Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment

Last updated: November 16, 2023
Sponsor: Sichuan Provincial People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Mask group

Routine nasal catheter group

Clinical Study ID

NCT06085859
endoscope mask-1
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To investigate the efficacy and safety of new-type mask compared with nasal tube oxygen delivery in patients undergoing sedation of upper gastrointestinal endoscopy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Upcoming upper gastrointestinal sedation procedure;
  3. Classification under the American Association of Anesthesiologists (ASA) status I-III;
  4. Baseline oxygen saturation (SpO2) ≥95% in ambient air conditions.

Exclusion

Exclusion Criteria:

  1. Individuals with previously documented difficulties in mask ventilation (DMV);
  2. Patients predisposed to aspiration risks or episodes of vomiting;
  3. Facial or jaw injuries or congenital abnormalities that render conventional face maskapplication infeasible;
  4. An inability or unwillingness to utilize the novel disposable anesthesia face mask.

Study Design

Total Participants: 1208
Treatment Group(s): 2
Primary Treatment: Mask group
Phase:
Study Start date:
October 18, 2023
Estimated Completion Date:
December 08, 2023

Study Description

This study aims to utilize a large sample, multicenter, prospective clinical trial using a new mask oxygen supply technology. If the study confirms that the new mask can improve the airway safety and effectiveness in patient examinations, while improving examination efficiency and reducing failure rates, it will provide safety assurance for the early diagnosis and treatment of upper gastrointestinal diseases in high-risk populations.

Connect with a study center

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • First People's Hospital of Liangshan Yi Autonomous Prefecture

    Liangshan, Sichuan
    China

    Active - Recruiting

  • Second People's Hospital of Yibin

    Yibin, Sichuan
    China

    Active - Recruiting

  • Ziyang People's Hospital

    Ziyang, Sichuan
    China

    Active - Recruiting

  • Chengdu Second People's Hospital

    Sichuan,
    China

    Active - Recruiting

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