Study population and design
The study was approved by the The Lithuanian University of Health Sciences Bioethics Commission no. BEC-MF-442. All procedures performed in studies involving human participants were in accordance with the ethics standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethics standards. All the participants gave written informed consent.
This was a randomized experimental design with 78 medical students in their 5th year course in the Anesthesia module and 22 first-year residents of Emergency Medicine and Anesthesiology. The study was carried out at LUHS from May 1st through June 1st, 2019. Randomization was performed prior to the teaching using a random number generator. Initially 50 students/residents were allocated to each study group (a) conventional simulation-based learning group (control group) and (b) the hybrid learning group (experimental group). Subjects who had previous similar practical skill training or experience were excluded from the study, as well as participants who failed to complete the course.
The participants in both groups studied the principles of safe airway management and practical skills of endotracheal (orotracheal) intubation. The learning aim and goals were identical for both groups, and the content of theoretical knowledge and skill set were aligned. Sixteen participants in the conventional simulation group and 7 participants in the hybrid group were excluded from the analysis. In total, 77 participants remained in the study (Fig. 1).
The conventional simulation-based training group teaching process consisted of lectures and practical skills with hands-on training sessions. The total duration of the course was six hours. During the simulation-based training sessions, the correct procedure for endotracheal intubation was demonstrated by the teacher on a manikin, which was followed by participants performing the intubation on the manikin under the teacher’s supervision.
The hybrid group initially studied the necessary theoretical material, lectures, videos, and algorithms on a virtual learning environment (which is comparable to Moodle and other widely used distance learning platforms). The students continued with the practical training only after passing an online test containing 10 questions with a perfect score. After the individual theoretical preparation, the subjects organized themselves into the groups of three for peer-to-peer practical skills training sessions in the HybridLab (Fig. 2). The pre-planned estimated duration of the skills training was six hours for each group. However, the HybridLab subjects were encouraged to adapt the learning time based on their needs and practice at their own pace as they had 24/7 access to the training lab and did not need to coordinate the timing with the technician and/or instructor. When learning practical skills, the subjects were using the same manikin and equipment as in the conventional simulation-based training group. However, this group had the supplementary support of hand-held tablets containing proprietary educational software, electronic scenarios and checklists for clinical situation assessment and feedback (Fig. 3) as well as the learning algorithms (Fig. 4), which enabled simulation and training in the absence of a technician or instructor.
Training sessions were video recorded on the cameras that were installed in the lab. The records of both the training and evaluation scenarios were viewed and evaluated remotely by the teachers. Standardized checklists were used for the evaluation, which were the same as what the subjects were using in training class. The evaluation and feedback of the teacher was provided by email.
Subjects were then asked to evaluate the course. Out of 77 participants, 58 (22 in conventional and 36 in hybrid group) completed the post-course survey. Two questions were asked regarding confidence and satisfaction: 1. After learning, I think I will pass the test successfully. 2. I enjoyed studying in this module. Each question had a 5-point Likert-type scale to evaluate the degree of student's agreement to a given statement, as follows: score 5 for strongly agree, 4 for agree, 3 for undecided, 2 for disagree, and 1 for strongly disagree.
For the final evaluation of both groups, endotracheal intubation procedures were performed on real patients in the operation room (OR) under the direct supervision of the clinical teacher (anesthesiologist). The only patients who were selected for the intubation were grade I and II patients according to the American Society of Anesthesiologists (ASA) [9]. To ensure the patient’s safety, each procedure step was closely monitored and if necessary, immediately corrected by an anesthesiologist. In addition, each step of the procedure was evaluated using the standardized assessment form (checklist). The checklist consisted of 16 steps (Fig. 3) and comprised the following parts: preparation for intubation, laryngoscopy, insertion of endotracheal tube, and verification of the placement of the endotracheal tube. The task was evaluated by the anesthesiologist who was blinded to the group the subject was enrolled in.
The sequence of endotracheal intubation procedure actions was assessed and compared between the groups. Also, participants were divided into groups according to the scope of activities performed ( ~ > 76%, 75 − 51%, 50 − 26%, < 25%). Additionally, the satisfaction and confidence responses were compared between the groups.
Statistical analysis
With an assumption that the difference in learning outcomes will be 30% better in the HybridLab group as compared with the conventional trained group, and with a statistical power of 0.8 and a risk of 0.05 for type-1 error, 30 participants were required in each group. For possible dropouts, 50 participants in each group were enrolled in the study.
To determine whether the data were normally distributed, a Shapiro–Wilk normality test was applied. As most of the data were not normally distributed, data were presented in medians (interquartile ranges) and rates. Also, a non-parametric independent-samples t-test for was used. The χ² or Fisher’s exact test was used when comparing the proportions between the groups. P values < 0.05 were considered significant. SPSS software (SPSS, Chicago, Ill) was used for the calculations.