Clinical trial NCT06183060: Study on the Decision Support System of Difficult Airway Evaluation
Official title: Department of Anesthesiology, Peking University Third Hospital, Associate Chief Physician; M.D.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Difficult Airway
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing elective cervical spine surgery for cervical spondylosis (spinal cord and nerve root type

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cormack-Lehane (CL) classification
timeFrame: During induction
Secondary outcomes:
measure: X1(X-ray indicators)
timeFrame: During review the X-ray image
measure: X2(X-ray indicators)
timeFrame: During review the X-ray image
measure: X3(X-ray indicators)
timeFrame: During review the X-ray image
measure: X4(X-ray indicators)
timeFrame: During review the X-ray image
measure: X5(X-ray indicators)
timeFrame: During review the X-ray image
measure: X6(X-ray indicators)
timeFrame: During review the X-ray image
measure: X7(X-ray indicators)
timeFrame: During review the X-ray image
measure: X8(X-ray indicators)
timeFrame: During review the X-ray image
measure: A1 (X-ray indicators)
timeFrame: During review the X-ray image
measure: Hp-h (CT/MRI indicators)
timeFrame: During review the CT/MRI image
measure: Ht (CT/MRI indicators)
timeFrame: During review the CT/MRI image
measure: Dt-p (CT/MRI indicators)
timeFrame: During review the CT/MRI image
measure: Dt (CT/MRI indicators)
timeFrame: During review the CT/MRI image
measure: S (CT/MRI indicators)
timeFrame: During review the CT/MRI image
measure: W (CT/MRI indicators)
timeFrame: During review the CT/MRI image
measure: V (CT/MRI indicators)
timeFrame: During review the CT/MRI image
measure: Rs (CT/MRI indicators)
timeFrame: During review the CT/MRI image
measure: MRI1 (MRI indicators)
timeFrame: During review the CT/MRI image
measure: MRI2 (MRI indicators)
timeFrame: During review the CT/MRI image
measure: MRI3 (MRI indicators)
timeFrame: During review the CT/MRI image
measure: MRI4 (MRI indicators)
timeFrame: During review the CT/MRI image
measure: MRI5 (MRI indicators)
timeFrame: During review the CT/MRI image
Other outcomes:
measure: inter-incisor gap
timeFrame: measurement one day before operation]
measure: thyromental distance
timeFrame: measurement one day before operation]
measure: neck circumference,
timeFrame: measurement one day before operation]
measure: modified Mallampati test,
timeFrame: measurement one day before operation]
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yongzheng Han, M.D.
role: STUDY_CHAIR
References:
citation: 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.
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.