Observation of Clinical Effect of New Oropharyngeal Airway in Patients With OSHAS During Painless Gastroenteroscopy

NCT06594380 | Not Yet Recruiting

• 1 other identifier: YXLL-KY-2024(084)
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

the(obstructivesleepapneahypoapneasyndromeOSAHS) is a kind of to sleep appear periodically in the process of syndrome characterized by partial or complete obstruction of upper respiratory tract.Patients with obstruction during the attack, faced with percutaneous arterial blood oxygen saturation (percutaneousarterialoxygensaturation, SpO2) to reduce the risk of can also trigger hypercapnia and cardiovascular dysfunction.The global incidence of OSAS is 4.0% in males and 2.0% in females .Sedative drugs inhibit the response of OSAS patients to external stimuli and may cause pharyngeal muscle collapse, leading to an increased risk of respiratory adverse events during painless gastroscopy in this population .In fact, OSAS has been identified as an independent risk factor for endoscopic hypoxia .Currently, there is no special oropharyngeal ventilation device used during gastroenteroscopy. Recently, a new type of oropharyngeal ventilation channel has been developed and applied in clinic.Compared with the conventional nasal catheter, the new oropharyngeal airway nasal mask can better fit the patient's face, ensure the air tightness inside the nose mask and maximize the oxygen supply efficiency. The carbon dioxide outlet connected to the oropharyngeal airway body can not only collect the patient's exhaled gas, but also reduce the backflow of carbon dioxide gas.It can also access carbon dioxide detection equipment to monitor the patient's PCO2 at the end of breath in real time .In order to evaluate whether the new oropharyngeal airway can reduce the incidence of hypoxia during painless gastroenteroscopy in general patients, the study was designed to investigate the safety and efficacy of the new oropharyngeal airway.

Conditions

OSAHS; Gastrointestinal Endoscopy; Airway Complication of Anesthesia

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

• The dosage of additional drugs was recorded during the operation

  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

In the new oropharyngeal airway group (experimental group), oxygen was continuously supplied through a catheter partially attached to the endoscopic bite before induction of anesthesia until the end of gastroenteroscopy

Device: Group using new oropharyngeal airway (experimental group)

The conventional endoscopic bite group was used

ACTIVE COMPARATOR

In the conventional endoscopic bite group (control group), oxygen was continuously supplied through a conventional nasal catheter before induction of anesthesia and until the end of gastroenteroscopy

Device: Endoscopic bite group (control group)

Interventions

Group using new oropharyngeal airway (experimental group) DEVICE

Before anesthesia induction, study participants in the experimental group received 5-6L/min oxygen for about 1min through an endoscopic bite oxygen supply device, and anesthesia induction was administered with propofol 3mg/kg and sufentanil 7μg.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. When participants achieved sufficient sedation (about BIS40), they were placed into the oropharyngeal airway through the endoscopic bite and began gastroscopy.Anesthetic maintenance was administered with a continuous pump of 5mg/kg·h propofol until completion of the examination

Using a new oropharyngeal airway set

Endoscopic bite group (control group) DEVICE

Prior to induction of anesthesia, control study participants inhaled 5 to 6L/min of oxygen through a nasal catheter for approximately 1 minute.Anesthesia was induced by propofol 3mg/kg and sufentanil 7μg.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. The endoscopic procedure began when the study participants reached sufficient sedation (about BIS40) and the ordinary endoscopic bite group reached sufficient sedation.Anesthetic maintenance was administered with a continuous pump of 5mg/kg·h propofol until completion of the examination.

The conventional endoscopic bite group was used

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old
• evidence of polysleep monitoring for diagnosis of OSAHS
• 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, Liu X, Meng Y, Zhu Y, Sun C, Wu J. Clinical effects of the use of a novel oropharyngeal airway in painless gastroscopy in patients with obstructive sleep apnoea-hypopnoea syndrome: a randomised controlled trial protocol. BMJ Open. 2026 Jan 27;16(1):e094885. doi: 10.1136/bmjopen-2024-094885.

  PMID: 41592820 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jianbo Wu

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianbo Wu, Doctorate

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Model Details: Using a new oropharyngeal airway set

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share