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Study on the Decision Support System of Difficult Airway Evaluation

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06183060
Enrollment
1000
Registered
2023-12-27
Start date
2022-03-21
Completion date
2026-03-31
Last updated
2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Airway

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.

Interventions

PROCEDUREendotracheal intubation

all patients will receive laryngoscopy and endotracheal intubation

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Cormack-Lehane (CL) classificationDuring inductiondescribe laryngeal view during direct laryngoscopy

Secondary

MeasureTime frameDescription
X6(X-ray indicators)During review the X-ray imageatlanto-occipital gapantero-superior border of the first cervical vertebra
W (CT/MRI indicators)During review the CT/MRI imagethe maximal width of the tongue base
MRI1 (MRI indicators)During review the CT/MRI imagedistance between the base of the tongue and the posterior pharyngeal wall
MRI4 (MRI indicators)During review the CT/MRI imagedistance between the vocal cords and the posterior pharyngeal wall
MRI5 (MRI indicators)During review the CT/MRI imagelength of the epiglottis
MRI2 (MRI indicators)During review the CT/MRI imagedistance between the epiglottis and the posterior pharyngeal wall
MRI3 (MRI indicators)During review the CT/MRI imagedistance between the uvula and the posterior pharyngeal wall
V (CT/MRI indicators)During review the CT/MRI imagevolume of the tongue base
Rs (CT/MRI indicators)During review the CT/MRI imageRs= S/( Hp-h\* Dt-p); Rv =V/( Hp-h\* Dt-p\*W)
X1(X-ray indicators)During review the X-ray imagedistance between the temporomandibular joint and tip of the upper incisors
X2(X-ray indicators)During review the X-ray imageperpendicular distance from the hard palate to the tip of the upper incisors
X3(X-ray indicators)During review the X-ray imagelength of the mandibular body
X4(X-ray indicators)During review the X-ray imagevertical distance from the highest point of the hyoid bone to the mandibular body
X5(X-ray indicators)During review the X-ray imagedistance from the antero-inferior border of the fourth cervical vertebra to the antero-superior border of the first cervical vertebra
X7(X-ray indicators)During review the X-ray imagehorizontal distance from the highest point of the hyoid bone to the border of the nearest cervical vertebra
X8(X-ray indicators)During review the X-ray imagedistance between the spinous processes of the first cervical vertebra and the second cervical vertebra
A1 (X-ray indicators)During review the X-ray imagethe 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
Hp-h (CT/MRI indicators)During review the CT/MRI imagethe distance from back end of the hard palate to the top of hyoid
Ht (CT/MRI indicators)During review the CT/MRI imagethe 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 imagethe distance from the back end of tongue to posterior pharyngeal wall
Dt (CT/MRI indicators)During review the CT/MRI imagethe distance from the back end of tongue to Hp-h
S (CT/MRI indicators)During review the CT/MRI imagethe central sectional area of the tongue base behind Hp-h

Other

MeasureTime frameDescription
neck circumference,measurement one day before operation]physical indicator
modified Mallampati test,measurement one day before operation]physical indicator
thyromental distancemeasurement one day before operation]physical indicator
inter-incisor gapmeasurement one day before operation]physical indicator

Countries

China

Contacts

Primary ContactYongzheng Han, M.D.
hanyongzheng@bjmu.edu.cn+86 15201304460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026