Non-technical Skills Training and Checklists Versus Standard Training With Checklists in Boarding School Students to Reduce Simulation Crisis Medical Error, Randomized Controlled Clinical Trial
Phase: NA
Conditions: Medical Emergencies
Sponsor: Universidad de Antioquia

TITLE: Non-technical skills training and checklists versus standard training with checklists 
in boarding school students to reduce simulation crisis medical error, randomized 
controlled clinical trial. 
 TECRISIS study  
 
DATE: 03/11/2020 
 
 
 
 
 
 
 
Author: Mario Andrés Zamudio Burbano 
Clinical Epidemiology Master's Student 
 
 
Director of research  
Fabián David Casas Arroyave 
Master in Clinical Epidemiology  
  
 
 
 
 
 
 
School of Medicine  

University of Antioquia 
Index  
I Administrative information 
 
one. Title 
 
2. Study registration  
 
3. Protocol version  
 
4. Financing  
 
5. Roles and Responsibilities 
II introduction  
 
6. Background and justification  
 
7. Objectives and hypothesis  
 
8. Study design  
III Methods: Participants, interventions and outcomes  
 
9. Description of the study characteristics  
 
10. Inclusion and exclusion criteria 
 
11. Interventions  
 
12. Outcomes  
 
13. Participants timeline  
 
14. Sample Size 
 
15. Recruitment 
IV Methods: Assignment of interventions  
 
16. Assignment  
 
17. Blinding  
V Methods: Data collection, management and analysis  
 
18. Data Collection Methods 
 
19. Data Management 
 
20. Statistical methods 
VI Methods: Monitoring  
 
21. Data Monitoring 

 
22. Damage  
 
23. Audit  
VII Ethics and dissemination  
 
24. Approval by ethics committee  
 
25. Modifications to the protocol  
 
26. Informed Consent  
 
27. Confidentiality  
 
28. Declaration of conflict of interest  
 
29. Access to data 
 
30. Post-study care 
 
31. Dissemination policy 
VIII Appendices 
 
32. Informed consent 

I. 
Administrative information  
 
1. Title: Training in non-technical skills and checklists versus standard training with 
checklists in boarding school students to reduce simulation crisis medical error, 
randomized controlled clinical trial. 
 
2. Protocol Record  
2. a Protocol registration: will be done in Clinical Trial once completed 
2. b Data record according to recommendations of the World Health Organization in 
Table 1. 
Table 1. WHO data record  
Fact 
information  
Registration and identification 
number  
Pending  
Registration date  
Pending  
Secondary registration number  
Pending  
Sources of funding  
University of Antioquia  
Primary Sponsor  
University of Antioquia  
Secondary Sponsor 
None 
Contact for public inquiries 
Zamudio Mario email: mario.zamudio@udea.edu.co  
Contact for scientific inquiries  
Zamudio Mario email: mario.zamudio@udea.edu.co 
Public Title 
TECRISIS study 
Scientific Title  
Non-technical skills training and checklists versus standard 
training with checklists in boarding school students to 
reduce simulation crisis medical error, randomized 
controlled clinical trial. 
Recruitment Country  
Colombia  
Problem Studied  
Medical error: omission of management steps in medical 
crises 
Interventions 
Intervention: training in non-technical skills and checklists  
Control: standard training with checklists  
Inclusion and exclusion criteria  
Inclusion: over 18 years. 
Final semester student of medicine at the University of 
Antioquia.  
Have passed the theoretical knowledge exam for handling 
crisis events with a score of 100%. 
On-site availability on training days 
Exclusion: having received training in a specific crisis 
resource management course. Refusing to participate  
 
Type of study  
Intervention  

Superiority 
 
Recruitment Start Date  
Pending  
Target sample size  
56 participants 
Study status 
Elaboration of protocol  
Primary outcome 
Proportion of omissions of treatment steps per group.  
Secondary outcomes  
Crisis resolution time  
 
Time in detection and discrimination of the crisis  
 
Overall score of non-technical skills  
 
Discriminated score between dimensions of non-technical 
skills  
 
Student satisfaction  
 
Incidence of inadequate crisis management  
 
3. Table 2. Protocol Version:  
Version 
Date 
Modifications  
 
one 
November 03, 2020 
 
Mario Andrés Zamudio 
 
4. Financing: simulation center of the Faculty of Medicine, University of Antioquia and 
Authors. 
5. Table 3. Research roles  
Name 
Assignment  
Contributions  
Mario Andrés Zamudio Burbano 
Principal investigator 
Preparation of protocol, collection 
of patients, statistical analysis, 
dissemination of results. 
Fabian David Casas Arroyabe 
Director of research  
Protocol review. 
Juan Pablo Zapata 
Co-investigator  
Protocol review, patient collection.  
  
 
 
 
 
 
 

 
II. 
Introduction  
6a. Background 
Medical Error 
Medical error defined as an "unintentional act of omission or commission that does not 
result in the intended result, lack of planning, use of improper plan, or deviation from the 
plan of care that may or may not harm a patient"(one)it is a big public health problem. For 
2013, it was estimated that medical error was the third leading cause of death in the United 
States.(2); and in Latin America the preventable adverse event and the injury secondary to 
medical error(3), has a prevalence of 10.5% (95% CI 9.91 to 11.04) of health care (4). A 2008 
prospective multicenter cohort in Colombia described a cumulative incidence of 4.6% (95% 
CI 4.1 to 5.1) for preventable adverse events, with underreporting estimated by the authors 
of 20 to 40% (5), with similar incidents described in intensive care units(6)(7).  
Medical error has been described in several contexts: skipping treatment steps in critical 
situations(8)medication error(9), diagnostic error(10), among others. Depending on the 
context, the encoding of such errors can include more than 400 types(eleven). Dovey et al. 
Propose a taxonomy of medical error in the following way: administrative failures; research 
failures, understood as the clinical and paraclinical search for a medical pathology; 
treatment failures; communication errors; failure in treatment decision; and diagnostic 
error(12).  
However, from a cognitive point of view, medical error can be classified into two categories: 
slip, as that incorrect execution of a correct sequence of action; and error, such as the 
correct execution of an incorrect action sequence, each category in turn can be directed to 
treatment or diagnosis(13). 
The omission of treatment steps in medical crises, that is, medical error in cardiac arrest or 
those code situations, is of special relevance given the severity of the context and the risk 
of mortality or serious adverse events, and due to the high incidence reported for this 
context, which is between 26 and 50%(8); with similar incidents for trained and training 
personnel(14). 
Among the types of medical errors, those due to omission of treatment steps in code crises, 
that is, life-threatening situations such as acute pulmonary thromboembolism, acute heart 
failure, unstable arrhythmias, among others; they are the ones that can have the greatest 
impact on serious complications and mortality. In a retrospective review of over a million 
medical errors, those related to code situations, represented a large increase in the 
probability of patient harm and death with an OR of 39 (95% CI 28.6 to 51.4 ) for adverse 
event and OR of 51 (95% CI 16.4 to 124.6) for death compared to medical errors not related 
to acute situations(fifteen).  

Although it is a controversial topic, among the potential causes of medical error are: lack of 
knowledge, cognitive biases, failure in technical ability, failure in non-technical ability such 
as (communication failure, fatigue, stress management, sleep disorders , failures in 
situational awareness), severity of the patient's disease, factors external to the doctor-
patient relationship, among others(10). Figure 1 shows a potential causal diagram of this 
phenomenon made with the dagitty tool.(16). 
 
Figure 1. Potential causal diagram. 
 
HNT: non-technical skills 
Source: Authors 
Despite the causal complexity of medical error, a large part of these possible causal factors 
have been grouped into what are known as non-technical skills, highlighting their 
importance in the development of this clinical event. In a Japanese study analyzing cases of 
medical errors leading to mortality, 55% were explained by failures in non-technical skills, 
45% by disease severity and only 5% by failure of technical ability.(17). In the National Audit 
Poject NAP 4 study, a UK national audit that in 2011 analyzed 286 incident cases of difficult 
airway complications in anesthesia, critical care and emergency unit at 307 hospitals, 
described 40% of serious complications are explained by failures in non-technical skills(18). 
In a database study of reports of adverse events in orthopedics, an association with medical 

error of mortality and non-technical skills was found in 65% of cases.(19). Several studies 
have associated performance in technical and non-technical skills.(twenty)(twenty-one). 
Non-technical skills 
Non-technical skills can be defined as the set of psychosocial skills that complement 
technical skills, an concept extrapolated from aviation. Flin and collaborators in 2004 
described 4 categories: leadership, leadership skills, cooperation, situational awareness, 
and decision making; based on studies in the field of aviation(22). The following categories 
have recently been described in the field of medicine: 
Leadership and resource management: it is understood as the ability to remain calm to lead 
a medical team and distribute assignments according to the skills and needs of each team 
member, within the resources both human talent and technological, technical and cognitive 
aids such as checklists(2. 3).  
Assertive communication: manifests itself as the effective transmission of information and 
shared interpretation of the situation. Non-assertive communication is associated with both 
medical and nursing errors, for example, in the safe administration of medications.(24). 
Situational awareness:It is a cognitive ability that manifests itself by identifying the relevant 
information in a setting in order to evaluate strategies and imagine possible results of these, 
taking the best possible result. Association has been found between situational awareness 
and procedural error in surgery(25). 
Clinical decision making and problem solving: The ability to evaluate possible decisions, 
compare the results, choose and execute the action that best suits the context is 
considered. Clinical decision-making has been of special interest since there are two 
described types of reasoning: type 1 uses a fast or heuristic path and type 2 uses a 
hypothetical deductive path that requires more cognitive resources; when a heuristic leads 
to an inappropriate decision it has been called cognitive bias(10).  
Since teamwork can be simulated(26)There is an interest in training non-technical skills in 
order to improve patient safety. The most important studies on interventions in non-
technical skills, resource management in crisis and standard training, regarding medical 
error or performance in crisis are summarized in Table 4. 
Table 4. Previous studies on non-technical skills or medical error.  
Reference  
Intervention  
Control  
Outcome  
Observation  
Type of study 
Müller 
MP 
and Cols.(27) 
1 Day Resource 
Management in 
MRC Crisis 
1 
day 
of 
simulation 
in 
crisis 
Stress 
and 
performance  
Performance measured 
with checklists and HNT 
with 
ANTS 
scale 
improved in both groups 
without 
differences 
between arms.  
Clinical trial  

