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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hypoxemia
• Intervention / Treatment: Device: Mask group; Device: Routine nasal catheter group

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 Type: Interventional
• Enrollment (Estimated): 1208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan, China
    • Recruiting
    • Chengdu Second People's Hospital
    • Contact: Shaoxing Liu; Phone Number: +8618030611589; Email: liu110022@126.com
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Mengchang Yang, Doctor; Phone Number: +8618140049936; Email: ymc681@126.com
    • Liangshan, Sichuan, China
      • Recruiting
      • First People's Hospital of Liangshan Yi Autonomous Prefecture
      • Contact: Xiang Shen; Phone Number: 18981561217; Email: 455517537@qq.com
    • Yibin, Sichuan, China
      • Recruiting
      • Second People's Hospital of Yibin
      • Contact: Jinghua Ren; Phone Number: 15351350950; Email: 272171373@qq.com
    • Ziyang, Sichuan, China
      • Recruiting
      • Ziyang People's Hospital
      • Contact: Xinquan Liu; Phone Number: 15892348079; Email: 1355302984@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal oxygen supply 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	Device: Routine nasal catheter group; 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
Experimental: Mask oxygen supply group; 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; 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

What is the study measuring?

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.
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.
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.

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital
• Collaborators: Anhui Sanhong Medical Device Technology Co., Ltd

Publications and helpful links

General Publications

• Terblanche NCS, Middleton C, Choi-Lundberg DL, Skinner M. Efficacy of a new dual channel laryngeal mask airway, the LMA(R)Gastro Airway, for upper gastrointestinal endoscopy: a prospective observational study. Br J Anaesth. 2018 Feb;120(2):353-360. doi: 10.1016/j.bja.2017.11.075. Epub 2017 Dec 1.
• Behrens A, Kreuzmayr A, Manner H, Koop H, Lorenz A, Schaefer C, Plauth M, Jetschmann JU, von Tirpitz C, Ewald M, Sackmann M, Renner W, Kruger M, Schwab D, Hoffmann W, Engelke O, Pech O, Kullmann F, Pampuch S, Lenfers B, Weickert U, Schilling D, Boehm S, Beckebaum S, Cicinnati V, Erckenbrecht JF, Dumoulin FL, Benz C, Rabenstein T, Haltern G, Balsliemke M, de Mas C, Kleber G, Pehl C, Vogt C, Kiesslich R, Fischbach W, Koop I, Kuehne J, Breidert M, Sass NL, May A, Friedrich C, Veitt R, Porschen R, Ellrichmann M, Arlt A, Schmitt W, Dollhopf M, Schmidbaur W, Dignass A, Schmitz V, Labenz J, Kaiser G, Krannich A, Barteska N, Ell C. Acute sedation-associated complications in GI endoscopy (ProSed 2 Study): results from the prospective multicentre electronic registry of sedation-associated complications. Gut. 2019 Mar;68(3):445-452. doi: 10.1136/gutjnl-2015-311037. Epub 2018 Jan 3.
• Nay MA, Fromont L, Eugene A, Marcueyz JL, Mfam WS, Baert O, Remerand F, Ravry C, Auvet A, Boulain T. High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial). Br J Anaesth. 2021 Jul;127(1):133-142. doi: 10.1016/j.bja.2021.03.020. Epub 2021 Apr 28.
• Goudra B, Nuzat A, Singh PM, Borle A, Carlin A, Gouda G. Association between Type of Sedation and the Adverse Events Associated with Gastrointestinal Endoscopy: An Analysis of 5 Years' Data from a Tertiary Center in the USA. Clin Endosc. 2017 Mar;50(2):161-169. doi: 10.5946/ce.2016.019. Epub 2016 Apr 29.
• Qin Y, Li LZ, Zhang XQ, Wei Y, Wang YL, Wei HF, Wang XR, Yu WF, Su DS. Supraglottic jet oxygenation and ventilation enhances oxygenation during upper gastrointestinal endoscopy in patients sedated with propofol: a randomized multicentre clinical trial. Br J Anaesth. 2017 Jul 1;119(1):158-166. doi: 10.1093/bja/aex091.
• Bell GD, Bown S, Morden A, Coady T, Logan RF. Prevention of hypoxaemia during upper-gastrointestinal endoscopy by means of oxygen via nasal cannulae. Lancet. 1987 May 2;1(8540):1022-4. doi: 10.1016/s0140-6736(87)92282-3.
• King AB, Alvis BD, Hester D, Taylor S, Higgins M. Randomized trial of a novel double lumen nasopharyngeal catheter versus traditional nasal cannula during total intravenous anesthesia for gastrointestinal procedures. J Clin Anesth. 2017 May;38:52-56. doi: 10.1016/j.jclinane.2017.01.025. Epub 2017 Jan 22.
• Hung KC, Chang YJ, Chen IW, Soong TC, Ho CN, Hsing CH, Chu CC, Chen JY, Sun CK. Efficacy of high flow nasal oxygenation against hypoxemia in sedated patients receiving gastrointestinal endoscopic procedures: A systematic review and meta-analysis. J Clin Anesth. 2022 May;77:110651. doi: 10.1016/j.jclinane.2022.110651. Epub 2022 Jan 12.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 8, 2023

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: sedation; non-invasive ventilation; hypoxemia; gastrointestinal sedation procedure; endoscopy mask
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: endoscope mask-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After December 2024, the original data can be obtained through the author's email address.
• IPD Sharing Time Frame: After December 2024
• IPD Sharing Access Criteria: Any project applicant
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No