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

Sichuan Provincial People's Hospital

Status: Enrolling

Conditions: Hypoxemia

Treatments: Device: Mask group; Device: Routine nasal catheter group

Study type: Interventional

Funder types: Other

Identifiers

NCT06085859

endoscope mask-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,208 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,208 participants in 2 patient groups

Mask oxygen supply group

Experimental group

Description:

The anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter

Treatment:

Device: Mask group

Nasal oxygen supply group

Experimental group

Description:

The study team applied the mask with a head strap to ensure a proper seal,simultaneously ensuring the same oxygen flow rate as the control group

Treatment:

Device: Routine nasal catheter group