Khoo EM and 
Cols.(28) 
Educational 
package 
of 
methods 
and 
processes.  
Conventional 
management 
before 
intervention  
Diagnostic and 
treatment 
errors 
Decrease 
of 
medical 
error 54.0% (CI 49.9-
58.0) to 36.6% (CI 30.2- 
43.1) 
Clinical trial  
Starmer and 
Cols. (29) 
Handoff training 
program 
focused 
on 
organizational 
culture 
and 
communication 
Conventional 
management 
before 
intervention  
Medical 
error 
and 
adverse 
event 
in 
a 
pediatric 
hospital  
Reduction of incidence 
of medical error 24.5 vs 
18.8 per 100 admissions 
P <0.001 
Study Before 
and after 
Wetmore 
et 
al.(30) 
Use 
of 
anesthesia 
reinduction 
checklist  
Simulation 
training without a 
checklist 
Performance 
measured 
as 
skipping 
preparation 
steps  
Improvement 
of 
7.8 
points 
out 
of 
22 
possible.  
Simulated 
controlled 
clinical trial  
Duclos 
and 
Cols. (31) 
Crisis 
resource 
management 
course 
plus 
checklists  
Checklists  
Serious adverse 
events 30 days 
after surgery 
8⋅8 to 5⋅5% (OR 0⋅57, 
95% CI 0⋅48 to 0⋅68 
versus 7⋅9 to 5⋅4% in 
control (OR 0⋅64, 0⋅50 to 
0⋅81 ROR 0.67 to 1.21. 
Controlled 
clinical trial 
Doumouras 
and Cols.(32) 
Non-technical 
skills training  
Out of control  
Crisis resolution 
time 
Each point on the ANTS 
scale 
decreased 
the 
crisis resolution time by 
53 seconds 
Prospective 
cohort  
Arriaga 
and 
Cols. (33) 
Training 
with 
checklists 
Conventional 
training  
Errors 
in 
omitting 
treatment steps 
in crisis 
Absolute risk reduction: 
17% Relative risk of 0.28. 
IC0.18 
to 
0.42; 
P 
<0.001 
Simulated 
controlled 
clinical trial 
HNT: Non-technical skills, MRC: resource management in crisis. ANTS: Non-technical Skills 
Scale for Anesthesiologists. 
The problems with the studies carried out up to the moment of carrying out this protocol, 
in relation to medical error and non-technical skills, are varied. In the pilot study by Müller 
et al.(27), in which no sample size was calculated, a training day in resource management 
in CRM crisis was compared, a course that includes some dimensions of non-technical skills: 
leadership, assertive communication, situational awareness versus conventional medical 
management training in two scenarios in simulation; hemorrhagic shock and simulation 
non-intubation non-oxygenation situation; In both groups, performance measured with a 
checklist of treatment actions and non-technical skills measured with the Non-Technical 
Skills Scale for ANTS anesthesiologists was improved; without differences between both 
arms. However, no inference can be made from the population since this study has not been 
completed so far. 
In the Khoo and Collaborators essay(28)An educational intervention was conducted to fill 
gaps in medical knowledge and aid in decision-making with decision algorithms in 
outpatient institutions, that is, only one dimension of the HNT, in primary care institutions. 
The results are not applicable to medical crises since it was carried out in a different context 
and also the way of measuring the outcome, review of medical records, is aimed at 
detecting an adverse event, that is, the potential damage derived from the care of health 
and not medical error. 

In the study by Khan et al.(3. 4), only two specific dimensions of non-technical skills are 
included: assertive communication and teamwork; it was not possible to determine an 
overall reduction in medical error but a reduction in the risk of medical error with potential 
harm, a relative risk of 0.69 (95% CI 0.53 to 0.91) and an absolute risk reduction of 2% (95 
CI). % 1 to 4). 
The most important study on the reduction of medical error in crisis is that of Arriaga and 
Collaborators.(33) in which the use of checklists reduced the omission of simulation 
treatment steps with an absolute risk reduction of 17 and relative risk of 0.28 (95% CI). 0.18 
to 0.42). These checklists impact one dimension of the HNT: resource management. 
Later, in the study by Duclos et al.(31), no differences were found between MRC plus 
checklists versus checklists. This can be explained since the intervention, training in non-
technical skills, was carried out with two half-day days of discussion of CRM in crisis in the 
hospitals of this group, without using high-fidelity simulation, which is the standardized 
method for training. 
Therefore, there is uncertainty if training in non-technical skills can have an additional effect 
to checklists to decrease the incidence of medical error. 
Justification 
Although there are a wide variety of scenarios in which medical error occurs, the omission 
of treatment steps in medical crises is chosen as the outcome; firstly, due to the possible 
impact on mortality that its presence may have and; secondly, due to the high incidence of 
these errors in situations of very short time for decision-making. 
It has been described that, in the crisis scenario, the high cognitive and emotional load 
influences the correct decision making; on the other hand, the vulnerability of the patient 
in these situations limits the possibility of randomized clinical studies. Due to the ethical 
conflict that a study in medical crises has in real patients, the high-fidelity simulation 
scenario is chosen for this specific study. 
In addition to the ethical conflict, the high-fidelity simulation scenario is an ideal setting for 
measuring medical error due to the omission of treatment steps in medical crises. This due 
to the low frequency of these situations in real clinical scenarios, the possibility of making 
high-quality recordings of the scenarios; and that most non-technical skill measurement 
scales were designed and validated in high fidelity simulation(35). Additionally, it has been 
described that the perception of emotional charge in complex situations in simulation is 
similar to what happens in a real patient, even elevation of alpha amylase has been detected 
as a marker of stress in people subjected to high fidelity simulation.(36). 
Yuqi and collaborators in 2017 estimated in a controlled clinical trial that simulation training 
even in low fidelity, after a day of training in medical crises, increases the global score of 
non-technical skills measured with the Ottawa scale with mean differences between the 

Baseline and post-assessment value of 2.6 (95% CI, 1 to 4.3), with no differences between 
residency students and graduate professionals(37).  
Finally, as it is an educational strategy, the population that a priori benefits the most from 
these interventions is the personnel in training. In the case of the Faculty of Medicine of the 
University of Antioquia, the training of non-technical skills is not included in the micro 
curriculum of critical patient care, therefore, the results of the present study could be used 
to define modification or confirmation of the micro curriculum for critical patient care in 
the last semester of medicine. 
6b. Comparison justification. 
Until now, the use of checklists is the intervention that has the most empirical support in 
reducing medical error due to omission of steps in surgery (38). Arriaga et al. Found that 
the use of checklists reduces simulation crisis medical error with an absolute risk reduction 
of 17% and relative risk of 0.28. IC0.18 to 0.42; P <0.001(27). Finally, in the clinical trial by 
Duclos et al., In which checklists versus MRC training plus checklists were compared, a 
decrease in adverse event was shown in the two groups without differences between them, 
8⋅8 to 5⋅5% (OR 0.57, 95% CI 0⋅48 to 0.68) versus 7.9 to 5.4% in control (OR 0.64, 0.50 to 
0.81) (ROR 0.67 to 1.21)(31); the authors attribute the decrease in the probability of an 
adverse event to the application of checklists. 
In light of this, the checklist is the best strategy to prevent medical error in omitting steps 
in crisis, which is why the World Health Organization WHO recommends the use of 
checklists to reduce medical error in surgery. and medication error; and further 
recommends them as a primary educational component in patient safety competencies. 
Research question 
In the last semester medical students at the University of Antioquia, does training in non-
technical skills and checklists reduce simulation crisis medical error, compared to training 
with checklists? 
7. Objectives and Hypotheses 
Hypothesis 
 
In the last semester of medicine students at the University of Antioquia, training of non-
technical skills and checklists is superior compared to conventional training with checklists 
to decrease at least 10% omission of steps in crisis management medical in high fidelity 
simulation. 
Primary objective 
To determine if the training of non-technical skills and checklists in final semester students 
of medicine at the University of Antioquia is superior to conventional training with checklists 

to decrease at least 10% of omission of steps in the management of medical crisis in high 
fidelity simulation. 
 
Secondary Objectives  
Determine if there are differences between intervention and control strategies in the 
following results: 
 
Crisis resolution time  
 
Time in detection and discrimination of the crisis  
 
Overall score of non-technical skills  
 
Discriminated score between dimensions of non-technical skills  
 
Student satisfaction  
Incidence of inadequate crisis management  
 
8. Study design: 
TECRISIS is a study designed as a controlled clinical trial of superiority with parallel groups, 
random allocation and blinding of investigators who measure outcome. 
III Methods: participants, interventions and outcomes  
9. Description of the study characteristics 
 
Reference population: medical students  
 
Study population: final semester students of medicine at the University of Antioquia. 
This study will be carried out in Medellín Colombia, in a single center, the University of 
Antioquia. This center is chosen since it has a high fidelity simulation center, teachers 
with simulation experience and also has more than 100 medical students per semester. 
The community of students of the last semester of medicine is chosen since they are 
the population to which the possible results of the present study may have better 
application. Additionally, these interventions are educational strategies and could be 
adjusted or included in the institution's undergraduate medical curriculum program. 
 
