Effect of New Oropharyngeal Airway on Incidence of Hypoxia During Painless Gastroenteroscopy in Elderly Patients

With the aging of Chinese population, the early screening of gastrointestinal diseases and the promotion and implementation of comfortable medical treatment, more and more elderly patients choose painless gastroenteroscopy for diagnosis and treatment.However, the incidence of anesthesia-related adverse reactions and complications is high in elderly patients.Hypoxemia caused by anesthetic-induced respiratory depression and airway obstruction is a serious complication in painless gastroenteroscopy.Severe hypoxemia not only requires emergency airway intervention, such as mask ventilation or even tracheal intubation, but also leads to the interruption of endoscopic diagnosis and treatment.Advanced age was an independent risk factor for hypoxemia during painless gastroenteroscopy,This study observed the effect of a new type of oropharyngeal ventilation in improving the elderly painless gastroenteroscopy anesthesia hypoxemia and reducing intraoperative airway intervention, so as to evaluate the safety and effectiveness of a new type of nasopharyngeal ventilation in the elderly painless gastrointestinal diagnosis and treatment, and provide clinical reference.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Management; Elderly Patients
• Intervention / Treatment: Device: New oropharyngeal airway

Detailed Description

The oropharyngeal airway is an important airway auxiliary device for short-term airway management during the perianesthetic period, which can provide patients with an unobstructed airway during autonomous ventilation .The oropharyngeal vent has been proven to be successfully used in infants, the elderly and MRI, and can be used in short outpatient surgery instead of laryngeal mask .The oropharyngeal airway has a low incidence of pharyngeal trauma and laryngeal pain immediately after surgery, requiring a shorter exposure time of inhaled anesthetic and a lower concentration of propofol to successfully place it .During the operation to preserve spontaneous breathing, the oropharyngeal airway is introduced as a ventilation device .The new oropharyngeal airway can accept the implantation of gastroscopy and provide oxygen to patients without affecting the operation at the same time. In order to explore whether the new oropharyngeal airway can provide better oxygen to patients undergoing painless gastroenteroscopy and reduce the incidence of hypoxia during the operation, we have drafted this study and explored the safety of the new oropharyngeal airway in painless gastroenteroscopy.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianbo Wu, Doctoral; Phone Number: 18560083793; Email: jianbowu@126.com
• Study Contact Backup: Name: Qi You, Master; Phone Number: 19553100910; Email: 312011097@qq.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age 65-80 years old
• written informed consent of patient or family member
• painless stomach + colonoscopy
• ASA grade I-II

Exclusion Criteria:

• Patients with clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who could not perform oropharyngeal airway ventilation;
• Upper respiratory tract infections such as mouth, nose or throat;
• Fever (core body temperature ≥37.5℃);
• a confirmed diagnosis of pregnancy or breastfeeding;
• Allergic to sedatives such as propofol or equipment such as tape;
• Emergency surgery;
• Multiple trauma;
• SpO2 < 95% before operation;
• A history of drug and/or alcohol abuse within 2 years prior to the start of the screening period;(Drinking more than three times standard alcoholic beverages per day, equivalent to about 10g of alcohol or equivalent to 50g of Chinese liquor);
• Patients with previous psychiatric and neurological diseases, such as depression, severe central nervous depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis;
• Currently participating in other clinical trials;
• Patients who are deemed unfit by the investigator to participate in the trial;
• Patients with a history of smoking should not participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Using a new oropharyngeal airway set; Study participants entered the examination room to establish intravenous access, using 2% lidocaine gel 5ml containing mouth cavity and pharynx.Heart rate (HR), pulse oxygen saturation (SpO2), end-expiratory carbon dioxide, ECG monitoring, and non-invasive blood pressure (measured every 2.5 minutes) were routinely monitored before anesthesia induction.Study participants were asked to lie on their left side.In this study, the relevant staff of the undergraduate department participating in this clinical trial planned to implement simple randomization using SAS: The group using the new oropharyngeal airway (trial group) : Oxygen was continuously supplied through a catheter partially connected to the endoscopic mouth before induction of anesthesia until the end of gastroenteroscopy	Device: New oropharyngeal airway; This product is produced and sold by Shanghai Elifu Medical Technology Co., LTD., and has been officially put into clinical use in March 2023.The product is named oropharyngeal airway for disposable endoscope, which is composed of nasal plug, bite, oropharyngeal channel, oxygen supply tube, lanyard and optional accessories carbon dioxide gas catheter and carbon dioxide collection tube.The model used in this study is JK (Oropharyngeal airway for endoscope with end-expiratory carbon dioxide Collection) with L/M/S three specifications, which is used to prevent airway obstruction caused by backward tongue fall during endoscopic surgery/examination, establish oropharyngeal airway for patients, and provide nasal oxygen at the same time
No Intervention: The conventional endoscopic bite group; Study participants entered the examination room to establish intravenous access, using 2% lidocaine gel 5ml containing mouth cavity and pharynx.Heart rate (HR), pulse oxygen saturation (SpO2), end-expiratory carbon dioxide, ECG monitoring, and non-invasive blood pressure (measured every 2.5 minutes) were routinely monitored before anesthesia induction.Study participants were asked to lie on their left side.In this study, the relevant staff of the undergraduate department participating in this clinical trial planned to implement simple randomization using SAS:In the conventional endoscopic bite group (control group), oxygen was continuously supplied through a common nasal catheter before induction of anesthesia until the end of gastroenteroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of hypoxia	The incidence of hypoxia (75% ≤ SpO2 < 90%, ≤ 60s)	1 minute after anesthesia induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of severe hypoxia	The incidence of severe hypoxia (SpO2 < 75% or 75% ≤SpO2 < 90%, ≥60s)	1 minute after anesthesia induction
The incidence of requiring airway intervention	Tracheal intubation and noninvasive ventilation are required	1 minute after anesthesia induction
Cyclic fluctuation	Severe bradycardia (< 50 beats/min), MAP fluctuation greater than 30% of the baseline value or MAP < 60 mmHg	1 minute after anesthesia induction
The satisfaction of endoscopists was recorded	Patient satisfaction scales usually use a 0-10 scale, where 0 is very dissatisfied and 10	Within 30 minutes after anesthesia awakening
Recorded adverse events	The incidence of choking, laryngeal spasm and reflux aspiration were observed.Apnea or slow breathing episodes (defined as respiratory rate ≤6 beats/min);Bradycardia is defined as a heart rate ≤50 beats/min.Serious adverse events such as tracheal intubation, non-invasive ventilation, use of vasopressors, and hospitalization are required.	1 minute after anesthesia induction

Collaborators and Investigators

• Sponsor: Jianbo Wu
• Investigators: Study Director: Jianbo Wu, Doctoral, Department Director

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: YXLL-KY-2024(083)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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