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

NCT06609499 | Completed

• 1 other identifier: 04/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Obstruction

Keywords

tracheal intubation; trauma; entrapped patients,; introducer; flexible-tip bougie

Outcome Measures

Primary Outcomes (1)

• Successful intubation time

  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 Outcomes (2)

• First attempt success rate of intubation

  From the date of randomization until the date of documented completion, assessed up to four months

• The ease of use and user-friendliness

  From the date of randomization until the date of documented completion, assessed up to four months

Study Arms (2)

Flexible-tip Bougie Group

EXPERIMENTAL

Paramedics using the flexible-tip bougie (the STIG)

Device: Flexible-tip Bougie

Gum-elastic bougie Group

ACTIVE COMPARATOR

Paramedics using the gum-elastic bougie

Device: Gum-elastic Bougie

Interventions

Flexible-tip Bougie DEVICE

The device is used for intubation and then the manikin is ventilated

Flexible-tip Bougie Group

Gum-elastic Bougie DEVICE

The device is used for intubation and then the manikin is ventilated

Gum-elastic bougie Group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uniwersytet Radomski im. Kazimierza Pułaskiego: lead

Study Sites (1)

University of Radom

Radom, Masovian Voivodeship, 26-600, Poland

Location

MeSH Terms

Conditions

Airway Obstruction; Wounds and Injuries

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Dawid J Aleksandrowicz, PhD

  University of Radom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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. 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: March 15, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 31, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)