Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Jianbo Wu

Conditions:

OSAHS

Gastrointestinal Endoscopy

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

the(obstructivesleepapneahypoapneasyndromeOSAHS) is a kind of to sleep appear periodically in the process of syndrome characterized by partial or complete obstruction of upper respiratory tract.Patien...

Detailed Description

1\. The study population was recruited by the principal investigator under strict control, and 130 patients with obstructive sleep apnea hypopnea syndrome (diagnosed as OSAHS by polysomnography monito...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2025

    Estimated Enrollment :

    130 Patients enrolled

    Trial Details

    Trial ID

    NCT06594380

    Start Date

    October 1 2024

    End Date

    December 1 2025

    Last Update

    September 19 2024

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