Observation of Clinical Effect of New Oropharyngeal Airway in Patients With OSHAS During Painless Gastroenteroscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJianbo Wu
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-65 years old
evidence of polysleep monitoring for diagnosis of OSAHS
written informed consent of patient or family member
painless stomach + colonoscopy
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
Group using new oropharyngeal airway (experimental group)
DeviceBefore 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
Endoscopic bite group (control group)
DevicePrior 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.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Using a new oropharyngeal airway setExperimental treatment 1 intervention
Group B: The conventional endoscopic bite group was usedActive comparator 1 intervention
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
The dosage of additional drugs was recorded during the operation
The dosage of additional drugs was recorded during the operation
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 is very satisfied.Patients are asked to select a number on the rating scale to indicate satisfaction with medical services or pain relief methods based on their actual experience
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
This trial is not recruiting at the moment. You can still explore other options: