Prediction Model of Hypoxemia in Gastrointestinal Endoscopy Sedation

NCT06016998 | Completed DMC

• 1 other identifier: FACIAL-123
• Study Type: observational
• Target: 1,023
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia During Surgery

Keywords

Hypoxemia; Sedation; Prediction

Outcome Measures

Primary Outcomes (1)

• Measurement of facial features

  Measuring 50 sets of facial features through 5 facial photos

  1 day During the process of anesthesia assessment

Secondary Outcomes (4)

• BMI

  1 day During the process of anesthesia assessment

• Neck circumference

  1 day During the process of anesthesia assessment

• waist circumference

  1 day During the process of anesthesia assessment

• Modified Mallampati Score

  1 day During the process of anesthesia assessment

Other Outcomes (3)

• Thyromental Distance

  1 day During the process of anesthesia assessment

• Upper lip bite test

  1 day During the process of anesthesia assessment

• interincisor gap

  1 day During the process of anesthesia assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing painless gastroscopy in Sichuan Provincial People's Hospital

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: August 30, 2023
• Study Start: September 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CN (1)