Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05946694
Other study ID # RNN/363/13/KB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date February 1, 2023

Study information

Verified date July 2023
Source Medical University of Lodz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the study, three videolaryngoscopes: UESCOPE VL 400 (Zhejiang UE Medical Corp. Zhejiang, China), I-View™ VL (Intersurgical Ltd, Wokingham, Berkshire, UK), Airtraq sp® (Prodol Meditec S.A, Vizcaya, Spain) were compared with the most widely used, classic Macintosh laryngoscope (HEINE Optotechnik GmbH & Co. KG, Gilch-ing, Germany) under simulated out-of-hospital conditions by people without clinical experience on a manikin model (Laerdal Airway Management Trainer Stavanger Norway manikin of universal difficulty), while using an endotracheal tube without and with a stylet. Simulated out-of-hospital conditions were created by placing the manikin at floor level. A random selection of 30 students of the third year of Emergency Medicine, full-time first-degree program at the Medical University of Lodz, Poland, were enrolled in the study. The following were assessed: intubation efficiency, time to ventilation (primary endpoints); intubation effort, intubator comfort, tooth damage and visibility of the glottis according to the Cormack-Lehane scale (secondary endpoints).


Description:

Pre-study preparation All participants attended a 30-minute lecture on laryngoscope construction, principles of usage, anatomical structure of the airways, and intubation techniques. Following the lecture, the instructor demonstrated proper intubation using each of the four laryngoscopes that were being tested. Next, the students participated in a supervised workshop where they had the opportunity to intubate a mannequin placed on an operating table at an optimal height using each of the tested laryngoscopes with and without a stylet. One month later, 30 students participated in the actual study. Simulation model To create simulated out-of-hospital conditions, a certified airway training manikin (Laerdal Airway Management Trainer Stavanger Norway of universal difficulty) was placed in a neutral position at floor level. The trial tested three unchanneled videolaryngoscopes: UESCOPE VL 400 (Zhejiang UE Medical Corp. Zhejiang, China), I-View™ VL (Intersurgical Ltd, Wokingham, Berkshire, UK), Airtraq sp ® (Prodol Meditec S.A, Vizcaya, Spain), and a Macintosh laryngoscope (HEINE Optotechnik GmbH & Co. KG, Gilch-ing, Germany) (see Fig. 1). Each participant performed eight intubations on the manikin using all four devices. The intubation order was randomized using a blocked randomization strategy generated by the Randomizer Program (randomizer.org). A sealed opaque envelope was used to determine the order in which the laryngoscopes were used, and whether the tube was with or without a stylet. After each intubation, there was a minimum 10-minute pause before the next one. The subject then proceeded to the next intubation with the randomly selected laryngoscope, with the tube and stylet as determined by the sealed envelope. All intubations were performed using a polyvinyl chloride cuffed endotracheal tube (Covidien LLC, Hampshire Street, Mansfield, USA; internal diameter 7.0 mm) and an endotracheal stylet (Sumi® from sp. z o.o., 35 Drobiarska Street, 05-070 Sulejówek, Poland), when used. The endotracheal tubes and stylets were coated with a standard lubricant for simulators. All data were pseudonymized for each simulation. The time was measured by the same investigator (P.R.) using a stopwatch for all TI attempts. The timing measurement started when the participant picked up the laryngoscope and ended when initial ventilation was achieved using a resuscitation bag after the placement and sealing of the endotracheal tube. Successful TI was confirmed by observing the breathing movements of the manikin lungs. An unsuccessful attempt was defined by the absence of respiratory movements of the dummy or an intubation time of more than 60 seconds. This criterion was adopted because the study aimed to assess the suitability of the devices for individuals without clinical experience in intubation. Participants without sufficient skills or a good view of the glottis could prolong intubations without knowing how to solve the problem. In a real clinical scenario, such prolongation of intubation attempts beyond 60 seconds could result in irreversible brain damage in the victim, especially considering the necessary time for the emergency medical team to arrive. Participants rated the level of effort required to perform TI using the modified Borg scale (0 - no effort, 10 - maximum effort) and graded their comfort during the procedure as "full comfort, satisfactory comfort, moderate comfort, unsatisfactory comfort, and no comfort."


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - attaneding students Exclusion Criteria: - lack of conscent to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
intubation in manikin
Evaluation of 3 videolaryngoscopes under simulated out-of-hospital conditions by people without clinical experience on a manikin model

Locations

Country Name City State
Poland Medical University of Lodz, Poland Lódz

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary time to ventilation time from grabbing the laryngoscope to confirmed intubation measured in sec during the procedure
Primary intubation efficacy endotracheal intubation confirmed by ventilation of manikin's lungs, measured yes/no during the procedure
Secondary intubation effort how many intubations are required to success, measured in number of attempts during the procedure
Secondary intubator comfort, operator's experience measured with Borg scale during the procedure
Secondary tooth damage tooth damage recorded by manikin sensors, measured yes/no during the procedure
Secondary visibility of the glottis according to the Cormack-Lehane scale visibility of glottis in Cormack-Lehane score assessed by operators, measured using Cormack-Lehane scale during the procedure
See also
  Status Clinical Trial Phase
Completed NCT05116332 - Comparing the Variation in Laparoscopic Skills Acquisition in Obstetrics & Gynaecology and General Surgical Trainees
Completed NCT04147741 - Effects of a Pre-Workout on Performance, Perceptual Responses, Energy Feelings and Muscular Properties, After a Training Microcycle in Adults. N/A
Completed NCT05544838 - Simulated Comparison of Standard Versus Rotational Laryngeal Mask Airway Insertion in Novice Anaesthesiologists. N/A
Completed NCT05545163 - Comparison of Simulated Standard Versus Modified Jaw Thrust I-gel Insertion Technique in Novice Anesthesiologists N/A
Completed NCT05151757 - Developing and Testing a Low Cost Opportunistic Glaucoma Screening Model by Non-physician Graders in Vietnam N/A
Recruiting NCT03973463 - Effects of Diet Control and Resistance Exercise Training on Obesity Adults With Knee Osteoarthritis N/A
Active, not recruiting NCT06458283 - Effıcıency Of Hybrıd Based Sımulatıon Method In Breastfeedıng Educatıon N/A
Recruiting NCT04863677 - The Effect of HIIT, MICT in Patients With Myocardial Infarction N/A
Completed NCT06185439 - Prenatal Pilates Assisted Childbirth Preparation Training and Incontinence N/A
Not yet recruiting NCT05769088 - Effects of a Multi-Ingredient Pre-Workout Supplement on Body Composition, Performance, Muscular Properties, and Wellbeing in Adults. N/A
Completed NCT05923320 - The Effect of Education Given to Postpartum Women on Their Attitudes Towards Childhood Vaccinations and Breastfeeding N/A
Not yet recruiting NCT06283537 - Online Episiotomy Simulation Training for Midwifery Students N/A
Completed NCT04134741 - Assessment of Effectiveness of Neuromuscular Training in Treatment of Lumbar Spine in Football Players N/A
Completed NCT03477747 - The Application of Microcurrent in Athletes N/A
Completed NCT05769101 - Effects of a Recovery Supplement on Body Composition, Performance, Muscular Properties, and Wellbeing N/A
Completed NCT05991505 - Effect of Distance Physical Exercise on Mobility and Sleep Quality of Hypertensive Elderly Women N/A
Completed NCT05625672 - EFFICIENCY OF HEMOVIGILANCE MODULE TRAININGS GIVEN TO NURSES N/A