10. Eligibility criteria  
10a. Inclusion criteria 
• Older than 18 years-old. 

• Final semester student of medicine at the University of Antioquia.  
• Have passed the theoretical knowledge exam for handling crisis events with a score 
of 100% 
• On-site availability for training days 
10b. Exclusion criteria 
• Have received training in a specific crisis resource management course. 
• Refusal to participate in the clinical study.  
11a. Interventions 
For all study participants: 
In order to increase homogeneity in the technical concepts prior to the interventions, all 
the participants will take a theoretical knowledge test to manage the events of the following 
crises: anaphylaxis, unstable bradycardia, cardiac arrest with defibrillable and non-
defibrillable rhythms, airway management failure, bronchospasm, severe bleeding, low 
blood pressure, hypoxia, and unstable tachycardia. 
The theoretical exam, with no limit of attempts, must be 100% passed. This will be designed 
by the main researchers and approved by a teacher external to the study. 
Protocol for the simulation sessions: based on the strategy of directed reflection, debriefing 
with good judgment, described by Maestre and collaborators(38); A safe container will be 
made, that is, the explanation of a series of agreements to generate confidence in the high-
fidelity simulation, by a teacher trained in directed reflection in all the simulation days, with 
ample and sufficient explanation to ensure the greatest student participation based on 
three principles. 
Denomination principle 1: fiction; both the researchers and the participants will commit to 
the best of their abilities to carry out the diagnoses and interventions as if it were a real 
patient; the simulation scenario will have physical fidelity, that is, spaces and sizes similar 
to real life. Emotional and psychological fidelity, that is, the same roles will be presented as 
in real practice; for example, treating doctor, nursing assistant and head of nursing to 
ensure that the perception of the situation is as close as possible to real life. 
Denomination principle 2: confidentiality; All the actions carried out in the simulation 
sessions, both training and outcome measurement, will only be discussed in the reflection 
space directed at the end of each simulation among the participants and will not be 
commented on in other scenarios. 
Denomination principle 3: basic principle; It will be verbally expressed that all the 
participants in the level of training in which they are considered to be competent, 
intelligent, who want to carry out the best actions to treat their patients and improve. 

After the agreement of the safe container, that is, the explanation of the three previous 
principles will proceed with the description of the clinical scenario of two of the crises 
described at random. After that, the reflection will be carried out to checklists or training of 
non-technical skills according to the group. 
Protocol for directed and structured reflection: directed reflection after the simulated crisis 
will last for a minimum of 30 minutes and a maximum of one hour, will consist of the 
following moments or phases: 
Phase 1: context description; After the simulation is finished, the participants will be 
transferred to the reflection room, a suitable and comfortable space different from the 
simulation. In this scenario, the phases of reflection will be described. 
Phase 2: emotional discharge; Participants will be asked about the emotions experienced in 
the simulation of the crisis, in order to reduce the emotional burden that may arise and in 
addition to using the possible mental models described to direct the reflection. 
Phase 3: discussion of reflection objectives: the objectives of the reflection will be described 
and agreed according to the intervention group, non-technical skills or checklists.  
Phase 4: discussion about mental models, conclusions and learning from the session; It will 
be done through the use of the “molecule” (38) as an investigation strategy in the reflection 
with good judgment in order to clarify the actions, concepts and mental models related to 
the assigned group. 
The exploration of mental models through the “molecule” strategy consists of the teacher 
or instructor, who uses the simulation with good judgment, carry out a directed dialogue to 
obtain an explanation by the student of an action committed in the simulation. This may be 
an error or a correct action, said explanation allows clarification or confirmation, by the 
teacher, of the concepts issued by the student. 
The “molecule” is an interrogation strategy that, based on trust between the student and 
the teacher, allows the search for the reasons why a particular action was carried out(38).  
For the intervention group 
Since the effectiveness of a single day of intervention to improve non-technical skills in work 
teams is controversial (39)(40), the specific training in non-technical skills with guided 
reflection structured in a 10-hour program is proposed. Two hours on the teleeducation 
platform that includes a description of non-technical skills and checklists, reflection 
exercises, a pre-test and a test at the end of the platform's content; and 8 face-to-face hours 
in high-fidelity simulation divided into two four-hour days with a minimum of three days 
apart, which will emphasize directed and structured reflection (structured debriefing) to 
mental models that are related to non-technical skills according to the previously described 
simulation protocol. 
The training will be carried out with four random crises from the list of the pathologies 
described, two in each session, this in order to avoid cognitive continuity bias. 

To achieve the adequate training of non-technical skills and that the participants acquire 
specific behaviors according to each dimension of the same, the directed and structured 
reflection will be carried out taking into account the following aspects:  
Leadership 
• Remain calm throughout the crisis 
• Make fast and safe decisions 
• Maintain global perspective by not focusing on specific skill and moving away from 
the crisis. 
Problem resolution 
• Fully and quickly apply systematic patient assessment 
• Always handle concurrently or simultaneously life-threatening problems 
• Aloud consider more likely alternatives during the crisis 
 
Situational awareness  
• Avoid cognitive bias of fixation technique 
• Reassess the situation by asking your team for information 
• Anticipate probable events constantly manifested as the request for resources that 
anticipate the evolution of the crisis 
Resource management 
• Prioritize tasks and assign them to your team 
• Ask for help early 
• Using checklists and other cognitive aids 
Communication 
• Always communicate clearly and concisely with the work team 
• Stimulate feedback of orders or cross check 
• Use directed verbal and nonverbal language 
 
That is, in each high-fidelity simulation, a constructive dialogue will be carried out with the 
structured debriefing protocol, to fulfill the actions directed at each dimension of non-
technical skills. 
To achieve the correct use of the checklist in crisis, directed and structured reflection will 
be carried out so that the participants acquire the following behaviors 
• Choosing the right list for the stage 
• Assignment of a specific participant using the checklist 

• Feedback to the work team on each action suggested in the checklist  
For the present protocol, the checklists in Spanish of the Colombian Society of 
Anesthesiology SCARE that are freely available will be used during the development of 
simulation crises.(41).  
For the control  
10 hour program; two hours on the teleeducation platform that includes a description of 
the checklists to be used, reflection exercises with a previous test and a test at the end of 
the contents of the platform focused on checklists; and 8 face-to-face hours in high-fidelity 
simulation divided into two four-hour days with a minimum of three days of difference 
between them, in which directed and structured reflection (structured debriefing) will be 
emphasized to the mental models that are related to the checklists. In crisis. 
The training will be carried out with four random crises from the list of the pathologies 
described, two in each session, this in order to avoid cognitive continuity bias.  
To achieve the correct use of the checklist in crisis, directed and structured reflection will 
be carried out so that the participants acquire the following behaviors 
• Choosing the right list for the stage 
• Assignment of a specific participant using the checklist 
• Feedback to the work team on each action suggested in the checklist  
For the present protocol, the checklists in Spanish of the Colombian Society of 
Anesthesiology SCARE that are freely available will be used during the development of 
simulation crises.(41).  
Recording for measurement of outcomes: 
The measurement of the outcomes described in section 18, will be carried out after 
completing the training, on a day different from the last simulation session. To guarantee 
the homogeneity of the treatment teams, each participant will be evaluated separately in a 
group of four people where three are resident doctors trained in non-technical skills and 
checklists blinded to the intervention, since they do not participate in the training sessions. 
, who will assume the roles of two nursing assistants and a circulator. 
Three crises will be carried out at random, different from those used in training to avoid 
cognitive continuity bias and will be recorded in the same simulation center for all 
participants with a Logitech® brand HD camera reference Pro stream C922 using a Jabra 
brand microphone ® reference Speak 510Ms. 
For all cases after recording for outcome measurement: 
As the intervention and control are about educational strategies of problem solving skills in 
medical crises, in simulated environments in students from the same year of training, from 

a single center, in which it is not possible to blind the participant, there may be 
communication between treatment and control groups.  
This possible communication can lead to biases that affect the internal validity of the study. 
First, compensatory rivalry bias, if the control group, in this case checklists, knows the 
outcome, they could behave differently to try to lessen the effect of the outcome on their 
group, responding to social competition. 
Second, demoralization bias, for the control group knowing that they would not receive the 
intervention training. 
To avoid these two possible biases, after recording the three crises to measure the 
outcome, all participants will undergo training corresponding to the other intervention arm 
to which they were initially assigned by means of protocol-directed reflection on non-skills. 
techniques for the control case or checklists for the intervention group case. Additionally, 
the platform of the arm opposed to the intervention will be left open to each participant. 
11b. Modification of the intervention 
As these are two educational strategies, no need for changes in the interventions is 
expected. 
11c. Strategies to improve adherence 
Various strategies will be used to improve adherence to the study protocol. 
Firstly, participants who agree to participate in the study will be explained the importance 
of fully complying with the intervention and control protocol, and the voluntary nature of 
participation will be emphasized.  
In addition, clinical internship rotations will be sought to ensure attendance at the three 
face-to-face sessions, two for training, one for outcome measurement, especially the 
course for critical patient care and the elective rotation for anesthesia for the last semester 
of medicine. It will seek support from the teachers who coordinate these rotations to 
achieve this goal.  
On the other hand, the virtual platform will have an easily developed content, which meets 
the objectives of standardizing the technical knowledge necessary for learning to carry out 
the intervention and control activities. The platform will be closely watched by one of the 
researchers to confirm the use of it by the participants. Lastly, the simulation center of the 
Faculty of Medicine of the University of Antioquia will be requested the appropriate spaces 
for interventions and recordings to measure the outcome, seeking to be separated from 
other training stations and thus ensure the comfort of the participants. . 
11d. Concomitant interventions 

As the teaching-learning relationship is bidirectional, other educational interventions on 
technical skills related to the scenarios and the resolution of questions and doubts about 
the technical concepts related to the platform will be allowed for both groups. 
No training will be conducted in either group on non-technical skills other than those 
contained in the training in this protocol.  
12. Outcomes  
12.1 Primary outcome: 
Difference of proportions of omission of steps to treatment by group, the measurement of 
this outcome will be made by reviewing the recordings of three random medical crises 
different from those used for training in each group of participants. The evaluation will be 
done by an independent collaborator blinded to the intervention group and previously 
trained in the detection of errors by one of the authors. Failure to apply the specific actions 
defined in each pathology, chosen by the authors according to Annex 1, will be considered 
as omission of the treatment step, this includes the maximum time determined for each 
action, the choice of appropriate medications with their respective doses, among others. 
Each evaluation is independent, each crisis will be evaluated in seven steps, 
12.2 Secondary outcomes: 
12.2a 1Difference of crisis resolution time averages in seconds between both groups, 
measured in the recording, taking as the beginning of the crisis the moment of calling the 
treatment team and the end when all the effective treatment of each crisis is completed , 
according to the treatment steps described in Annex 1. In the event that the treatment 
steps are not fully completed, the time will be measured until the end of the simulation. 
12.2b Difference of time averages in detection and discrimination of the crisis in seconds 
between both groups, taking as the beginning of the crisis the moment of calling the 
treatment team and the end the moment of explicitly requesting the specific checklist for 
the crisis or verbalize the diagnosis of the code situation. If the specific list is not requested 
or the diagnosis is not verbalized, the time until the end of the simulation will be counted. 
12.2c Mean difference between the global non-technical skills score measured with the 
Ottawa global scale based on video recording by an independent evaluator. 
12.2d Mean difference between the discriminated score between dimensions of the non-
technical skills of the two groups, measured with the Ottawa global scale based on video 
recording by an independent evaluator. 
Ottawa Global Scale Overview: this scale is free to use for research, it has a validation 
study in our environment, completed in the publication phase, its psychometric 
characteristics are summarized in Table 5 (42), the Spanish version can be seen in Annex 6. 
Table 5 Ottawa scale psychometric characteristics for HNT 

