Observation of Clinical Effect of New Oropharyngeal Airway in Patients With OSHAS During Painless Gastroenteroscopy

Launched by JIANBO WU · Sep 10, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new device designed to help patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) breathe better during painless gastrointestinal endoscopy procedures, such as stomach and colon examinations. Patients with OSAHS often experience breathing difficulties during sleep, which can become worse when sedatives are used for procedures like these. The new oropharyngeal airway is intended to improve airflow and reduce the risk of low oxygen levels during the procedure.

To participate in this trial, individuals should be between 18 and 65 years old and have a confirmed diagnosis of OSAHS based on sleep monitoring. They should also be able to give informed consent, either themselves or through a family member. However, certain individuals will not be eligible, such as those with bleeding disorders, respiratory infections, or a history of severe mental health conditions. Participants will be monitored closely during the procedure to see if the new device helps maintain safe oxygen levels. Overall, this trial aims to determine if this innovative airway device can enhance safety for patients undergoing gastroenteroscopy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-65 years old
• • evidence of polysleep monitoring for diagnosis of OSAHS
• • written informed consent of patient or family member
• • painless stomach + colonoscopy
• • ASA grade I-II
• Exclusion criteria:
• • Patients with clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who could not perform oropharyngeal airway ventilation;
• • Upper respiratory tract infections such as mouth, nose or throat;
• • Fever (core body temperature ≥37.5℃);
• • a confirmed diagnosis of pregnancy or breastfeeding;
• • Allergic to sedatives such as propofol or equipment such as tape;
• • Emergency surgery;
• • Multiple trauma;
• • SpO2 \< 95% before operation;
• • A history of drug and/or alcohol abuse within 2 years prior to the start of the screening period;(Drinking more than three times standard alcoholic beverages per day, equivalent to about 10g of alcohol or equivalent to 50g of Chinese liquor);
• • Patients with previous psychiatric and neurological diseases, such as depression, severe central nervous depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis;
• • Currently participating in other clinical trials;
• • Patients who are deemed unfit by the investigator to participate in the trial;
• • Patients with a history of smoking should not participate in this study.