Hypoxemia During SurgeryNCT06016998
Prediction Model of Hypoxemia in Gastrointestinal Endoscopy Sedation
An observational study of Hypoxemia During Surgery, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxemia During Surgery
- How many people
- 1,023 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing painless gastroscopy in Sichuan Provincial People's Hospital
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction Model of Hypoxemia in Gastrointestinal Endoscopy Based on Facial Photography and Clinical Indicators
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.
Read the 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.
- Conditions
- Hypoxemia During Surgery
- Keywords
- Hypoxemia, Sedation, Prediction
- Medical subject headings
- Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of facial features
Measuring 50 sets of facial features through 5 facial photos
Measured: 1 day During the process of anesthesia assessment
Secondary outcomes (4)
BMI
Weight and height will be combined to report BMI in kg/m^2
Measured: 1 day During the process of anesthesia assessment
Neck circumference
Measure the neck circumference at the level of cricoid cartilage
Measured: 1 day During the process of anesthesia assessment
waist circumference
Measure waist circumference at navel level
Measured: 1 day During the process of anesthesia assessment
Modified Mallampati Score
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.
Measured: 1 day During the process of anesthesia assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Sep 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemia During SurgeryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mengchang Yang, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016998
- Sponsor's protocol ID
- FACIAL-123
- Status last verified
- Jan 2024
- First submitted
- 21 May 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model of Hypoxemia in Gastrointestinal Endoscopy Based on Facial Photography and Clinical Indicators
- ClinicalTrials.gov ID
- NCT06016998
- Acronym / sponsor ID
- FACIAL-123
- Conditions
- Hypoxemia During Surgery
- Keywords
- Hypoxemia, Sedation, Prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 30 Aug 2023 (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 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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing painless gastroscopy in Sichuan Provincial People's Hospital
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of facial features
Time frame: 1 day During the process of anesthesia assessment
Measuring 50 sets of facial features through 5 facial photos
4 secondary outcomes
BMI
Time frame: 1 day During the process of anesthesia assessment
Neck circumference
Time frame: 1 day During the process of anesthesia assessment
waist circumference
Time frame: 1 day During the process of anesthesia assessment
Modified Mallampati Score
Time frame: 1 day During the process of anesthesia assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypoxemia During Surgery, run by Sichuan Provincial People's Hospital 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of facial features (time frame: 1 day During the process of anesthesia assessment). 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 31 Jan 2024.