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

Sichuan Provincial People's Hospital5 sites in 1 country1,208 target enrollmentOctober 18, 2023

ConditionsHypoxemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypoxemia
Sponsor: Sichuan Provincial People's Hospital
Enrollment: 1208
Locations: 5
Primary Endpoint: Incidence of hypoxemia
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 18, 2023

End Date

December 8, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sichuan Provincial People's Hospital

Responsible Party

Principal Investigator

Mengchang Yang

Principal Investigator

Sichuan Provincial People's Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Incidence of hypoxemia

Time Frame: From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.

Incidences of oxygen saturation falling below 92%

Secondary Outcomes

Juxtaposition of hypoxemia onset time in both ventilation techniques(From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.)
Inaugural insertion success rates in two groups of participants(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(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(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(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.)
the temporal span from initial decline to recovery to 92% saturation in both ventilation techniques(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(From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.)
Incidence of compromised ventilation mandating primary manual intervention(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(From the start of drug administration by the researcher to the completely withdraw from the endoscopy by the end of the examination.)
Satisfaction scores2 from patients, endoscopists, and anesthesiologists(Immediately after the procedure.)