Dimension or item 
Internal 
consistency 
Reliability between 
ICC evaluators 
Reliability re-
test 
Construct validity 
Overall evaluation 
reference 
0.641 
0.761 
 
Leadership Skill 
0.902 
0.634 
0.808 
0,776 
Problem resolution 
0.915 
0.628 
0,779 
0.692 
Situational awareness 
0.930 
0.627 
0.708 
0.576 
Use of resources  
0.863 
0.696 
0.70 
0.578 
Communication skills  
0.893 
0.597 
0.7407 
0.872 
  
12.2e Student satisfaction:  
This exploratory outcome is chosen because of the importance of the perception of the 
participants that hypotheses could generate for future research. A search was made of 
validated and free scales for use without finding any that meets these requirements for 
high-fidelity simulation, therefore, the training satisfaction assessment format of the 
simulation center of the Faculty of Medicine of the University of Antioquia, format F-025-
08 (see annex 7). 
12.2f Incidence of inadequate crisis management: 
Difference in incidence of inappropriate management rating, this dichotomous rating will 
be performed by the blind evaluator of the outcomes, taking into account the treatment 
actions considered minimal by the researchers based on the different clinical practice 
guidelines, these are those specific to management by crisis, it will be classified as adequate 
management if it is met, inadequate management otherwise, according to table 6. 
Table 6. Minimum treatment actions for crisis resolution.  
Air embolism  
1. Stop the air intake site by applying 
irrigation  
2. Start dobutamine or norepinephrine if 
hypotension in less than 2 minutes  
3. Position in lateral decubitus on the 
affected side before 10 minutes 
Anaphylaxis  
1. Stop infusions 
2. Apply Adrenaline IM or IV in less than 2 
minutes 
3. Apply infusion epinephrine in case of 
non-response of 1 to 4 micrograms / 
minute 
Unstable Bradycardia 
1. Apply atropine 0.5mg IV repeat up to 
3mg total dose 
2. If bradycardia persists use 
transcutaneous pacemaker 
 

Cardiac arrest / Asystole (hypoxemia) 
1. Start cardiac massage in less than a 
minute 
2. Apply 1mg adrenaline every 3 to 5 
minutes 
3. Use of advanced airway device in less 
than 5 min 
Cardiac Arrest / Ventricular Tachycardia 
 
1. Start cardiac massage in less than 1 
minute 
2. Rhythm detection every 2 minutes 
3. Application of electric shock with 200J 
bipolar in less than 3 minutes 
Unanticipated difficult airway  
1. Apply FiO2 100% 
2. Perform minimum 3 laryngoscopies 
maximum 4 
3. Use second-generation supraglottic 
after laryngoscopy failure 
 
Hypovolemic shock from open trauma 
1. Verify the patency of 2 peripheral veins 
2. Administer 20ml / kilo bolus of 
crystalloids in less than 5 minutes 
3. Request Mass Transfusion Package 
Distributional shock hypotension  
1. Apply 20ml / kilo crystalloid bolus in the 
first 5 minutes 
2. Start norepinephrine at a dose of 0.05ug 
/ k / min in less than 5 minutes 
Malignant hyperthermia  
1. Apply Dantrolene at a dose of mg / kg in 
less than 5 minutes 
2. Suspend possible triggers of the crisis 
Foreign body airway obstruction  
1. Apply FiO2 100% 
2. Apply support with positive pressure 
ventilation in less than 4 minutes 
3. Manual removal of foreign body in less 
than 5 minutes 
  
Unstable ventricular tachycardia  
1. Cardiovert in synchronous mode with 
100 Joules in the first 3 minutes 
2. Perform second cardioversion with 150 
Joules in the first 5 minutes 
 
 
 

 
 
13. Figure 2: Participants timeline 
 
 
Final semester 
students 
Application of eligibility 
criteria (theoretical 
exam) 
Participant 
with exclusion 
criteria 
Random 
assignment 
Intervention 
group 
Control group  
Recording of 
outcome crisis 
Recording of 
outcome crisis 
Measurement 
of outcomes  
Losses 
N = 
Losses 
N = 
Losses 
N = 
Losses 
N = 
End of study 
Teaching the 
missing 
educational 
technique

Table 7. Follow-up program and procedures   
Reclu
Assign
Post-allocation stage  
Closing 
Time in days 
one 
one 2 3 4 5 6 7 8 9 
1
eleve
1
1
1
fiftee
1
Exercise 
Assignment  
Allocation screening  
Theoretical knowledge test 
Informed consent  
 
 
         
 
 
 
 
 
 
Assignment  
Intervention  
Post-test virtual platform 
HNT and LC training 
LC training  
Evaluations 
Baseline measurement 
Recording of outcome crisis 
 
 
         
 
 
 
 
 
 
Outcome measurement 
Measurement of secondary 
outcomes 
Reclu: Recruitment, Assig: Assignment.  
14. Sample Size 
The proportion of treatment steps and not the incidence of medical error is taken as the 
unit of analysis, the reason for this is the high incidence of medical error that can even 
manifest itself with more than one error due to crisis, therefore, if used the incidence of the 
event would decrease the sample size. 
Based on the study by Arraiga et al., The proportion of missed treatment steps in the 
expected control group is 26% and we consider a further 10% reduction in the intervention 
group to be clinically important. A minimum of 10% additional reduction in omitting 
treatment steps is decided because it is the approximate effect size of the other dimensions 
of non-technical skills other than resource management, a dimension that includes the use 
of checklists. It also establishes power of 90% and alpha of 0.05. 
The sample calculation is then carried out in the analysis unit omitting treatment steps 
according to the formula: 

 
With the statistical program R version 4.0.0 epiR statistical package, with the following 
code:  
> library (epiR) 
> epi.propsize (treat = 0.16, control = 0.26, n = NA, power = 0.9, design = 1, sided.test = 2, 
conf.level = 0.95) 
We found a sample size of 492 treatment actions per arm, which corresponds to 984 in 
total, and with an estimate of student losses of 20%, we found the total of 1,180 treatment 
actions; Since 21 treatment steps are evaluated in each team, we obtain a total of 56 final 
semester medical students, 28 in each arm. 
15. Recruitment 
In order to complete the calculated sample size, the following recruitment strategies will be 
carried out: 
• Explanation of the project at least once per internship cohort with the whole group. 
• Request for participation on day 1 of the anesthesiology rotation in boarding school 
and the care rotation of the critically ill patient. 
Table 8. Monthly evaluation of the monitoring status  
Recruitment month 
one 
2 
3 
4 
5 
6 
7 
8 
Current current income 
Income to date 
Income goal to date 
Real less projected 
Success ratio 
Projected final income 
Final deficit or excess 
 
IV Methods: allocation of interventions 
16a. Method to generate random sequence: with the statistical program R 4.0.0, a random 
sequence will be generated for both groups by blocks of 2 and 4 participants that will have 
a blind number for the researchers, in a 1: 1 ratio and without strata. The number of 
participants per block and the detailed randomization strategy will be carried out by an 
external research collaborator and will be kept hidden from the researchers. 

16b. Mechanism to hide the random sequence: the randomization mechanism will be kept 
hidden by opaque envelopes numbered consecutively and in the possession of an 
administrative assistant from the simulation center of the Faculty of Medicine of the 
University of Antioquia and only the group assigned to one will be revealed. of the 
researchers after signing the informed consent of the participant to place him in the 
respective group. 
16c. Implementation of the random sequence: an external collaborator will be in charge of 
generating the sequence and preparing the envelopes, researchers MZ and JPZ will be in 
charge of collecting the participants, revealing the opaque envelope in a row and assigning 
the participant to their respective group. 
17a. Masking. 
As these are two educational strategies that require verbalization as part of the training 
model based on feedback with good judgment, it is not possible or consistent to mask the 
intervention, both for the participants and for the researchers who apply the interventions. 
However, since it is a low-risk investigation, it is possible to mask the outcome to the 
participants. 
Trial participants: Tecrisis study participants will be aware of the interventions but will be 
blinded to the primary outcome, omission of treatment steps. This will be ensured with two 
strategies; first, modification of the title of the clinical trial taking into account only the 
secondary outcome of student satisfaction; Second, the directed reflections will focus on 
learning strategies and not on medical error. 
Intervention providers: the researchers who apply the intervention will not be blinded to it 
since they need to know the educational strategy to use.  
Outcome assessors: the collaborator who evaluates the outcomes will be blind to the 
interventions. At no time will the assigned group be revealed to him. 
Analysis of data: Researchers analyzing the data will not be blinded to interventions or 
outcomes and will not participate in outcome measurement.  
Data will not be presented masked to the external data monitoring committee.  
17b. Circumstances to reveal masking. 
It will be considered to reveal the masking of the outcome in the event that any of the 
participants present at the time of recording for the measurement of the outcome great 
psychological or emotional affectation by the simulation and the safe container described 
in the simulation methodology is not enough.  
V Methods: data collection, management and analysis.  
18. Baseline and outcome data collection plan 

