NCT06183060

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

December 27, 2023

Status Verified

November 1, 2023

Enrollment Period

3.8 years

First QC Date

November 20, 2023

Last Update Submit

December 22, 2023

Conditions

Difficult Airway

Outcome Measures

Primary Outcomes (1)

  • Cormack-Lehane (CL) classification

    describe laryngeal view during direct laryngoscopy

    During induction

Secondary Outcomes (22)

  • X1(X-ray indicators)

    During review the X-ray image

  • X2(X-ray indicators)

    During review the X-ray image

  • X3(X-ray indicators)

    During review the X-ray image

  • X4(X-ray indicators)

    During review the X-ray image

  • X5(X-ray indicators)

    During review the X-ray image

  • +17 more secondary outcomes

Other Outcomes (4)

  • inter-incisor gap

    measurement one day before operation]

  • thyromental distance

    measurement one day before operation]

  • neck circumference,

    measurement one day before operation]

  • +1 more other outcomes

Study Arms (2)

difficult laryngoscopy group

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

Procedure: endotracheal intubation

easy laryngoscopy group

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

Procedure: endotracheal intubation

Interventions

endotracheal intubationPROCEDURE

all patients will receive laryngoscopy and endotracheal intubation

difficult laryngoscopy groupeasy laryngoscopy group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing elective cervical spine surgery for cervical spondylosis (spinal cord and nerve root type

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related 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.

    PMID: 28376741RESULT

  • 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.

    PMID: 29388207RESULT

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Yongzheng Han, M.D.

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Yongzheng Han, M.D.

CONTACT

+86 15201304460hanyongzheng@bjmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 27, 2023

Study Start

March 21, 2022

Primary Completion

December 31, 2025

Study Completion

March 31, 2026

Last Updated

December 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

if necessary, access the data by contacting the project leader

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
after the project finished and manuscript published
Access Criteria
contact the project leader and data can only be used for scientific research

Locations

CN(1)