Research on Early Warning and Solution System of Difficult Airway in Perioperative Period Based on Artificial Intelligence

NCT ID: NCT04458220

Last Updated: 2023-08-01

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

UNKNOWN

Total Enrollment

16000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-30

Study Completion Date

2025-05-30

Brief Summary

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The study is performed in Shanghai Ninth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine . According to inclusion and exclusion criteria ,the investigators are expected to enroll 16000 participants who performed endotracheal intubation under general anesthesia. All enrolled participants must sign a written informed consent.In the preset studio,The 3D face scanner and camera is used to obtain 3D or 2-dimensional portrait images of patients in different positions and from different angles.The Hi-Fi Recorder is used to obtain sound samples of patients in different word.Then,Statistical experts use quantitative software to quantify the data.The investigators will put all the data and images into a confidential database in order to build a large database of difficult airways.

Anesthesiologist will give every patient an endotracheal intubation as planned. After that the anesthesiologist will be asked to fill out the questionnaire immediately.This questionnaire allows obtaining a ground truth for the intubation difficulty.All data will be used for AI deep learning and intelligent analysis,Several of the most relevant landmarks will be selected to build an early warning model.The overall study did not involve any intervention in the process of anaesthesia and operation of the patients, only the three-dimensional facial images of the patients were obtained, without any trauma or injury.

Detailed Description

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Conditions

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Difficult Airway

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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difficult airway

C-L≥Ⅲ grade

photo and voice obtained

Intervention Type OTHER

The 3D face scanner and camera is used to obtain 3D or 2-dimensional portrait images of patients in different positions and from different angles.The Hi-Fi Recorder is used to obtain sound samples of patients in different word.

none difficult airway

C-L\<Ⅲgrade

photo and voice obtained

Intervention Type OTHER

The 3D face scanner and camera is used to obtain 3D or 2-dimensional portrait images of patients in different positions and from different angles.The Hi-Fi Recorder is used to obtain sound samples of patients in different word.

Interventions

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photo and voice obtained

The 3D face scanner and camera is used to obtain 3D or 2-dimensional portrait images of patients in different positions and from different angles.The Hi-Fi Recorder is used to obtain sound samples of patients in different word.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients to be intubated under general anesthesia.

Exclusion Criteria

* Patients with deaf-mutism or communication disorders.
* Patients with language deficiency or non-native language.
* Patients with mental or central nervous system disease.
* Patients with stupefaction or disturbance of consciousness.
* Patients with terrible injury.
* Patients cannot follow instructions to perform standard actions.
* Patients participated in other relevant clinical investigation in the past 3 months.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hong Jiang, Dr

Role: STUDY_CHAIR

The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine

Locations

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The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ren Zhou, Dr

Role: CONTACT

86-15121007303

Ming Xia, Dr

Role: CONTACT

86-15021306970

Facility Contacts

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ming xia, Dr

Role: primary

86-15021306970

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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SH9H-2020-T233-1

Identifier Type: -

Identifier Source: org_study_id

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