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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypoxemia

Intervention / Treatment
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* Device: Routine nasal catheter group
* Device: Mask group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; Upcoming upper gastrointestinal sedation procedure; Classification under the American Association of Anesthesiologists (ASA) status I-III; Baseline oxygen saturation (SpO2) ≥95% in ambient air conditions. Exclusion Criteria: Individuals with previously documented difficulties in mask ventilation (DMV); Patients predisposed to aspiration risks or episodes of vomiting; Facial or jaw injuries or congenital abnormalities that render conventional face mask application infeasible; An inability or unwillingness to utilize the novel disposable anesthesia face mask.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomly assign participants to the standard nasal catheter oxygenation group and the endoscopy mask oxygen inhalation group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mask oxygen supply group<br>The anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter | Device: Mask group<br>* 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<br>|
| Experimental: Nasal oxygen supply group<br>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 | Device: Routine nasal catheter group<br>* The anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter as described in the guide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoxemia | Incidences of oxygen saturation falling below 92% | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of compromised ventilation mandating primary manual intervention | For the nasal catheter cohort, this entailed jaw elevation and deploying a standard mask to augment the oxygen concentration inhaled. Concurrently, for the mask cohort, primary intervention involved mandible lifting and secure fastening of the mask sleeve for inflation (while ensuring the operational aperture remains sealed). | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | 
| Incidence necessitating sophisticated manual ventilatory support during pain-free gastroscopy | If SpO2 levels further descended to ≤70% or persistently hovered below 85% for a duration exceeding 60 seconds, it mandated an immediate cessation of the ongoing procedure. The endoscope would be retracted, followed by the insertion of a standard oropharyngeal mask for assisted ventilation. In dire circumstances, the anesthesiologist might opt for advanced airway interventions, such as laryngeal mask application or endotracheal intubation. | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | 
| Juxtaposition of hypoxemia onset time in both ventilation techniques | The time span from the start of drug administration by the researcher to the first occurrence of blood oxygen saturation below 92%. | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | 
| the temporal span from initial decline to recovery to 92% saturation in both ventilation techniques | The time span from oxygen saturation below 92% to recovery to 92% after manual ventilatory support. If multiple episodes of hypoxia occur, all times will be added up | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | 
| the lowest oxygen saturation in both ventilation techniques | the lowest oxygen saturation from the start of medication administration to the participants's Aldrete score of 9. | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | 
| Evaluation of procedural prolongation due to ventilation issues | The extension time for examination is defined as the total time from stopping the operation and exiting the endoscope until the endoscope re-enters the digestive tract, to the same anatomical position before stopping the operation, If multiple episodes of withdrawal of endoscopy occur, all times will be added up | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | 
| Apnea prevalence in both groups | The study here we define apnea as 10 second without obvious respiratory movements of mesothorax and abdomen or snoring with paradoxical breathing | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | 
| Satisfaction scores1 from patients, endoscopists, and anesthesiologists | The scores of satisfaction 1：Are you satisfied with this endoscopic diagnosis and treatment,a score of 0 represents very dissatisfied, while a score of 10 represents very satisfied. | Immediately after the procedure. | 
| Satisfaction scores2 from patients, endoscopists, and anesthesiologists | The scores of satisfaction2：If there is a chance, are you willing to use this non-invasive oxygen device again,a score of 0 indicates a strong unwillingness, while a score of 10 indicates a strong willingness. | Immediately after the procedure. | 
| The incidence of upper respiratory tract discomfort manifestations such as oral, nasal, an pharyngeal dryness and hemorrhage in two groups of participants. |  | Immediately after the procedure. | 
| Inaugural insertion success rates in two groups of participants | If the endoscopic operation fails to pass the pharynx after three attempts, recorded as the first insertion failure. | From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypoxemia, sedation, gastrointestinal sedation procedure, non-invasive ventilation, endoscopy mask