Supraglottic Airways for Entrapped Trauma Patients

Supraglottic Airway Devices for Airway Management of Entrapped Trauma Patients - an Evaluation of Four Devices in a Simulated Condition With Simultaneous Cervical Spine Immobilisation - a Randomised, Controlled Trial

The aim of this clinical trial is to evaluate four supraglottic airway devices for ventilation in a simulated condition of an entrapped trauma patient with simultaneous cervical spine immobilisation. All the studied devices are evaluated by fully-qualified and experienced paramedics (both male and female). The main questions it aims to answer are:

1. Which device requires the shortest time required to achieve a successful ventilation?
2. What is the first attempt success rate of the studied devices?
3. Which device is the easiest to use and the most user-friendly? Study participants will evaluate four different supraglottic devices in a restricted access to the entrapped trauma patient's airway. The maximum number of insertion attempts is limited to three per device.

Study Overview

• Status: Completed
• Conditions: Airway Obstruction
• Intervention / Treatment: Device: LMA Supreme; Device: SLIPA; Device: I-gel; Device: AuraGain

Detailed Description

A 10-minute lecture will be delivered before the start of the study. It will explain how to use the studied devices. Following the lecture all participants will be able to familiarise themselves with the equipment and practice for 30 minutes. A skill station will be set up containing an intubation manikin AT Kelly Torso (Laerdal Medical AS, Stavanger, Norway). A reduced movement of the cervical spine will be achieved by application of a Patriot® cervical collar (Össur hf., Reykjavik, Iceland). After completion of the initial practice the intubation manikin with the cervical collar on will be placed on and secured to the driver's seat of a medium-sized passenger car (FIAT S.p.A., Turin, Italy). The car will then be positioned on its left side and secured in place by firemen from a local fire brigade. The access to the manikin will only be allowed from the front i.e. through the opening created after removal of the windscreen. A single digit number will be allocated to each of the four studied devices i.e. 1 for the SLIPA device, 2 for the I-gel, 3 for the LMA Supreme and 4 for the LTS. Each study participant will be asked to randomly give a number (either 1, 2, 3 or 4) and will then be given the corresponding airway device to use. The maximum number of insertion attempts will be limited to three per device. The time required to insert the device and achieve a successful ventilation (Tiv) will be recorded. It will be measured using a stopwatch of a mobile phone (Apple Inc., Cupertino, California, USA). Efficacy of insertion/ventilation and the ease of use by the operator will also be assessed. The latter will be measured using an 11-point numerical rating scale (NRS) where 0 corresponds to a very difficult to use device and 10 indicates an easy to use and user-friendly device. A manual resuscitator (Ambu A/S, Ballerup, Denmark) will be used for ventilation and will be readily available to the paramedics. The study participants will perform all insertions with each of the four supraglottic airway devices. A failed insertion and ventilation is defined as an attempt during which the manikin cannot be ventilated or an attempt that lasted longer than 120 seconds. Only those who failed to ventilate will be allowed another attempt. All the obtained data will be analysed using Microsoft Office Excel 2021 spreadsheet (Microsoft Corporation, Redmond, WA, USA). The Kolmogorov-Smirnov test is utilised to determine whether the analysed variables matched the characteristics of a normal distribution. A paired Student t-test and the Wilcoxon signed-rank test will be used for data analysis. Based on our previous unpublished pilot study and assuming that the overall success rate of intubation in patients with a difficult airway would be 90% (α =0.05, 2-sided, β =0.1), 46 participants will be required. The final adjusted sample size, allowing a drop-out rate of about 10%, is 50 and this is the final number of participants enrolled into the study. A p-value of less than 0.05 (p<0.05) is considered statistically significant.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Radom, Mazowieckie, Poland, 26-600
      • University of Radom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• fully-qualified paramedics
• at least four years of practice after finishing paramedic training
• active (working) paramedics

Exclusion Criteria:

• paramedics in training
• retired paramedics
• lack of written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LMA Supreme Group; Paramedics using the LMA Supreme airway device	Device: LMA Supreme; The device is inserted and the manikin ventilated
Experimental: Other Supraglottic Airway Group; Paramedics using other supraglottic devices	Device: SLIPA; The device is inserted and the manikin ventilated; Other Names: I-gel; AuraGain; Device: I-gel; The device is inserted and the manikin ventilated; Device: AuraGain; The device is inserted and the manikin ventilated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful ventilation time	The time required to insert the device and achieve a successful ventilation	During procedure: 120 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt success rate of ventilation	The efficacy of an evaluated supraglottic airway device	During procedure: 120 seconds
The ease of use and user-friendliness	Device evaluation using the numerical rating scale (NRS). It is an 11-point scale where 0 corresponded to a very difficult to use device and 10 indicated an easy to use and user-friendly device.	During procedure: 120 seconds

Collaborators and Investigators

• Sponsor: Uniwersytet Radomski im. Kazimierza Pułaskiego
• Investigators: Principal Investigator: Dawid J Aleksandrowicz, PhD, University of Radom

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Airway Management; Paramedics; Entrapped Trauma Patients
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: 3/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No