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Search / Trial NCT06711328

Effect of New Oropharyngeal Airway on Incidence of Hypoxia During Painless Gastroenteroscopy in Elderly Patients

Launched by JIANBO WU · Nov 26, 2024

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of airway device designed to help elderly patients during painless gastroenteroscopy, a procedure used to examine the stomach and colon without causing discomfort. The goal is to see if this new device can reduce the risk of low oxygen levels, which can occur during the procedure, especially in older adults. Low oxygen levels can lead to serious complications and may require emergency interventions, so finding a safer way to manage breathing during these procedures is important.

To be eligible for this study, participants need to be between 65 and 80 years old and must be undergoing a painless gastroenteroscopy. They should be in generally good health, without serious breathing problems or conditions that would make it difficult to use the airway device. Participants will need to provide written consent, either themselves or through a family member. If chosen, they can expect to take part in a procedure that aims to improve their safety and comfort. It's important to note that individuals with certain medical conditions, recent infections, or those who smoke will not be eligible for this trial.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 65-80 years old
  • 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.

About Jianbo Wu

Jianbo Wu is a dedicated clinical trial sponsor committed to advancing medical research and therapeutic development. With a focus on innovative solutions, Jianbo Wu collaborates with healthcare professionals, research institutions, and regulatory bodies to design and implement rigorous clinical trials. The organization emphasizes ethical standards, patient safety, and scientific integrity, striving to bring cutting-edge treatments to market that address unmet medical needs. By harnessing a multidisciplinary approach and leveraging state-of-the-art methodologies, Jianbo Wu aims to contribute significantly to the healthcare landscape and improve patient outcomes across various therapeutic areas.

Locations

Patients applied

0 patients applied

Trial Officials

Jianbo Wu, Doctoral

Study Director

Department director

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported