Evaluation of Airway Adjuncts for Intubation in Entrapped Patients With Difficult Airway Access

August 28, 2025 updated by: Uniwersytet Radomski im. Kazimierza Pułaskiego

Standard Gum Elastic Bougie Versus Flexible-tip Bougie: Evaluation of Airway Adjuncts for Intubation in Entrapped Patients With Difficult Airway Access - a Randomised, Controlled Trial

The aim of this clinical trial is to evaluate two airway adjuncts for intubation 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:

Which device requires the shortest time required to achieve a successful intubation and ventilation? What is the first attempt success rate of the studied devices? Which device is the easiest to use and the most user-friendly? Study participants will evaluate two different airway adjuncts for intubation 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

Intervention / Treatment

Detailed Description

A written informed consent will be obtained from all study participants. Only qualified paramedics will participate in the study. Their experience varies between four and eight years of practice after completion of paramedic training. All study participants had never used the flexible-tip bougie but had a routine intubation experience with the standard gum elastic bougie (more than 40 intubations previously performed).

A 10-minute lecture will be delivered before the start of the study. It will explain how to use the STIG. 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 wall be placed on and secured to the driver's seat of a FIAT Bravo 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 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 two studied devices i.e. 1 for the flexible-tip bougie and 2 for the standard gum elastic bougie (SUMI Sp. z o.o., Sp. K., Sulejówek, Poland). Each study participant will be asked to randomly give a number (either 1 or 2) and will then be given the corresponding tracheal tube introducer to use. The maximum number of intubation attempts is limited to three per device. The time required to intubate and successfully ventilate (Ti) the manikin will be recorded. It will be measured using a stopwatch of a mobile phone (Apple Inc., Cupertino, California, USA). Efficacy of intubation 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 introducer. Size 7.5 tracheal tube (SUMI Sp. z o.o., Sp. K., Sulejówek, Poland) will be utilised in the study. A manual resuscitator (Ambu A/S, Ballerup, Denmark) will be used for ventilation and will be readily available to the paramedics. The standard Macintosh-blade laryngoscope (New Waseem Trading Co., Sialkot, Pakistan) will be utilised for direct laryngoscopy. Size three blade will be used. The study participants will perform all intubations with each of the two tracheal tube introducers. A failed intubation will be defined as an attempt during which the trachea cannot be intubated or an attempt that lasts longer than 120 seconds. Only those who failed to intubate will be allowed another attempt. All the obtained data will be analysed using Microsoft Office Excel 2021 spreadsheet (Microsoft Corporation, Redmond, WA, USA) and GraphPad Prism (GraphPad Software, Boston, MA, USA). The Kolmogorov-Smirnov test will be utilised to determine whether the analysed variables matches 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 will be 90% (α =0.05, 2-sided, β =0.1), 46 participants are required. The final adjusted sample size, allowing a drop-out rate of about 10%, will be 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

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

Study Locations

  • Poland
    • Masovian Voivodeship
      • Radom, Masovian Voivodeship, Poland, 26-600
        • University of Radom

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

  • 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

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flexible-tip Bougie Group
Paramedics using the flexible-tip bougie (the STIG)
Device: Flexible-tip Bougie
The device is used for intubation and then the manikin is ventilated
Active Comparator: Gum-elastic bougie Group
Paramedics using the gum-elastic bougie
Device: Gum-elastic Bougie
The device is used for intubation and then the manikin is ventilated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful intubation time
Time Frame: From the date of randomization until the date of documented completion, assessed up to four months
The time required to intubate and successfully ventilate the manikin
From the date of randomization until the date of documented completion, assessed up to four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First attempt success rate of intubation
Time Frame: From the date of randomization until the date of documented completion, assessed up to four months
The efficacy of evaluated airway adjuncts
From the date of randomization until the date of documented completion, assessed up to four months
The ease of use and user-friendliness
Time Frame: From the date of randomization until the date of documented completion, assessed up to four months
Device evaluation using the numerical rating scale (NRS). It is an 11-point scale where 0 corresponds to a very difficult to use device and 10 indicates an easy to use and user-friendly device.
From the date of randomization until the date of documented completion, assessed up to four months

Collaborators and Investigators

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

Sponsor

Uniwersytet Radomski im. Kazimierza Pułaskiego

Investigators

  • Principal Investigator: Dawid J Aleksandrowicz, PhD, University of Radom

Study record dates

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

Study Major Dates

Study Start (Actual)

March 15, 2025

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/2024

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

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

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