maintaining resuscitation skills learned after single SBE is modest thus short - only a few minutes a week - but frequent SBE appears to facilitate transfer of new knowledge and skills into clinical practice. SBE has been shown to improve the satisfaction of learners and skill performance in the simulated environment but it's still unclear whether it improves the patient outcome. Simulation training is expensive though so other teaching methods like mental practice and e-learning could be useful alongside it.

Catchpole and colleagues aimed to improve the quality and safety of handover of pediatric patients from surgery to intensive care using the analogy of a Formula 1 pit stop and expertise from aviation. They introduced a new handover protocol which led to improvements in all aspects of the critical situation. Based on he same idea, a novel resuscitation tactic model (a pit crew model) was developed which predetermines the roles and responsibilities of each resuscitation team members.

Purpose and hypothesis

In this study, advanced life support (ALS) skills are trained to medical students (26 persons), student nurses (52 persons) and student paramedics (26 persons). A pit crew model is taught for every other four-person resuscitation team (intervention group) and for every other group not (control group). The hypothesis is that the pit crew model could improve the quality of advanced life support immidiately after the ALS education (primary outcome) and help to maintain the ALS metrics during the follow-up period (secondary outcome). Additionally, we analyze if the pit-crew model help team physician to take hands free earlier.

Methods

The students are divided into 26 four-person resuscitation teams: one medical student, one student paramedic and two student nurses. Each resuscitation team participates on an ALS course which is based on the 2015 European (the test group) Guidelines for Resuscitation. The participants are randomized in two study arms: intervention and control. The intervention group receives ALS education according the pit crew model while the control Group received traditional ALS training. In the end of the ALS course, the resuscitation team performs a simulated resuscitation situation which is video-recorded. The TS and NTS are later analyzed by the medical professionals using detailed instrument. The hands-on ratio and the time when the team physician takes hands-free analyzed visually from the videos. Later, after six months of the ALS course, the participants will run through a simulated CPR-situation again and the data will be collected as the the same way.

The primary outcome was the difference in the total assessment score between the intervention and control groups after 6-months follow-up. The secondary outcome was the difference in ALS skills after 6-months follow-up.

Ethics The study protocol was approved by the Ethics Committee of Turku University (31/2016).

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Turku University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • medical student (fourth or fifth year)
  • paramedic student (third or fourth year)
  • nurse student (third or fourth year)
  • participated simulated ALS-situations e.g. in school before

Exclusion Criteria:

  • participated more than two real-life ALS-situations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (pit crew model group)
13 groups being taught the pit crew model
Other: The pit crew model
The pit crew model
No Intervention: control (traditional ALS education)
13 groups being taught along traditional ALS education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in the total assessment score between the intervention and control groups after 6-months follow-up.
Time Frame: 6 months follow-up
The NTS and TS are evaluated with a valid measurement tool developed for this purpose by two independent evaluators. The instrument consist of 59 items (28 items for TS and the rest for NTS) and the scale of +2 to -2 is used. Additionally, raters gave a total assessment score of performance on a scale from 0 to 10 (0=poor, 10=excellent)
6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in ALS skills after 6-months follow-up.
Time Frame: 6 months follow-up
The NTS and TS are evaluated with a valid measurement tool developed for this purpose by two independent evaluators. The instrument consist of 59 items (28 items for TS and the rest for NTS) and the scale of +2 to -2 is used.
6 months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Team physician hands-free from the hands-on work and the chest compression hands-on ratio (hands-on time divided by the total ALS time) between the groups.
Time Frame: Baseline and 6 months
These are calculated visually from the videos.
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

Turku University of Applied Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2017

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

November 12, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • T212/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Participants in the videos can be recognized. Video material can not be shared due to patient privacy. Other data is possible to share.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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