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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| difficult airway | C-L≥Ⅲ grade |
| |
| none difficult airway | C-L<â…¢grade |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| photo and voice obtained | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosed as a difficult airway | C-L≥Ⅲ grade | Just after intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Difficult mask ventilation | The difficult mask ventilation was defined as follows: (1) the inability of an unassisted anesthesiologist to maintain oxygen saturation, as measured by SpO2<92% with 100% oxygen and positive-pressure mask ventilation; (2) significant gas flow leakage around the face mask; (3) the need to increase the gas flow to more than 15 L/min and use the oxygen flush valve more than twice (4) absence of visible chest movement; (5) the necessity to switch to a two-handed mask ventilation technique; (6) the need for operator substitution or addition. |
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Inclusion Criteria:
Exclusion Criteria:
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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 ,We are expected to enroll 16000 participants who performed endotracheal intubation under general anesthesia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ren Zhou, Dr | Contact | 86-15121007303 | zhouren77@126.com | |
| Ming Xia, Dr | Contact | 86-15021306970 | jianghongjiuyuan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Jiang, Dr | The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2020 | Jun 23, 2020 |
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| 2 minutes after administration of Rocuronium |
| ICF_000.pdf |