Baseline characteristics: the following baseline characteristics of the participants in the first 
simulation session will be collected: age, sex, personal history of sleep disorders, personal 
history of mood disorders, hours of weekly care rotation, hours of daily sleep on average, 
reported simulation training hours, weekly work hours if applicable. On the day of the 
outcome measurement, the variable hours of sleep the day before the outcome 
measurement will be recorded. The variables to be registered are discriminated in Annex 5. 
These data will be filled out in physical form and will be transcribed in a database in Google 
documents.  
The outcome variables will be carried out electronically and are summarized in Table 8. 
Table 8 measurement of outcome variables 
Outcome 
Measurement  
Responsable 
Primary 
Skipping treatment steps  
Electronic format in Google 
based on video recording.  
Blind collaborator to the 
intervention  
Secondary 
Crisis resolution time  
Electronic format in Google 
based on video recording. 
Blind collaborator to the 
intervention 
Time 
in 
detection 
and 
discrimination of the crisis  
Electronic format in Google 
based on video recording. 
Blind collaborator to the 
intervention 
Overall score of non-technical 
skills  
Electronic format in Google 
based on video recording. 
Blind collaborator to the 
intervention 
Discriminated score between 
dimensions of non-technical 
skills  
Electronic format in Google 
based on video recording. 
Blind collaborator to the 
intervention 
Student satisfaction  
Electronic version of Format 
F-025-08 of the Simulation 
Center, Faculty of Medicine, 
University of Antioquia 
Self 
completed 
by 
the 
Student in an anonymous 
format. 
Incidence of inadequate crisis 
management 
Electronic format in Google 
based on video recording. 
Blind collaborator to the 
intervention 
 
18b. Plan to promote retention and complete follow-up 
The participation, retention and follow-up of the study will be voluntary, based on the 
explanation of the potential benefits in the participation of the study, such as training in 
high-fidelity simulation of both interventions, no financial remuneration will be used as a 
retention strategy.  
Since a minimum of three sessions participation on different days is required for high-
fidelity simulation training and outcome measurement, a possible participant loss of 20% is 
considered, which was included in the sample size calculation. 

The participant can withdraw from the study at any time they wish, even after 
randomization, this will be clarified from the beginning of the intervention and follow-up 
period, in addition it will not have repercussions on any qualification in any of the internship 
courses to be attended by the competitor. 
It will be carried out independently of the possible withdrawals from the study, analysis by 
intention to treat. 
19. Data handling: 
After completing the manual forms in their entirety, they will be subjected to quality control 
during the days of administration of the interventions, avoiding loss of data from the start 
of the study. After that, the central office of the present investigation located in the Faculty 
of Medicine of the University of Antioquia will be taken in an opaque and sealed envelope, 
where an administrative assistant with experience in electronic data management and 
investigation will enter the information from the formats. manuals to an electronic 
database that will have two backup copies and to which said assistant will only have access 
during data collection. Subsequently, they will be presented blinded to the researcher who 
will carry out the statistical analyzes described in the analysis plan. 
20 a. Analysis methods for primary and secondary outcomes. 
The baseline characteristics of the participants in both groups will be summarized with 
measures of frequency and proportions for the qualitative variables. In the case of 
quantitative variables, measures of central tendency and dispersion, mean and standard 
deviation or median and interquartile range will be used after performing the Shapiro Wilk 
normality test. 
The analysis of each variable is explained in Table 9, prior to the use of parametric tests, the 
necessary assumptions will be verified including probability distribution tests, 
independence of the data and equality of variances according to the case. For the ratio of 
proportions and mean differences of the groups, in case of non-compliance, non-parametric 
statistical inference will be made. 
To compare the intervention arm: training with non-technical skills and checklists with the 
control group: training with checklists, the proportion of omission of treatment steps per 
group will be used as the primary outcome variable. 
Alternate hypothesis: the difference in the proportion of omission of treatment steps 
between the control and intervention group is greater than 10%.  
Null hypothesis: the difference in the proportion of omission of treatment steps between 
the control and intervention group is 10% or less. 
Table 9 analysis plan by variable  

Outcome 
Outcome 
measure  
Statistical 
hypothesis  
Estimator  
Analysis 
method  
Primary 
outcome: 
Medical error 
Ratio 
of 
omission 
of 
treatment steps 
to total steps per 
group. 
Ha: Pcontrol 
- 
P 
intervention> 10% 
Ho: 
Pcontrol 
- 
Intervention = 10% 
Difference 
in 
proportions 
(95% CI) 
Chi square test  
Overall score on 
non-technical 
skills scale 
Average Interval 
per 
group 
between 1 to 45 
He 
has: 
μintervention>μcontrol 
Ho: 
μintervention≤ 
μcontrol 
 
Mean 
difference (95% 
CI)  
T Student test.  
Ottawa 
Leadership 
on 
Scale 
Average Interval 
per 
group 
between 1 and 7 
He 
has: 
μintervention>μcontrol 
Ho: 
μintervention≤ 
μcontrol 
Mean 
difference (95% 
CI)  
T Student test.  
Ottawa 
scale 
problem solving 
Average Interval 
per 
group 
between 1 and 7 
Average 
Interval 
per group between 
1 and 7 
Mean 
difference (95% 
CI)  
T Student test.  
Situational 
awareness 
on 
the Ottawa scale 
Average Interval 
per 
group 
between 1 and 7 
He 
has: 
μintervention>μcontrol 
Ho: 
μintervention≤ 
μcontrol 
Mean 
difference (95% 
CI)  
T Student test.  
Utilization 
of 
Ottawa 
scale 
resources 
Average Interval 
per 
group 
between 1 and 7 
He 
has: 
μintervention>μcontrol 
Ho: 
μintervention≤ 
μcontrol 
Mean 
difference (95% 
CI)  
T Student test.  
Ottawa 
Scale 
Communication 
Average Interval 
per 
group 
between 1 and 7 
He 
has: 
μintervention>μcontrol 
Ho: 
μintervention≤ 
μcontrol 
Mean 
difference (95% 
CI)  
T Student test.  
Crisis resolution 
time  
Average time in 
minutes 
per 
group 
He has: μintervention< 
μcontrol 
Ho: 
μintervention≥ 
μcontrol 
Mean 
difference (95% 
CI)  
T Student test.  
Time 
in 
detection 
and 
discrimination of 
the crisis  
Average time in 
minutes 
per 
group 
He has: μintervention< 
μcontrol 
Ho: 
μintervention≥ 
μcontrol 
Mean 
difference (95% 
CI)  
T Student test.  
Student 
satisfaction 
Difference 
of 
excellent 
assessment 
proportions in 
the categories 
of the format F-
025-08 
Ha: 
Pintervencion> 
Pcontrol 
Ho: Pintervencion = 
Pcontrol 
Difference 
of 
proportions. 
(95% CI) 
Fisher's Exact 
Test. 

Incidence 
of 
improper 
handling  
Relative 
risk 
inadequate 
management 
intervention / 
control  
Ha: RR ≠ 1 
Ho: RR = 1 
Relative 
Risk 
(95% CI)  
  
Chi square test.  
 
 
20b. Additional analysis methods 
Other analyzes by subgroups or adjustment of analysis by other variables will not be 
considered.  
20c. Methods for analysis of censored or missing data 
In case of censored or lost data, multiple imputation method will be carried out (43).  
VI Methods: data monitoring  
21a. Composition of the data monitoring committee 
The Tecrisis study will have a data monitoring committee external to the research group, 
which will be made up of the coordinator of the simulation center of the Faculty of Medicine 
of the University of Antioquia, a clinical simulation teacher from outside the study, and a 
researcher from the research group. GRIMPA Research in Perioperative Medicine. 
21b. Interim Analysis Description 
An interim analysis will be carried out with 50% of the participants collected, blind and 
foreign to the research group, only for adverse events in the case suggested by the data 
monitoring committee.  
22. Damage  
Given that it is an educational study that uses the same strategies that are usually used in 
the training of participants, no adverse events are expected other than a possible emotional 
affectation due to the high fidelity simulation. The report and management of this will be 
done according to the institutional protocol of the simulation center of the Faculty of 
Medicine of the University of Antioquia. However, this study is low risk since the 
participants are constantly exposed to simulation as a teaching tool and reaching an 
adequate degree of stress can improve learning even in this scenario. 
Other unforeseeable adverse events within this protocol will be reported in case of 
presenting to the simulation center of the Faculty of Medicine of the University of Antioquia 
and to the ethics committee of the same institution. 
Any non serious adverse event will be recorded and evaluated according to the following 
characteristics: expected / unexpected, severity, possible cause, management and outcome. 

23. Audit 
An audit of adherence to the protocol is proposed by the data monitoring committee once 
a semester, regardless of the percentage of the sample collected. 
VII Ethics and dissemination  
24. Approval by ethics committee  
This protocol and informed consent will be evaluated and submitted for approval by the 
ethics committee of the Faculty of Medicine of the University of Antioquia.  
We consider that it complies with the seven recommendations of the American Medicine 
Association(44). 
1. Social or scientific value: this section is fulfilled since a clinical study is proposed that can 
improve health results and possibly provide tools or confirm existing tools to reduce 
medical error due to the omission of treatment crises. In addition to increasing knowledge 
of non-technical skills and checklists that could improve the satisfaction of students in the 
medicine program at the University of Antioquia. 
2. Scientific validity: the principles and methods including statistical analyzes are proposed 
based on the recommendations of the Master of Clinical Epidemiology of the University of 
Antioquia with the aim of resulting in valid and reproducible data. 
3. Fair selection of subjects: the selection of the participants does not generate any 
vulnerability, on the contrary, they could contribute to the training process as medical 
professionals. Participation in this study does not lead to risks of social stigmatization. In 
addition, as a matter of justice, it is proposed after recording for the outcome measurement 
to carry out the two intervention and control training sessions for the two groups. 
4. Adequate risk-benefit ratio: given the simulation methodology as a tool for the 
administration of the intervention and control, based on good judgment, the risks of 
adverse events are minimized, which are similar to those of any simulation teaching 
scenario. Among the potential benefits is increasing exposure to medical crisis resolution 
training with the goal of reducing medical error. 
5. Independent review: This protocol has two independent and blind review times. A first 
moment by two professors of the Master of Clinical Epidemiology at the University of 
Antioquia and a second moment with two independent pairs. 
6. Informed consent: ample and sufficient information will be provided for informed 
consent in which the interventions, the potential risks, benefits and alternatives are 
explained. 
7. Respect for potential and enrolled participants: this recommendation is met since 
participants can withdraw at any time from the study without any summative or formative 
retaliation, privacy of all participants is protected, participants will be informed in case of 
new information and a constant monitoring of adherence to the protocol will be carried 

out. In addition, it is a low-risk study that complies with the recommendations of the World 
Health Organization for clinical studies in humans.(Four. Five) and with the ethical principles 
of respect for people, justice and charity manifested in the Declaration of Helsinki and the 
Belmont Report. 
It also complies with the recommendations of the ministry of social protection in Colombia 
expressed in resolutions 8430 of 1993(46) and 2778 of 2008 of good clinical practices(47).  
25. Modifications to the protocol  
In the event that there is any modification to this protocol that impacts the conduct of the 
study, for example, the potential benefit of the interventions in the participants, the 
objectives, the design, the population or the sample size, a formal correction will be made 
of the protocol, will be presented to the ethics committee of the University of Antioquia 
and will be implemented after its approval. For administrative corrections that do not 
generate changes in the conduct of the study, notification will be made to the ethics 
committee without formal protocol change. 
26. Informed Consent  
 
