Prediction Model of Hypoxemia in Gastrointestinal Endoscopy Sedation

Sponsor
Sichuan Provincial People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06016998
Collaborator
(none)
900
3.9

Study Details

Study Description

Brief Summary

The incidence of hypoxemia during gastrointestinal endoscopy sedation is high, but there is still a lack of perfect prediction model of hypoxemia, which often leads to unpredictable respiratory complications. In order to ensure the safety of gastrointestinal endoscopy sedation and make emergency plans in advance, a better diagnostic model is urgently needed to help assess the risk of hypoxemia in patients undergoing the process and make early intervention measures. Facial photography is a simple and feasible measure that can show the facial soft tissue and structure of bone. The purpose of this study is to explore whether facial photography combined with other clinical indicators can build a prediction model of hypoxemia during gastrointestinal endoscopy sedation.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    900 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prediction Model of Hypoxemia in Gastrointestinal Endoscopy Based on Facial Photography and Clinical Indicators
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Dec 30, 2023
    Anticipated Study Completion Date :
    Dec 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of facial features [1 day During the process of anesthesia assessment]

      Measuring 50 sets of facial features through 5 facial photos

    Secondary Outcome Measures

    1. BMI [1 day During the process of anesthesia assessment]

      Weight and height will be combined to report BMI in kg/m^2

    2. Neck circumference [1 day During the process of anesthesia assessment]

      Measure the neck circumference at the level of cricoid cartilage

    3. waist circumference [1 day During the process of anesthesia assessment]

      Measure waist circumference at navel level

    4. Modified Mallampati Score [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.

    Other Outcome Measures

    1. Thyromental Distance [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.

    2. Upper lip bite test [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.

    3. interincisor gap [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Age ≥ 18 years old

    2. Patients undergoing painless gastroscopy

    3. The American Society of Anesthesiologists (ASA) grades I to III;

    4. The basic oxygenation SPO2 of the patient's breathing indoor air is ≥ 96%

    Exclusion Criteria:
    1. Have a history of symptomatic craniofacial abnormalities (such as Down syndrome)

    2. Previous history of craniofacial surgery

    3. There is too much facial hair, which clearly blurs the facial markings.

    4. Severe cardiopulmonary diseases such as myocardial infarction and bronchial asthma

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sichuan Provincial People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mengchang Yang, Deputy Chief Physician, Sichuan Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT06016998
    Other Study ID Numbers:
    • FACIAL-123
    First Posted:
    Aug 30, 2023
    Last Update Posted:
    Aug 30, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mengchang Yang, Deputy Chief Physician, Sichuan Provincial People's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 30, 2023