Study on the Decision Support System of Difficult Airway Evaluation

Difficult Airway Clinical Trial

Official title:

Department of Anesthesiology, Peking University Third Hospital, Associate Chief Physician; M.D.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183060
• Other study ID #: IRB00006761-M2022105
• Status: Recruiting
• Start date: March 21, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: November 2023
• Source: Peking University Third Hospital
• Contact: Yongzheng Han, M.D.
• Phone: +86 15201304460
• Email: hanyongzheng[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Based on the evaluation of preoperative physical indicators and radiologic indicators of cervical surgery, this study puts forward effective indicators for predicting difficult airway before operation, and establishes a comprehensive decision support system of difficult airway evaluation, so as to provide a theoretical basis for the early warning of difficult airway before cervical spondylosis surgery.

Description:

In the past, the evaluation of difficult airway mainly depended on physical indicators, but the internal structure of airway could not be found by appearance inspection. Therefore, unexpected emergency airway often appeared in clinical work, which seriously affected medical safety. In this study, the specific mechanism of difficult laryngoscopy in patients undergoing cervical spondylosis surgery is clarified by the combination of the physical indicators and radiologic indicators. On this basis, we will establish the preoperative airway evaluation system for cervical spondylosis surgery, optimize the standardized process of preoperative airway evaluation, and accurately screen out high-risk patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients of ASA I-III

• scheduled for elective surgery for cervical spondylosis under general anesthesia with tracheal intubation

Exclusion Criteria:

• patients with cervical spine instability

• oropharyngeal mass

• airway disease

• preoperative imaging data were incomplete

• refuse to sign informed consent

Related Conditions & MeSH terms

• Difficult Airway

Intervention

Procedure:
• endotracheal intubation
all patients will receive laryngoscopy and endotracheal intubation

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Han YZ, Tian Y, Xu M, Ni C, Li M, Wang J, Guo XY. Neck circumference to inter-incisor gap ratio: a new predictor of difficult laryngoscopy in cervical spondylosis patients. BMC Anesthesiol. 2017 Apr 4;17(1):55. doi: 10.1186/s12871-017-0346-y. — View Citation

Han YZ, Tian Y, Zhang H, Zhao YQ, Xu M, Guo XY. Radiologic indicators for prediction of difficult laryngoscopy in patients with cervical spondylosis. Acta Anaesthesiol Scand. 2018 Apr;62(4):474-482. doi: 10.1111/aas.13078. Epub 2018 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	inter-incisor gap	physical indicator	measurement one day before operation]
Other	thyromental distance	physical indicator	measurement one day before operation]
Other	neck circumference,	physical indicator	measurement one day before operation]
Other	modified Mallampati test,	physical indicator	measurement one day before operation]
Primary	Cormack-Lehane (CL) classification	describe laryngeal view during direct laryngoscopy	During induction
Secondary	X1(X-ray indicators)	distance between the temporomandibular joint and tip of the upper incisors	During review the X-ray image
Secondary	X2(X-ray indicators)	perpendicular distance from the hard palate to the tip of the upper incisors	During review the X-ray image
Secondary	X3(X-ray indicators)	length of the mandibular body	During review the X-ray image
Secondary	X4(X-ray indicators)	vertical distance from the highest point of the hyoid bone to the mandibular body	During review the X-ray image
Secondary	X5(X-ray indicators)	distance from the antero-inferior border of the fourth cervical vertebra to the antero-superior border of the ?rst cervical vertebra	During review the X-ray image
Secondary	X6(X-ray indicators)	atlanto-occipital gapantero-superior border of the ?rst cervical vertebra	During review the X-ray image
Secondary	X7(X-ray indicators)	horizontal distance from the highest point of the hyoid bone to the border of the nearest cervical vertebra	During review the X-ray image
Secondary	X8(X-ray indicators)	distance between the spinous processes of the ?rst cervical vertebra and the second cervical vertebra	During review the X-ray image
Secondary	A1 (X-ray indicators)	the angle between a line passing through the bottom of second cervical vertebra and a line passing through the bottom of sixth cervical vertebra in the neutral/ extension position	During review the X-ray image
Secondary	Hp-h (CT/MRI indicators)	the distance from back end of the hard palate to the top of hyoid	During review the CT/MRI image
Secondary	Ht (CT/MRI indicators)	the height of the tongue base, along Hp-h from the tongue to the top of hyoid	During review the CT/MRI image
Secondary	Dt-p (CT/MRI indicators)	the distance from the back end of tongue to posterior pharyngeal wall	During review the CT/MRI image
Secondary	Dt (CT/MRI indicators)	the distance from the back end of tongue to Hp-h	During review the CT/MRI image
Secondary	S (CT/MRI indicators)	the central sectional area of the tongue base behind Hp-h	During review the CT/MRI image
Secondary	W (CT/MRI indicators)	the maximal width of the tongue base	During review the CT/MRI image
Secondary	V (CT/MRI indicators)	volume of the tongue base	During review the CT/MRI image
Secondary	Rs (CT/MRI indicators)	Rs= S/( Hp-h* Dt-p); Rv =V/( Hp-h* Dt-p*W)	During review the CT/MRI image
Secondary	MRI1 (MRI indicators)	distance between the base of the tongue and the posterior pharyngeal wall	During review the CT/MRI image
Secondary	MRI2 (MRI indicators)	distance between the epiglottis and the posterior pharyngeal wall	During review the CT/MRI image
Secondary	MRI3 (MRI indicators)	distance between the uvula and the posterior pharyngeal wall	During review the CT/MRI image
Secondary	MRI4 (MRI indicators)	distance between the vocal cords and the posterior pharyngeal wall	During review the CT/MRI image
Secondary	MRI5 (MRI indicators)	length of the epiglottis	During review the CT/MRI image