Informed consent will be obtained from the participants eligible for the present study, from 
one of the researchers who does not participate in the summative evaluation of the clinical 
rotations, this in order not to generate possible pressure on the participants, the potential 
benefits of the two educational interventions and the expected results. A benefit of 
participating in the study is that it includes three simulation days in addition to the standard 
undergraduate curriculum training. Possible adverse effects such as emotional impairment 
will be explained and authorization will also be requested for the use of the data generated 
from this research in other research protocols. Informed consent can be seen in its entirety 
in Annex 2. 
27. Confidentiality  
All the information on paper related to the study will be protected in the simulation center 
of the Faculty of Medicine of the University of Antioquia, the digital information will be 
protected in a computer with a password and also one of the researchers will have a backup 
hard disk with all the information that will also have a login password. 
The forms filled out on the Google Docs platform will be protected by institutional mail with 
a password known by the administrative assistant who files them and the researcher who 
will analyze them.  
The videos made for the outcome measurement will be stored on a computer with a 
password and also one of the researchers will have a backup hard disk with all the 
information that will also have a login password, the collaborators who measure the 
outcome will have access to said videos at the time of such measurement. 
28. Declaration of conflict of interest  

The present principal investigators do not have any conflict of interest regarding the two 
interventions that will be carried out.  
29. Access to data 
During the clinical trial, the collaborators who perform the outcomes will not have access 
to the data, the main researchers will not have access to the database until the end of the 
study to avoid loss of blinding.  
Researchers will have access to the complete database only at the time of results analysis.  
Participants will have access to the personal data of the study once their analysis has been 
completed, and the database will also be restricted to avoid any information that would 
allow the patient to be identified.  
30. Post-study care 
Study participants will continue with their clinical internship rotation with the same 
academic, evaluative and hourly intensity as students who do not participate in the study, 
no financial compensation will be made for participation in this clinical trial, nor will 
pharmacological interventions be performed. or that differ from traditional exposure to the 
high fidelity simulation, low risk of the presence of adverse effects derived from the 
intervention is expected. 
31. Dissemination policy 
31a. Communication plan of the results: it is intended to communicate the results of the 
present study in different media: 
Publication of the main article: the results of this study will be taken to an indexed and 
homologated journal by Colciencias, even in case of no differences between the groups, 
there are also no limitations on the part of the financing entities of this study for publication. 
Publication of minor article: possible secondary articles derived from this study will be 
submitted to publication in journals indexed and approved by Colciencias, the authors will 
be those who design new research questions that can be answered with the possible 
assembled basis of this study. 
31b. Authorship Plan: the authors of the possible publications of this study will be those 
who meet the criteria required by the different scientific journals, this includes, but is not 
limited to: patient collection, protocol design, data analysis and final writing . It is not 
intended to hire professional writers for possible publications, although it is possible for 
style editing. 
31b. Public Protocol Access Plan: the protocol will be published on clinicaltrials.gov and in 
its full version it will be published on the anesthesiology platform of the University of 
Antioquia on the teleeducacionmedicina.udea.edu.co page. 
 

 
 
 
 
 
 
 
 
 
VIII Annexes 
Annex 1: List of medical crises with their corresponding treatment steps. 
Air Embolism  
1. Declare the crisis  
2. Request Help in less than 1 minute  
3. Apply FiO2 100% 
4. Stop the air intake site by applying 
irrigation  
5. Request echocardiography 
6. Start dobutamine or norepinephrine if 
hypotension in less than 2 minutes  
7. Position in lateral decubitus on the 
affected side before 10 minutes 
Anaphylaxis  
1. Declare the crisis 
2. Request help in less than 1 minute  
3. Apply FiO2 100% 
4. Stop infusions 
5. Apply IM or IV adrenaline in less than 2 
minutes  
6. Apply infusion epinephrine in case of 
non-response of 1 to 4 micrograms / 
minute 
7. Apply Hydrocortisone 100-200mg IV 
within 10 minutes  
Unstable Bradycardia 
1. Declare the crisis  
2. Request Help in less than 1 minute  
3. Apply FiO2 100% 
4. Apply atropine 0.5mg IV repeat up to 
3mg total dose  

5. Use adrenaline 2ugr / min after atropine 
failure until capture of transcutaneous 
pacemaker 
6. If bradycardia persists use 
transcutaneous pacemaker  
7. Increase 10mA until presence of pulse  
 
Cardiac arrest / Asystole (hypoxemia) 
1. Declare the crisis  
2. Request Help in less than 1 minute  
3. Apply FiO2 100% 
4. Start cardiac massage in less than 1 
minute 
5. Apply 1mg adrenaline every 3 to 5 
minutes  
6. Rhythm detection every 2 minutes  
7. Placement of advanced airway device 
less than 5 minutes 
Cardiac Arrest / Ventricular Tachycardia 
 
1. Declare the crisis  
2. Request Help in less than 1 minute  
3. Apply FiO2 100% 
4. Start cardiac massage in less than 1 
minute 
5. Apply 1mg adrenaline every 3 to 5 
minutes  
6. Rhythm detection every 2 minutes 
7. Application of electric shock with 200J 
bipolar in less than 3 minutes 
Unanticipated difficult airway  
1. Declare the crisis  
2. Request Help in less than 1 minute  
3. Apply FiO2 100% 
4. Perform minimum 3 laryngoscopies 
maximum 4  
5. Use second-generation supraglottic 
after laryngoscopy failure  
6. Stop airway interventions after rescue 
with supraglottic  
7. Application of neuromuscular relaxant 
at full dose (rocuronium 1.2 mg / kg dose 
or succinylcholine at 1.5mg IV)  
Hypovolemic shock from open trauma 
1. Declare the crisis  
2. Request Help in less than 1 minute  
3. Apply FiO2 100% 
4. Verify the patency of 2 peripheral veins 

5. Administer 20ml / kilo bolus of 
crystalloids in less than 5 minutes 
6. Request bulk transfer package 
7. Repeat 20ml liquid bolus / crystalloid 
thread 
Distributional shock hypotension  
1. Declare the crisis  
2. Request Help in less than 1 minute  
3. Apply FiO2 100% 
4. Apply 20ml / kilo crystalloid bolus in the 
first 5 minutes 
5. Start norepinephrine at a dose of 0.05ug 
/ k / min in less than 5 minutes 
6. Request vital signs monitoring every 5 
minutes 
7. Verify patency of 2 venous accesses 
Malignant hyperthermia  
1. Declare the crisis  
2. Request Help in less than 1 minute  
3. Apply FiO2 100% 
4. Apply Dantrolene at a dose of mg / kg in 
less than 5 minutes 
5. Increase ventilatory minute volume to 
10L / min 
6. Suspend possible triggers of the crisis 
7. Apply topical cooling measures 
Foreign body airway obstruction  
1. Declare the crisis  
2. Request Help in less than 1 minute  
3. Apply FiO2 100% 
4. Apply support with positive pressure 
ventilation in less than 4 minutes 
5. Manual removal of foreign body in less 
than 5 minutes 
6. Indicate safety position in right lateral 
decubitus after removal of foreign body 
7. Assess consciousness using the Glasgow 
scale application. 
Unstable ventricular tachycardia 
1. Declare the crisis  
2. Request Help in less than 1 minute  
3. Apply FiO2 100% 
4. Request stop car in less than 1 minute 
5. Cardiovert in synchronous mode with 
100 Joules in the first 3 minutes 
6. Perform second cardioversion with 150 
Joules in the first 5 minutes  

7. Request control electrocardiogram after 
return to sinus rhythm 
  
 
 

Annex 2 Informed consent form 
INFORMED CONSENT FOR PARTICIPATION IN CLINICAL RESEARCH PROTOCOLS FACULTY OF 
MEDICINE UNIVERSIDAD DE ANTIOQUIA 
 
 
Project title: Non-technical skills training and checklists versus standard training with checklists in 
boarding school students, randomized controlled clinical trial. 
 
 
Name: Mario Andrés Zamudio Burbano 
Address: Calle 64 # 51D 154  
Telephones: 5167469 - 44441333 ext. 3326 
Email: mario.zamudio@udea.edu.co  
Place of work: Anesthesia Service - University of Antioquia  
Site where the study will be carried out: simulation center, Faculty of Medicine, University of 
Antioquia.  
Entities that support the research: University of Antioquia  
Research sponsoring entity: None  
Mr. Participant: You are being invited to participate in an investigation into the best simulation 
educational strategy. Firstly, the use of checklists that are aids for doctors to make decisions in 
different contexts, are currently considered the best strategy. Secondly, training in checklists and 
non-technical skills, which also includes communication, leadership, role management, among 
other strategies. 
In principle, the study will not change the training objectives of your rotation of the last semester of 
medicine, the same planned scenarios are used for your training with the same simulation tools. 
What is intended to be evaluated in this study is training on checklists and more training in non-
technical skills is superior to training with checklists only, for internship students. In any case, at the 
end of the study you will receive both trainings. 
Study procedures.  
After agreeing to participate in the research, you will be randomly assigned to one of the two 
research groups. Randomly it is like tossing a coin, if it falls heads, you will be assigned to the training 
group on non-technical skills and checklists, if seal falls you will be assigned to the training group on 
checklists; In either case, after completing the study you will receive both trainings. 

