Effect of New Oropharyngeal Airway on Incidence of Hypoxia During Painless Gastroenteroscopy in Elderly Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorJianbo Wu
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 65-80 years old
written informed consent of patient or family member
painless stomach + colonoscopy
ASA grade I-II
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
New oropharyngeal airway
DeviceThis 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
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: Using a new oropharyngeal airway setExperimental treatment 1 intervention
Group B: The conventional endoscopic bite groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The incidence of hypoxia
The incidence of hypoxia (75% ≤ SpO2 \< 90%, ≤ 60s)
Time frame
1 minute after anesthesia inductionSecondary outcomes
1
The incidence of severe hypoxia
The incidence of severe hypoxia (SpO2 \< 75% or 75% ≤SpO2 \< 90%, ≥60s)
Time frame
1 minute after anesthesia induction2
The incidence of requiring airway intervention
Tracheal intubation and noninvasive ventilation are required
Time frame
1 minute after anesthesia induction3
Cyclic fluctuation
Severe bradycardia (\< 50 beats/min), MAP fluctuation greater than 30% of the baseline value or MAP \< 60 mmHg
Time frame
1 minute after anesthesia induction4
The satisfaction of endoscopists was recorded
Patient satisfaction scales usually use a 0-10 scale, where 0 is very dissatisfied and 10
Time frame
Within 30 minutes after anesthesia awakeningLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jianbo Wu
Lead sponsor
Qianfoshan Hospital
Sponsor institution
Source ClinicalTrials.gov
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