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Study on the Decision Support System of Difficult Airway Evaluation

NCT ID: NCT06183060

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-21

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Difficult Airway

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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difficult laryngoscopy group

Cormack-Lehane (C-L) scale: class III-IV

endotracheal intubation

Intervention Type PROCEDURE

all patients will receive laryngoscopy and endotracheal intubation

easy laryngoscopy group

Cormack-Lehane (C-L) scale: class I-II

endotracheal intubation

Intervention Type PROCEDURE

all patients will receive laryngoscopy and endotracheal intubation

Interventions

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endotracheal intubation

all patients will receive laryngoscopy and endotracheal intubation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yongzheng Han, M.D.

Role: STUDY_CHAIR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongzheng Han, M.D.

Role: CONTACT

Phone: +86 15201304460

Email: [email protected]

Facility Contacts

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Yongzheng Han, M.D.

Role: primary

References

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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.

Reference Type RESULT
PMID: 28376741 (View on PubMed)

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.

Reference Type RESULT
PMID: 29388207 (View on PubMed)

Other Identifiers

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IRB00006761-M2022105

Identifier Type: -

Identifier Source: org_study_id