Difficult AirwayNCT04458220
Research on Early Warning and Solution System of Difficult Airway in Perioperative Period Based on Artificial Intelligence
An observational study of Difficult Airway, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Difficult Airway
- What is being tested?
- photo and voice obtained
- How many people
- 16,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2020to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Patients to be intubated under general anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
ming xia, Dr, 86-15021306970, jianghongjiuyuan@163.com
About this study
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.
- Conditions
- Difficult Airway
- Being tested
- photo and voice obtained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photo and voice obtainedOther
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.
| Study group | Role | What they receive |
|---|---|---|
| difficult airway | C-L≥Ⅲ grade Receives: Other: photo and voice obtained | |
| none difficult airway | C-L<Ⅲgrade Receives: Other: photo and voice obtained |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosed as a difficult airway
C-L≥Ⅲ grade
Measured: Just after intubation
Secondary outcomes (1)
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.
Measured: 2 minutes after administration of Rocuronium
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start30 Jul 2020
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult AirwayStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Jiang, Dr, Study chair, The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458220
- Sponsor's protocol ID
- SH9H-2020-T233-1
- Status last verified
- Jun 2023
- First submitted
- 18 Jun 2020
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Early Warning and Solution System of Difficult Airway in Perioperative Period Based on Artificial Intelligence
- ClinicalTrials.gov ID
- NCT04458220
- Acronym / sponsor ID
- SH9H-2020-T233-1
- Conditions
- Difficult Airway
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| difficult airway | – | Other: photo and voice obtainedC-L≥Ⅲ grade |
| none difficult airway | – | Other: photo and voice obtainedC-L<Ⅲgrade |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Patients to be intubated under general anesthesia.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photo and voice obtainedThe 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. | Other | difficult airway, none difficult airway |
Primary outcome
Diagnosed as a difficult airway
Time frame: Just after intubation
C-L≥Ⅲ grade
1 secondary outcome
Difficult mask ventilation
Time frame: 2 minutes after administration of Rocuronium
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Jiang, Dr study chair
The Ninth People's Hospital of Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Airway, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ren Zhou, Dr (86-15121007303, zhouren77@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosed as a difficult airway (time frame: Just after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.