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

NCT06711328 | Not Yet Recruiting

• 1 other identifier: YXLL-KY-2024(083)
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Airway Management; Elderly Patients

Outcome Measures

Primary Outcomes (1)

• The incidence of hypoxia

  The incidence of hypoxia (75% ≤ SpO2 \< 90%, ≤ 60s)

  1 minute after anesthesia induction

Secondary Outcomes (5)

• The incidence of severe hypoxia

  1 minute after anesthesia induction

• The incidence of requiring airway intervention

  1 minute after anesthesia induction

• Cyclic fluctuation

  1 minute after anesthesia induction

• The satisfaction of endoscopists was recorded

  Within 30 minutes after anesthesia awakening

• Recorded adverse events

  1 minute after anesthesia induction

Study Arms (2)

Using a new oropharyngeal airway set

EXPERIMENTAL

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

The conventional endoscopic bite group

NO INTERVENTION

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.

Interventions

New oropharyngeal airway DEVICE

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

Using a new oropharyngeal airway set

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jianbo Wu: lead

Related Publications (1)

• You Q, Meng Y, Liu X, Sun C, Wu J. Clinical efficacy of COMBO endoscopy of oropharyngeal airways in elderly patients undergoing painless gastroenteroscopy under anaesthesia: a randomized controlled trial protocol. BMC Anesthesiol. 2025 Sep 26;25(1):453. doi: 10.1186/s12871-025-03311-8.

  PMID: 41013276 DERIVED

Study Officials

• Jianbo Wu, Doctoral

  Department director

  STUDY DIRECTOR

Central Study Contacts

Jianbo Wu, Doctoral

CONTACT

18560083793; jianbowu@126.com

Qi You, Master

CONTACT

19553100910; 312011097@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: February 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share