Study on the Decision Support System of Difficult Airway Evaluation

Recruiting

• Conditions: Difficult Airway
• Interventions: Procedure: endotracheal intubation

• Registration Number: NCT06183060
• Lead Sponsor: Peking University Third Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-03-21
• Status Verified: 2023-11
• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-12-22
• Last Update Submitted: 2023-12-22
• Study First Posted: 2023-12-27
• Last Update Posted: 2023-12-27
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• patients of ASA I-III
• scheduled for elective surgery for cervical spondylosis under general anesthesia with tracheal intubation

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Exclusion Criteria

• patients with cervical spine instability
• oropharyngeal mass
• airway disease
• preoperative imaging data were incomplete
• refuse to sign informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
easy laryngoscopy group	endotracheal intubation	Cormack-Lehane (C-L) scale: class I-II
difficult laryngoscopy group	endotracheal intubation	Cormack-Lehane (C-L) scale: class III-IV

Primary Outcome Measures

Name	Time	Method
Cormack-Lehane (CL) classification	During induction	describe laryngeal view during direct laryngoscopy

Secondary Outcome Measures

Name	Time	Method
MRI2 (MRI indicators)	During review the CT/MRI image	distance between the epiglottis and the posterior pharyngeal wall
X2(X-ray indicators)	During review the X-ray image	perpendicular distance from the hard palate to the tip of the upper incisors
X3(X-ray indicators)	During review the X-ray image	length of the mandibular body
Dt (CT/MRI indicators)	During review the CT/MRI image	the distance from the back end of tongue to Hp-h
X7(X-ray indicators)	During review the X-ray image	horizontal distance from the highest point of the hyoid bone to the border of the nearest cervical vertebra
W (CT/MRI indicators)	During review the CT/MRI image	the maximal width of the tongue base
V (CT/MRI indicators)	During review the CT/MRI image	volume of the tongue base
MRI1 (MRI indicators)	During review the CT/MRI image	distance between the base of the tongue and the posterior pharyngeal wall
MRI4 (MRI indicators)	During review the CT/MRI image	distance between the vocal cords and the posterior pharyngeal wall
MRI5 (MRI indicators)	During review the CT/MRI image	length of the epiglottis
X4(X-ray indicators)	During review the X-ray image	vertical distance from the highest point of the hyoid bone to the mandibular body
X5(X-ray indicators)	During review the X-ray image	distance from the antero-inferior border of the fourth cervical vertebra to the antero-superior border of the first cervical vertebra
X8(X-ray indicators)	During review the X-ray image	distance between the spinous processes of the first cervical vertebra and the second cervical vertebra
A1 (X-ray indicators)	During review the X-ray image	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
S (CT/MRI indicators)	During review the CT/MRI image	the central sectional area of the tongue base behind Hp-h
Rs (CT/MRI indicators)	During review the CT/MRI image	Rs= S/( Hp-h\* Dt-p); Rv =V/( Hp-h\* Dt-p\*W)
MRI3 (MRI indicators)	During review the CT/MRI image	distance between the uvula and the posterior pharyngeal wall
X1(X-ray indicators)	During review the X-ray image	distance between the temporomandibular joint and tip of the upper incisors
X6(X-ray indicators)	During review the X-ray image	atlanto-occipital gapantero-superior border of the first cervical vertebra
Hp-h (CT/MRI indicators)	During review the CT/MRI image	the distance from back end of the hard palate to the top of hyoid
Ht (CT/MRI indicators)	During review the CT/MRI image	the height of the tongue base, along Hp-h from the tongue to the top of hyoid
Dt-p (CT/MRI indicators)	During review the CT/MRI image	the distance from the back end of tongue to posterior pharyngeal wall

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China