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

Not Applicable

Recruiting

• Conditions: Hypoxemia
• Interventions: Device: Mask group; Device: Routine nasal catheter group

• Registration Number: NCT06085859
• Lead Sponsor: Sichuan Provincial People's Hospital

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.

Study Timeline

• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-17
• Study Start: 2023-10-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mask oxygen supply group	Mask group	The anaesthesia provider supplied oxygen via a nasal cannula at an oxygen flow rate of 8 Litres/minute supplied from an oxygen flowmeter
Nasal oxygen supply group	Routine nasal catheter group	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

Primary Outcome Measures

Name	Time	Method
Incidence of hypoxemia	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 Outcome Measures

Name	Time	Method
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.	The time span from the start of drug administration by the researcher to the first occurrence of blood oxygen saturation below 92%.
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.	If the endoscopic operation fails to pass the pharynx after three attempts, recorded as the first insertion failure.
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.	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
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.	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.
Satisfaction scores1 from patients, endoscopists, and anesthesiologists	Immediately after the procedure.	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.
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.	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
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.	The study here we define apnea as 10 second without obvious respiratory movements of mesothorax and abdomen or snoring with paradoxical breathing
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.	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).
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.	the lowest oxygen saturation from the start of medication administration to the participants's Aldrete score of 9.
Satisfaction scores2 from patients, endoscopists, and anesthesiologists	Immediately after the procedure.	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.

Trial Locations

Locations (5)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China

Chengdu Second People's Hospital; 🇨🇳 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