Participation in this research does not carry great risks and uses educational tools similar to those 
of your scheduled clinical rotation.  
Research risks  
Your admission to this study is completely voluntary, as well as the option of withdrawal at any time. 
The data or all the information obtained from you, such as your name, the ID number, the age and 
what the researchers write down will be hidden from all people who are not involved in the 
investigation, that is, they will be kept strictly confidentiality. Participation does not mean any 
additional expense for you other than time. 
Study alternatives. If you decide not to participate in the study, this will have no impact on your 
current rotation, neither training nor evaluation. If you initially decide to participate in the study 
and eventually decide to withdraw from it, it will not have any repercussions either. 
Participant benefits. Your participation in the study will not receive any type of financial 
compensation, however, it would have the benefit of receiving non-technical skills training and 
checklists that can benefit your professional practice. Their participation will allow it to be verified 
if the use of a new educational tool is really useful and effective, which could benefit other students 
in the same level of training in the future, if it is shown that the new method is superior to the 
conventional one. 
Apart from the inconvenience of the time it takes to read this document and decide voluntarily to 
participate, there are other additional commitments.  
Participant's commitments  
1. Participate in all virtual platform activities that takes approximately 2 hours. 
2. Participate in all simulation activities that take 8 hours. 
3. Inform any of the researchers or the ethics committee of the Faculty of Medicine of any damage 
or adverse event that may arise.  
The researcher assumes the following commitments:  
1. Follow up throughout the process. 
2. Be pending and solve the problems that arise during the study period.  
3. Answer and clarify any questions about the procedures, risks, benefits and other matters related 
to the investigation.  
4. Request the evaluation by the respective specialists or services you need in case of any adverse 
event.  
5. Keep the data of the participants hidden from personnel who are not related to the research, that 
is, confidentiality.  
6. The research is duly approved by the bioethics committee of the Faculty of Medicine of the 
University of Antioquia. It will also be duly registered in the University Research System of the 
University of Antioquia and in the International Database of Clinical Trials (Clinicaltrials.gov). The 

researchers are medical graduates from certified universities with valid registration to practice the 
profession and work as teachers at the institution. 
7. Disclose the results of the investigation once it is completed.  
8. Provide real-time information on the status of the study.  
9. Disseminate the results and conclusions among all the participants. 
The fact of signing this document does not imply the waiver of the legal rights that may exist.  
Expected results  
The results will be published in a magazine that reaches teachers or doctors from different parts of 
the world to achieve a more effective and safe practice and medical education. These results will 
serve to take advantage of new educational resources in the training of health professionals who 
can provide greater safety and quality to the care of their patients. The dissemination of the results 
may lead to the widespread use of these techniques in the population with benefits and reduced 
risks. 
People to contact for information  
Name: Mario Andrés Zamudio Burbano, Address: Calle 64 # 51D 154 Telephones: 5167469 - 
44441333 ext. 3326 Email:mario.zamudio@udea.edu.co. Place of work: Anesthesia service - 
University of Antioquia. Contact Ethics Committee Faculty of Medicine, University of Antioquia. 
 
Acceptance of participation in the Study  
I, __________________________________________________, with citizenship card number 
__________________ of________________, confirm that I have read, the information for the 
previous study has been explained to me and that I have had the opportunity to ask questions and 
they have been solved. I understand that my participation is voluntary and that I am free to 
withdraw at any time without giving any explanation, without my academic training or legal rights 
being affected. I understand that the study researchers, the institutional ethics committee and the 
judicial authorities will be the only people who will be able to observe the recordings collected in 
the study. I agree to the collection, processing, 
I agree to participate in the study described above.  
Firm: __________________________________________  
Date:  
 
Principal investigator or who requests consent:  
Name:  
Firm: __________________________________________  

Date:  
Witness 1  
Name:  
Relationship with the participant:  
Residence address:  
Firm: __________________________________________ 
Date:  
Witness 2  
Name: Relationship with the participant:  
Residence address:  
Firm: ___________________________________________  
Date: 
 
 
 

Annex 3 Schedule of activities 
Exercise 
Responsable 
2019 
2020 
2021 
8 9 
1
0 
eleve
n 
1
2 
on
e 2 3 4 5 6 7 8 9 
1
0 
eleve
n 
1
2 
on
e 2 3 4 5 6 7 8 
Literature 
Review 
Investigator 
Preparation 
and 
Completion 
of the 
research 
protocol. 
Investigator 
 
 
Presentatio
n of the 
Research 
Protocol 
Postgraduat
e 
Committee. 
Graduate 
Committee 
Researcher 
Presentatio
n and 
evaluation 
of the 
protocol by 
external 
peers. 
External 
Peer 
Investigator 
Presentatio
n of the 
institutional 
ethics 
committee 
protocol. 
HUSVF 
Ethics 
Committee 
Researcher 
Suggested 
protocol 
modificatio
ns 
Investigator 
Sample 
Collection. 
Investigatio
n Group. 
Data 
analysis. 
Principal 
investigator 
Interpretati
on of 
results. 
Principal 
investigator 
Preparation 
of the text 
for 
publication. 
Investigate 
Main 
Presentatio
n of Results 
to the 
Group of 
Principal 
Investigator 
of the 
Clinical 

Clinical 
Epidemiolog
y. 
Epidemiolo
gy Group 
Study 
evaluation 
by external 
peers. 
External 
Pairs 
Publication 
process. 
Principal 
investigator 
 
 
 

Annex 4 Global budget  
Heading 
Sources  
Total  
Simulation Center  
Research group  
Personal 
 250,000,000  
 250,000,000  
Equipment 
 -  
materials 
 8,850,000  
 8,850,000  
Field trips 
 -  
 -  
 -  
Bibliographic material 
 500,000  
 500,000  
 1,000,000  
Publications  
 3,000,000  
 3,000,000  
Technical services 
 100,000  
  
100,000  
Travels 
 -  
buildings 
 -  
 -  
 -  
Maintenance 
 -  
 -  
 -  
Total 
 262,950,000  
Numbers in colombian pesos 
Annex 5: Table of variables 
Variable Operational definition 
Nature 
Scale  
Unit or code 
X 1 
Age 
Continuous 
quantitative 
Reason  
Years  
X 2 
Sex 
Qualitative 
Nominal 
1. woman, 2. 
man 
X 3 
Personal history of sleep disorders  
Qualitative 
Nominal 
0. no, 1. yes 
X 4 
Personal history of mood disorders 
Qualitative 
Nominal 
0. no, 1. yes 
X 5 
Hours of weekly care rotation  
Continuous 
quantitative 
Reason  
Hours 
X 6 
Weekly working hours 
Continuous 
quantitative 
Reason  
Hours  
X 7 
Hours of sleep the day before 
measurement outcome 
Continuous 
quantitative 
Reason  
Hours  
X 8 
Average daily sleep hours 
Continuous 
quantitative 
Reason  
Hours 
X 9 
Self-reported hours of simulation 
training 
Continuous 
quantitative 
Reason  
Hours 
X 10 
Failure rate of treatment steps  
Continuous 
quantitative 
Reason  
Percentage  
X 11 
Overall score on non-technical 
skills scale 
Discrete 
quantitative  
Interval 
1 to 7 
X 12 
Ottawa Leadership on Scale 
Discrete 
quantitative  
Interval 
1 to 7 
X 13 
Ottawa scale problem solving 
Discrete 
quantitative  
Interval 
1 to 7 

X 14 
Situational awareness on the 
Ottawa scale 
Discrete 
quantitative  
Interval 
1 to 7 
X 15 
Utilization of Ottawa scale 
resources 
Discrete 
quantitative  
Interval 
1 to 7 
X 16 
Ottawa Scale Communication 
Discrete 
quantitative  
Interval 
1 to 7 
X 17 
Crisis resolution time  
Continuous 
quantitative 
Reason  
minutes 
X 18 
Time in detection and 
discrimination of the crisis  
Continuous 
quantitative 
Reason  
Minutes 
X 17 
Inadequate crisis management  
Qualitative  
Nominal 
0. no, 1. yes 
 Variables of the satisfaction format 
X 18 
Mastery of course topics 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 19 
Exhibition security 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 20 
Clear and accurate answers to 
questions 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 21 
Ability to arouse interest 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 22 
Efficiency in the use of class time 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 23 
Order, coherence and clarity in the 
presentation of the topics 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 24 
Punctuality and attendance at class 
sessions 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 25  
Importance of the workshop 
course in daily practice 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 26 
Interest and topicality of the 
course-workshop content 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 

3. Excellent  
X 27 
Achievement of the objectives 
formulated in the course-workshop 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 28 
Practical workshops 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 29 
Convenience of Hourly intensity 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 30 
Quantity of equipment used 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 31 
Quality of the equipment used 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 32 
Installations 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 33 
Access to the teleeducation 
platform 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 34 
Ease in the use of the tele-
education platform 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
X 35 
Contribution to the course of study 
material located on the tele-
education platform 
Qualitative 
Ordinal  
0. Poor 
1. Acceptable 
2. good 
3. Excellent  
 
 
 

