Study on the Decision Support System of Difficult Airway Evaluation

December 22, 2023 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
difficult laryngoscopy group
Cormack-Lehane (C-L) scale: class III-IV
Procedure: endotracheal intubation
all patients will receive laryngoscopy and endotracheal intubation
easy laryngoscopy group
Cormack-Lehane (C-L) scale: class I-II
Procedure: endotracheal intubation
all patients will receive laryngoscopy and endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cormack-Lehane (CL) classification
Time Frame: During induction
describe laryngeal view during direct laryngoscopy
During induction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
X1(X-ray indicators)
Time Frame: During review the X-ray image
distance between the temporomandibular joint and tip of the upper incisors
During review the X-ray image
X2(X-ray indicators)
Time Frame: During review the X-ray image
perpendicular distance from the hard palate to the tip of the upper incisors
During review the X-ray image
X3(X-ray indicators)
Time Frame: During review the X-ray image
length of the mandibular body
During review the X-ray image
X4(X-ray indicators)
Time Frame: During review the X-ray image
vertical distance from the highest point of the hyoid bone to the mandibular body
During review the X-ray image
X5(X-ray indicators)
Time Frame: 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
During review the X-ray image
X6(X-ray indicators)
Time Frame: During review the X-ray image
atlanto-occipital gapantero-superior border of the first cervical vertebra
During review the X-ray image
X7(X-ray indicators)
Time Frame: During review the X-ray image
horizontal distance from the highest point of the hyoid bone to the border of the nearest cervical vertebra
During review the X-ray image
X8(X-ray indicators)
Time Frame: During review the X-ray image
distance between the spinous processes of the first cervical vertebra and the second cervical vertebra
During review the X-ray image
A1 (X-ray indicators)
Time Frame: 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
During review the X-ray image
Hp-h (CT/MRI indicators)
Time Frame: During review the CT/MRI image
the distance from back end of the hard palate to the top of hyoid
During review the CT/MRI image
Ht (CT/MRI indicators)
Time Frame: During review the CT/MRI image
the height of the tongue base, along Hp-h from the tongue to the top of hyoid
During review the CT/MRI image
Dt-p (CT/MRI indicators)
Time Frame: During review the CT/MRI image
the distance from the back end of tongue to posterior pharyngeal wall
During review the CT/MRI image
Dt (CT/MRI indicators)
Time Frame: During review the CT/MRI image
the distance from the back end of tongue to Hp-h
During review the CT/MRI image
S (CT/MRI indicators)
Time Frame: During review the CT/MRI image
the central sectional area of the tongue base behind Hp-h
During review the CT/MRI image
W (CT/MRI indicators)
Time Frame: During review the CT/MRI image
the maximal width of the tongue base
During review the CT/MRI image
V (CT/MRI indicators)
Time Frame: During review the CT/MRI image
volume of the tongue base
During review the CT/MRI image
Rs (CT/MRI indicators)
Time Frame: During review the CT/MRI image
Rs= S/( Hp-h* Dt-p); Rv =V/( Hp-h* Dt-p*W)
During review the CT/MRI image
MRI1 (MRI indicators)
Time Frame: During review the CT/MRI image
distance between the base of the tongue and the posterior pharyngeal wall
During review the CT/MRI image
MRI2 (MRI indicators)
Time Frame: During review the CT/MRI image
distance between the epiglottis and the posterior pharyngeal wall
During review the CT/MRI image
MRI3 (MRI indicators)
Time Frame: During review the CT/MRI image
distance between the uvula and the posterior pharyngeal wall
During review the CT/MRI image
MRI4 (MRI indicators)
Time Frame: During review the CT/MRI image
distance between the vocal cords and the posterior pharyngeal wall
During review the CT/MRI image
MRI5 (MRI indicators)
Time Frame: During review the CT/MRI image
length of the epiglottis
During review the CT/MRI image

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
inter-incisor gap
Time Frame: measurement one day before operation]
physical indicator
measurement one day before operation]
thyromental distance
Time Frame: measurement one day before operation]
physical indicator
measurement one day before operation]
neck circumference,
Time Frame: measurement one day before operation]
physical indicator
measurement one day before operation]
modified Mallampati test,
Time Frame: measurement one day before operation]
physical indicator
measurement one day before operation]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yongzheng Han, M.D., Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00006761-M2022105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

if necessary, access the data by contacting the project leader

IPD Sharing Time Frame

after the project finished and manuscript published

IPD Sharing Access Criteria

contact the project leader and data can only be used for scientific research

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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