- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06016998
Prediction Model of Hypoxemia in Gastrointestinal Endoscopy Sedation
Prediction Model of Hypoxemia in Gastrointestinal Endoscopy Based on Facial Photography and Clinical Indicators
Study Overview
Status
Conditions
Detailed Description
Gastrointestinal endoscopy is an effective method for diagnosing gastrointestinal diseases. There is a increasing number of patients undergo gastrointestinal examinations year by year. Drug sedation can improve patient comfort and increase the intraoperative detection rate of digestive disease. At present, the most commonly used medication for gastrointestinal endoscopy sedation is propofol, which has a fast onset and short duration of time, making it very suitable for sedation during outpatient short surgeries. However, propofol can cause intraoperative hypoxemia. The hypoxemia is mainly caused by the respiratory inhibition of propofol and upper airway obstruction after anesthesia. Hypoxemia caused by respiratory inhibition can be optimized by adjusting the dose regimen. Hypoxemia caused by upper airway collapse is more urgent and more difficult to deal with, and usually requires suspension of gastroscopy and uses mask to ventilation , even needs undergo tracheal intubation. If patients suffer from hypoxemia for a long time, it can lead to myocardial ischemia, arrhythmia, permanent nerve injury, and even death and other serious complications. Conventional airway assessment methods have poor prediction ability for airway abnormalities, and imaging refined measurement indicators have good prediction ability, but their implementation is difficult and difficult to promote. At present, there is still a lack of accurate and simple prediction model for hypoxemia. It is still difficult to make a complete early warning for intraoperative respiratory complications, and intraoperative hypoxemia still occurs frequently. Therefore, in order to ensure the safety of gastrointestinal endoscopy sedation and make emergency plans in advance, a more complete diagnostic model is urgently needed to help assess the risk of hypoxemia in patients undergoing painless gastrointestinal endoscopy surgery and make early interventions.
Based on the above, the investigators assume that facial photography can provide a comprehensive measurement of risk factors for craniofacial bone and soft tissue (obesity). A prediction model constructed by combining facial photography measurement indicators with other relevant indicators can easily and efficiently predict airway abnormalities. Therefore, this study mainly explores the prediction model of craniofacial phenotype based on facial photos and combined clinical indicators for hypoxemia after gastrointestinal anesthesia.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sichuan
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Chengdu, Sichuan, China
- Sichuan Provincial People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years old
- Patients undergoing painless gastroscopy
- The American Society of Anesthesiologists (ASA) grades I to III;
- The basic oxygenation SPO2 of the patient's breathing indoor air is ≥ 96%
Exclusion Criteria:
- Have a history of symptomatic craniofacial abnormalities (such as Down syndrome)
- Previous history of craniofacial surgery
- There is too much facial hair, which clearly blurs the facial markings.
- Severe cardiopulmonary diseases such as myocardial infarction and bronchial asthma
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of facial features
Time Frame: 1 day During the process of anesthesia assessment
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Measuring 50 sets of facial features through 5 facial photos
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1 day During the process of anesthesia assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI
Time Frame: 1 day During the process of anesthesia assessment
|
Weight and height will be combined to report BMI in kg/m^2
|
1 day During the process of anesthesia assessment
|
Neck circumference
Time Frame: 1 day During the process of anesthesia assessment
|
Measure the neck circumference at the level of cricoid cartilage
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1 day During the process of anesthesia assessment
|
waist circumference
Time Frame: 1 day During the process of anesthesia assessment
|
Measure waist circumference at navel level
|
1 day During the process of anesthesia assessment
|
Modified Mallampati Score
Time Frame: 1 day During the process of anesthesia assessment
|
The patient is asked to sit upright, with the head in the center, the mouth as wide as possible, the tongue as far out as possible, no pronunciation is required, the pharyngeal structure is observed, and the observation is repeated twice to avoid false positives or false negatives.It is divided into four levels according to the structure of the pharynx.Higher level indicates difficulty in airway management.
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1 day During the process of anesthesia assessment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thyromental Distance
Time Frame: 1 day During the process of anesthesia assessment
|
Measure the distance from thyroid cartilage to the chin.If the distance is less than six centimeters, it indicates difficulty in airway management.
|
1 day During the process of anesthesia assessment
|
Upper lip bite test
Time Frame: 1 day During the process of anesthesia assessment
|
The patient is in a sitting position, with the lower jaw extending forward as much as possible and using the lower incisor to bite the lip line of the upper lip as much as possible.
The level I lower incisor bites above the lip line of the upper lip; Level II lower incisors can bite below the red lip of the upper lip; Level III lower incisors cannot bite the upper lip.Higher level indicates difficulty in airway management.
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1 day During the process of anesthesia assessment
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interincisor gap
Time Frame: 1 day During the process of anesthesia assessment
|
Measure the distance between the upper and lower incisors .If the distance is less than three centimeters, it may indicate difficulty in airway management.
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1 day During the process of anesthesia assessment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FACIAL-123
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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