Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609499
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Evaluation of Airway Adjuncts for Intubation in Entrapped Patients With Difficult Airway Access
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients airway The maximum number of insertion attempts is limited to three per device
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 patients airway The maximum number of insertion attempts is limited to three per device
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 drivers seat of a FIAT Bravo car FIAT SpA 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 ie through the opening created after removal of the windscreen A single digit number will be allocated to each of the two studied devices ie 1 for the flexible-tip bougie and 2 for the standard gum elastic bougie SUMI Sp z oo 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 75 tracheal tube SUMI Sp z oo Sp K Sulejówek Poland will be utilised in the study A manual resuscitator Ambu AS 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 005 2-sided β 01 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 005 p005 is considered statistically significant
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 drivers seat of a FIAT Bravo car FIAT SpA 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 ie through the opening created after removal of the windscreen A single digit number will be allocated to each of the two studied devices ie 1 for the flexible-tip bougie and 2 for the standard gum elastic bougie SUMI Sp z oo 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 75 tracheal tube SUMI Sp z oo Sp K Sulejówek Poland will be utilised in the study A manual resuscitator Ambu AS 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 005 2-sided β 01 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 005 p005 is considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None