Annex 6. Ottawa Global Scale Spanish version  
 

References  
one.  MD LLL. Error In medicine. Jama. 1994; 272 (23): 1851–7. 
2.  
Makary MA, Daniel M. Medical error-the third leading cause of death in the US. 
BMJ [Internet]. 2016; 353 (May): 1–5. Available from: 
http://dx.doi.org/doi:10.1136/bmj.i2139 
3.  
N PM. Medical error and adverse events. 2008; 79 (3): 319–26. 
Four.  Aranaz-Andrés JM, Aibar-Remón C, Limón-Ramírez R, Amarilla A, Restrepo FR, Urroz 
O, et al. Prevalence of adverse events in the hospitals of five Latin American 
countries: Results of the “Iberoamerican study of adverse events” (IBEAS). BMJ 
Qual Saf. 2011; 20 (12): 1043–51. 
5.  
Eslava-schmalbach J, Santofimio-sierra D, Altahona H. Incidence and Avoidability of 
Adverse Events in Hospitalized Patients in three Hospital Institutions in Colombia, 
2006. 2008; 10 (2): 215–26.  
6.  
Rothschild JM, Landrigan CP, Cronin JW, Kaushal R, Lockley SW, Burdick E, et al. The 
Critical Care Safety Study: The incidence and nature of adverse events and serious 
medical errors in intensive care *. 2005; 33 (8). 
7.  
Kemper PF, Bruijne M De, Dyck C Van, So RL, Tangkau P, Wagner C. Crew resource 
management training in the intensive care unit. A multisite controlled before - after 
study. 2016; (February): 1–11. 
8.  
Flannery AH, Parli SE. Medication errors in cardiopulmonary arrest and code-related 
situations. Am J Crit Care. 2016; 25 (1): 12–20. 
9.  
1995 Incidence of adverse drug events and potential adverse drug events. 
Implications for prevention. ADE Prevention Study Group.pdf. 
10.  
Norman GR, Monteiro SD, Sherbino J, Ilgen JS, Schmidt HG, Mamede S. The Causes 
of Errors in Clinical Reasoning: Cognitive Biases, Knowledge Deficits, and Dual 
Process Thinking. Acad Med. 2017; 92 (1): 23–30. 
eleven.  
Pace WD, Fernald DH, Harris DM, Dickinson LM, Araya-guerra R, Staton EW, 
et al. Developing a Taxonomy for Coding Ambulatory Medical Errors: A Report from 
the ASIPS Collaborative. : 1–8. 
12.  
Article O. A preliminary taxonomy of medical errors in family practice. 2002; 233–8. 
13.  
Zhang J, Patel VL, Johnson TR, Shortliffe EH. A cognitive taxonomy of medical errors. 
2004; 37: 193–204. 
14.  
Krage R, Tjon Soei Len L, Schober P, Kolenbrander M, Van Groeningen D, Loer SA, et 
al. Does individual experience affect performance during cardiopulmonary 
resuscitation with additional external distractors? Anesthesia. 2014; 69 (9): 983–9. 
fifteen.  
Lipshutz AKM, Morlock LL, Shore AD, Hicks RW, Dy SM, Pronovost PJ, et al. 

Medication Errors Associated with Code Situations in US Hospitals: Direct and 
Collateral Damage. Jt Comm J Qual Patient Saf [Internet]. 2008; 34 (1): 46–56. 
Available from: http://dx.doi.org/10.1016/S1553-7250(08)34007-0 
16.  
Textor J, Zander B Van Der, Gilthorpe MS. Robust causal inference using directed 
acyclic graphs: the R package 'dagitty.' 2017; (January): 1887–94. 
17.  
Uramatsu M, Fujisawa Y, Mizuno S, Souma T, Komatsubara A, Miki T. Do failures in 
non-technical skills contribute to fatal medical accidents in Japan? A review of the 
2010-2013 national accident reports. BMJ Open. 2017; 7 (2): 1–7. 
18.  
Cook T (Anaesthetist), Woodall N (Consultant anaesthetist), Frerk C, Royal College 
of Anaesthetists (Great Britain), Difficult Airway Society (Great Britain). Major 
complications of airway management in the United Kingdom: report and findings: 
4th National Audit Project of the Royal College of Anaesthetists and the Difficult 
Airway Society: NAP4. 216 p. 
19.  
Panesar SS, Carson-stevens A, Mann BS, Bhandari M, Madhok R. Mortality as an 
indicator of patient safety in orthopedics: lessons from qualitative analysis of a 
database of medical errors. 2012; 
twenty.  
Hull L, Arora S, Aggarwal R, Darzi A, Vincent C, Sevdalis N. The impact of 
nontechnical skills on technical performance in surgery: A systematic review. J Am 
Coll Surg [Internet]. 2012; 214 (2): 214–30. Available from: 
http://dx.doi.org/10.1016/j.jamcollsurg.2011.10.016 
twenty-one.  Krage R, Zwaan L, Tjon Soei Len L, Kolenbrander MW, Van Groeningen Di, 
Loer SA, et al. Relationship between non-technical skills and technical performance 
during cardiopulmonary resuscitation: Does stress have an influence? Emerg Med J. 
2017; 34 (11): 728–33. 
22.  
Flin R, Martin L, Goeters KM, Hörmann HJ, Amalberti R, Valot C, et al. Development 
of the NOTECHS (non-technical skills) system for assessing pilots' CRM skills. Hum 
Factors Aerosp Saf. 2003; (January): 97–119. 
2. 3.  Berner, Juan Enrique. Ewrtz E. Importance of non-technical skills in current surgical 
practice. Spanish Surgery. 2019; 7: 5–10. 
24.  
Topcu I, Türkmen AS, Sahiner NC, Savaser S, Sen H. Physicians 'and nurses' medical 
errors associated with communication failures. 2010; 67 (4): 600–4. 
25.  
Catchpole K, Mishra A, Handa A, Mcculloch P. Teamwork and Error in the Operating 
Room. 2008; 247 (4): 699–706. 
26.  
Thomas EJ, Taggart B, Crandell S, Lasky RE, Williams AL, Love LJ, et al. Teaching 
teamwork during the Neonatal Resuscitation Program: a randomized trial. 2007; 
(January): 409–14. 
27.  
Müller MP, Hänsel M, Fichtner A, Hardt F, Weber S, Kirschbaum C, et al. 

Excellencein performance and stress reduction during two different full scale 
simulator training courses: A pilot study ଝ , ଝଝ. 2009; 80: 919–24. 
28.  
Khoo EM, Sararaks S, Lee K, Medicine MF, Liew SM, Samad AA, et al. Reducing 
Medical Errors in Primary Care Using a Pragmatic Complex Intervention. 2010; 
29.  
Tam P, Nijjar AP, Fok M, Little C, Shingina A, Bittman J, et al. Structured patient 
handoff on an internal medicine ward: A cluster randomized control trial. N Engl J 
Med. 2018; 1–12. 
30.  
Wetmore D, Goldberg A, Gandhi N, Spivack J, Mccormick P, Jr SD. An embedded 
checklist in the Anesthesia Information Management System improves pre-
anaesthetic induction setup: a randomized controlled trial in a simulation setting. 
2016; 739–46. 
31.  
Duclos A, Peix JL, Piriou V, Occelli P, Denis A, Bourdy S, et al. Cluster randomized 
trial to evaluate the impact of team training on surgical outcomes. 2016; 
32.  
Doumouras AG, Hamidi M, Lung K, Tarola CL, Tsao MW, Scott JW, et al. Non-
technical skills of surgeons and anaesthetists in simulated operating theater crises. 
33.  
Arriaga AF, Bader AM, Wong JM, Lipsitz SR, Berry WR, Ziewacz JE, et al. Simulation-
based trial of surgical-crisis checklists. N Engl J Med. 2013; 368 (3): 246–53. 
3. 4.  Khan A, Spector ND, Baird JD, Ashland M, Starmer AJ, Rosenbluth G, et al. Patient 
safety after implementation of a coproduced family centered communication 
program: multicenter before and after intervention study. 
35.  
Higham H, Greig PR, Rutherford J, Vincent L, Young D, Vincent C. Observer-based 
tools for non-technical skills assessment in simulated and real clinical environments 
in healthcare: A systematic review. BMJ Qual Saf. 2019; 1–15. 
36.  
Valentin B, Grottke O, Skorning M, Bergrath S, Fischermann H, Rörtgen D, et al. 
Cortisol and alpha-amylase as stress response indicators during pre-hospital 
emergency medicine training with repetitive high-fidelity simulation and scenarios 
with standardized patients. 2015; 1–8. 
37.  
Gu Y, Witter T, Livingston P, Rao P, Varshney T, Kuca T, et al. The effect of simulator 
fidelity on acquiring non-technical skills: a randomized non-inferiority trial. Can J 
Anesth. 2017; 64 (12): 1182–93. 
38.  
Maestre M, Rudolph W. ´as and styles of debriefing: the method with good 
judgment as formative theory in health assessment tool Theories and Styles of 
Debriefing: the Good Judgment Method as a Tool for Formative Assessment in 
Healthcare. 2015; 68 (4): 282–5. 
39.  
Zausig YA, Grube C, Boeker-Blum T, Busch CJ, Bayer Y, Sinner B, et al. Inefficacy of 
simulator-based training on anaesthesiologists' non-technical skills. Anesthesiol 
Scand Act. 2009; 53 (5): 611–9. 

40.  
Morgan PJ, Kurrek MM, Bertram S, Leblanc V, Przybyszewski T. Nontechnical Skills 
Assessment After Simulation-Based Continuing Medical Education. 2011; 6 (5): 255–
9. 
41.  
Hepner DL, Rubio J, Vasco-ramírez M, Rincón-valenzuela DA, Ruiz-villa JO, Amaya-
restrepo JC, et al. Colombian Journal of Anesthesiology Checklists of the Colombian 
Society of Anesthesiology and Reanimation (S. C. A. R. E.) For the management of 
critical events in operating rooms: translation and updating based on evidence. Rev 
Colomb Anestesiol [Internet]. 2017; (xx): 1–18. Available from: 
http://dx.doi.org/10.1016/j.rca.2017.04.003 
42.  
Zamudio Mario, González Daniela, López Laura CF. Validation in Spanish of the 
Ottawa scale for non-technical skills in health personnel in crisis situations. 
Medelllin; 2020. 
43.  
Introduction A. Advanced Statistics: Missing Data in Clinical Research — Part 1: An 
Introduction and Conceptual Framework. 2007; (Mi): 662–8. 
44.  
Emanuel EJ, Wendler D, Grady C. What Makes Clinical Research Ethical? 2000; 283 
(20): 2701–11. 
Four. Five.  
Regional O, Las P. International ethical guidelines for research related to 
health with human beings. 2014. 
46.  
Salud MDE, Salud ELMDE. MINISTRY OF HEALTH RESOLUTION NUMBER 8430 OF 
1993. 1993; 1993 (October 4): 1–19. 
47.  
The MDE, Social P. MINISTRY OF SOCIAL PROTECTION RESOLUTION NUMBER 2378 
OF 2008. 2008; 2008 (June 27): 1–93.