Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511427
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Difficult Airways Scores Validation Difficult Laryngoscopy and Mask Ventilation Prospective and Evaluative Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation of Clinical and Ultrasonographic Scores for Prediction of Difficult Laryngoscopy and Mask Ventilation Prospective and Evaluative Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation NC MMS retrognathia protrusion of the upper incisors TMD mouth opening dentition macroglossia presence of a beard UBLT spine mobility and palm print test for diabetes
Ultrasound airway assessment was performed Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation NC MMS retrognathia protrusion of the upper incisors TMD mouth opening dentition macroglossia presence of a beard UBLT spine mobility and palm print test for diabetes
Ultrasound airway assessment was performed Three parameters were measured to calculate the scores Tongue thickness TT in coronal plane Distance from the skin to hyoid bone SHB Distance from the skin to the thyrohyoid membrane STM Two scores were developed from a study conducted in 2019 The first score to predict a difficult laryngoscopy uses two parameters the modified MALLAMPATI class MMS and the STM A score strictly greater than 2 is predictive of a difficult laryngoscopy The second score to predict difficult ventilation uses four parameters BMI NC TT in coronal plane and SHB A score strictly greater than 20 is predictive of difficult ventilation A well-experienced anesthesiologist performed a direct laryngoscopy and graded it as Cormack-Lehanes grading
Difficulty in intubation andor mask ventilation was managed according to the 2017 SFAR guidelines
Ultrasound airway assessment was performed Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation NC MMS retrognathia protrusion of the upper incisors TMD mouth opening dentition macroglossia presence of a beard UBLT spine mobility and palm print test for diabetes
Ultrasound airway assessment was performed Three parameters were measured to calculate the scores Tongue thickness TT in coronal plane Distance from the skin to hyoid bone SHB Distance from the skin to the thyrohyoid membrane STM Two scores were developed from a study conducted in 2019 The first score to predict a difficult laryngoscopy uses two parameters the modified MALLAMPATI class MMS and the STM A score strictly greater than 2 is predictive of a difficult laryngoscopy The second score to predict difficult ventilation uses four parameters BMI NC TT in coronal plane and SHB A score strictly greater than 20 is predictive of difficult ventilation A well-experienced anesthesiologist performed a direct laryngoscopy and graded it as Cormack-Lehanes grading
Difficulty in intubation andor mask ventilation was managed according to the 2017 SFAR guidelines
Detailed Description:
The airway assessment was conducted in two phases evaluation of clinical parameters and ultrasound parameters Basics demographics such as age gender height weight BMI and comorbidities were noted along with the ASA classification and urgent or elective nature of the surgery Clinical screening tests were included to define a difficult laryngoscopy such as history of difficult or impossible intubation NC MMS retrognathia protrusion of the upper incisors TMD mouth opening dentition macroglossia presence of a beard UBLT spine mobility and palm print test for diabetes
Ultrasound airway assessment was performed using a sonosite portable sonography machine with a high-frequency linear probe 10MHz as well as a convex probe 35-5 MHz with the patient lying supine and keeping the head in a neutral position Three parameters were measured to calculate the scores Tongue thickness TT in coronal plane Distance from the skin to hyoid bone SHB Distance from the skin to the thyrohyoid membrane STM TT was measured with a low-frequency convex probe which was places submandibularly in a perpendicular plane the cross-sectional plane was the one passing through the two lingual arteries we considered the widest diameter SHB was measured by placing the linear high-frequency ultrasound probe transversely over the hyoid bone Similarly distance from skin to the thyrohyoid membrane STM was measured midway between hyoid and thyroid cartilage at the level of the epiglottis
The hyoid bone was identified as a curved echogenic structure with posterior acoustic shadow and epiglottis was identified as a curvilinear hypoechoic structure with a bright posterior air mucosal interface and hyperechoic pre-epiglottic space Two scores were developed from a study conducted in 2019 The first score to predict a difficult laryngoscopy uses two parameters the modified MALLAMPATI class MMS and the STM A score strictly greater than 2 is predictive of a difficult laryngoscopy The second score to predict difficult ventilation uses four parameters BMI NC TT in coronal plane and SHB A score strictly greater than 20 is predictive of difficult ventilation The patient was then shifted to the operating room electrocardioscope pulse oximetry gas analyzer capnography monitoring non-invasive blood pressure and neuromuscular blockade monitoring were connected Other monitoring methods could be used depending on the patient condition and surgical risk and their choice was left to the discretion of the anesthesiologist in charge of the patient After pre-oxygenation with 100 oxygen they were induced with intravenous injections of Sufentanil 03µgkg Propofol 3mgkg and cisatracurium 015mgkg or succinylcholine in case of a CRUSH induction A well-experienced anesthesiologist performed a direct laryngoscopy and graded it as Cormack-Lehanes grading
Difficulty in intubation andor mask ventilation was managed according to the 2017 SFAR guidelines
Ultrasound airway assessment was performed using a sonosite portable sonography machine with a high-frequency linear probe 10MHz as well as a convex probe 35-5 MHz with the patient lying supine and keeping the head in a neutral position Three parameters were measured to calculate the scores Tongue thickness TT in coronal plane Distance from the skin to hyoid bone SHB Distance from the skin to the thyrohyoid membrane STM TT was measured with a low-frequency convex probe which was places submandibularly in a perpendicular plane the cross-sectional plane was the one passing through the two lingual arteries we considered the widest diameter SHB was measured by placing the linear high-frequency ultrasound probe transversely over the hyoid bone Similarly distance from skin to the thyrohyoid membrane STM was measured midway between hyoid and thyroid cartilage at the level of the epiglottis
The hyoid bone was identified as a curved echogenic structure with posterior acoustic shadow and epiglottis was identified as a curvilinear hypoechoic structure with a bright posterior air mucosal interface and hyperechoic pre-epiglottic space Two scores were developed from a study conducted in 2019 The first score to predict a difficult laryngoscopy uses two parameters the modified MALLAMPATI class MMS and the STM A score strictly greater than 2 is predictive of a difficult laryngoscopy The second score to predict difficult ventilation uses four parameters BMI NC TT in coronal plane and SHB A score strictly greater than 20 is predictive of difficult ventilation The patient was then shifted to the operating room electrocardioscope pulse oximetry gas analyzer capnography monitoring non-invasive blood pressure and neuromuscular blockade monitoring were connected Other monitoring methods could be used depending on the patient condition and surgical risk and their choice was left to the discretion of the anesthesiologist in charge of the patient After pre-oxygenation with 100 oxygen they were induced with intravenous injections of Sufentanil 03µgkg Propofol 3mgkg and cisatracurium 015mgkg or succinylcholine in case of a CRUSH induction A well-experienced anesthesiologist performed a direct laryngoscopy and graded it as Cormack-Lehanes grading
Difficulty in intubation andor mask ventilation was managed according to the 2017 SFAR guidelines
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