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Search / Trial NCT06590922

Application of New Oropharyngeal Airway Management in Obese Patients Undergoing Painless Gastroenteroscopy

Launched by QIANFOSHAN HOSPITAL · Sep 8, 2024

Trial Information

Current as of August 20, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new type of airway device designed to help obese patients breathe better during painless gastroenteroscopy, a procedure that examines the stomach and intestines. The traditional method of sedation used in these procedures can cause breathing problems, especially in obese patients, who may have difficulty getting enough oxygen. The new oropharyngeal airway is meant to improve airflow and reduce the risk of low oxygen levels, making the procedure safer for patients.

To participate in this trial, individuals must be between 18 and 65 years old, have a body mass index (BMI) between 30 and 40, and be able to give written consent. Participants will undergo painless gastroenteroscopy while using this new airway device. It’s important to note that certain health conditions, like severe lung or heart problems, or recent infections, may prevent someone from joining the study. Overall, this trial aims to ensure that obese patients have a safer experience during their medical procedures by testing a potentially better airway management tool.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 18-65 years
  • 30≤BMI≤40
  • Written informed consent of patient or family
  • painless stomach + colonoscopy
  • ASA grade I-II
  • Exclusion Criteria:
  • Patients with blood clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who cannot perform oropharyngeal airway ventilation;
  • Severe cardiac insufficiency (≤4mets);
  • Patients with severe renal insufficiency;
  • diagnosed severe hepatic insufficiency;
  • Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy;
  • Increased intracranial pressure;
  • 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 were excluded

About Qianfoshan Hospital

Qianfoshan Hospital is a leading medical institution dedicated to advancing healthcare through innovative clinical research and trials. Located in Shandong Province, China, the hospital is renowned for its commitment to excellence in patient care and medical education. With a multidisciplinary team of experienced professionals, Qianfoshan Hospital focuses on a wide range of therapeutic areas, striving to enhance treatment options and improve patient outcomes. The institution actively collaborates with various stakeholders to ensure the highest standards of ethics and efficacy in its clinical research endeavors.

Locations

Patients applied

0 patients applied

Trial Officials

Jianbo Wu

Principal Investigator

Department director

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported