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Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment | Clinical Trials | Clareo Health

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

Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment: Multi-center, Prospective, Randomized Control, Open Clinical Research

NCT06085859•Sichuan Provincial People's Hospital

View on ClinicalTrials.gov

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

Detailed 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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

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 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 mask application infeasible;
•4. An inability or unwillingness to utilize the novel disposable anesthesia face mask.

Locations (5)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

First People's Hospital of Liangshan Yi Autonomous Prefecture

Liangshan, Sichuan, China

Second People's Hospital of Yibin

Yibin, Sichuan, China

Ziyang People's Hospital

Ziyang, Sichuan, China

Chengdu Second People's Hospital

Sichuan, China

Key Dates

Start Date

October 18, 2023

Primary Completion Date

December 1, 2023

Completion Date

December 8, 2023

Last Updated

November 18, 2023

Enrollment

1,208

ESTIMATED participants

Conditions

Hypoxemia

Interventions

Routine nasal catheter group

DEVICE

Mask group

DEVICE

Health Systems and Policy Contexts of Medical Oxygen

NCT06169514

HypoxemiaMorality+1 more

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RECRUITINGNA

Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)

NCT06432881

Hypoxemia

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Health Systems and Policy Contexts of Medical Oxygen

Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)

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