An interventional study of Flexible-tip Bougie and Gum-elastic Bougie in Airway Obstruction, sponsored by Uniwersytet Radomski im. Kazimierza Pułaskiego. Completed at 1 site in Poland. Open to participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Uniwersytet Radomski im. Kazimierza Pułaskiego · Not applicable, Interventional, and Treatment
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.
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.
147 studies on the registry are indexed under Airway Obstruction; 25 are open to participants now.
This study's enrollment of 50 is close to the median of 53 across 92 interventional studies indexed under Airway Obstruction.
Browse Airway Obstruction studies →Uniwersytet Radomski im. Kazimierza Pułaskiego is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Paramedics using the flexible-tip bougie (the STIG)
Device: Flexible-tip Bougie
Paramedics using the gum-elastic bougie
Device: Gum-elastic Bougie
The device is used for intubation and then the manikin is ventilated
The device is used for intubation and then the manikin is ventilated
Successful intubation time
The time required to intubate and successfully ventilate the manikin
Time frame: From the date of randomization until the date of documented completion, assessed up to four months
First attempt success rate of intubation
The efficacy of evaluated airway adjuncts
Time frame: From the date of randomization until the date of documented completion, assessed up to four months
The ease of use and user-friendliness
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.
Time frame: From the date of randomization until the date of documented completion, assessed up to four months
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2025 to primary completion in May 2025, 1 month.
Of 36 non-industry interventional studies with no phase under Airway Obstruction, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 37. This study's 1 month is below that.
Counting every sponsor, half of 44 studies reached it within 16 months; a quarter within 3 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Uniwersytet Radomski im. Kazimierza Pułaskiego