Clinical trial NCT06085859: Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment
Official title: Anesthesia Endoscope Mask is Applied to Sedation Upper Gastrointestinal Endoscopic Diagnosis and Treatment: Multi-center, Prospective, Randomized Control, Open Clinical Research
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxemia
Keywords: hypoxemia
sedation
gastrointestinal sedation procedure
non-invasive ventilation
endoscopy mask
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Anhui Sanhong Medical Device Technology Co., Ltd
First posted: 2023-10-17
Enrollment: 1208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomly assign participants to the standard nasal catheter oxygenation group and the endoscopy mask oxygen inhalation group
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Incidence of hypoxemia
timeFrame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Secondary outcomes:
measure: Incidence of compromised ventilation mandating primary manual intervention
timeFrame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
measure: Incidence necessitating sophisticated manual ventilatory support during pain-free gastroscopy
timeFrame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
measure: Juxtaposition of hypoxemia onset time in both ventilation techniques
timeFrame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
measure: the temporal span from initial decline to recovery to 92% saturation in both ventilation techniques
timeFrame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
measure: the lowest oxygen saturation in both ventilation techniques
timeFrame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
measure: Evaluation of procedural prolongation due to ventilation issues
timeFrame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
measure: Apnea prevalence in both groups
timeFrame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
measure: Satisfaction scores1 from patients, endoscopists, and anesthesiologists
timeFrame: Immediately after the procedure.
measure: Satisfaction scores2 from patients, endoscopists, and anesthesiologists
timeFrame: Immediately after the procedure.
measure: The incidence of upper respiratory tract discomfort manifestations such as oral, nasal, an pharyngeal dryness and hemorrhage in two groups of participants.
timeFrame: Immediately after the procedure.
measure: Inaugural insertion success rates in two groups of participants
timeFrame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Liangshan
country: China
facility: First People's Hospital of Liangshan Yi Autonomous Prefecture
state: Sichuan
city: Yibin
country: China
facility: Second People's Hospital of Yibin
state: Sichuan
city: Ziyang
country: China
facility: Ziyang People's Hospital
state: Sichuan
city: Sichuan
country: China
facility: Chengdu Second People's Hospital
Study officials:
References:
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