Application of New Oropharyngeal Airway Management in Obese Patients Undergoing Painless Gastroenteroscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorQianfoshan Hospital
About this trial
Painless endoscopy is a popular method of endoscopic diagnosis and treatment. Propofol combined with fentanyl general intravenous anesthesia has been widely used in painless endoscopic diagnosis and treatment.However, the combined application of the two has a significant respiratory center inhibition effect, resulting in a decrease in blood oxygen saturation of patients, especially obese patients, who are more likely to suffer from a sudden drop in blood oxygen and even threaten their lives .Due to the potential risk of upper airway obstruction in some obese patients, intraoperative hypopnea may occur during painless colonoscopy due to the influence of sedative and analgesic drugs, resulting in hypoxia in patients. In addition, the anatomical and pathological changes of obese patients themselves make hypoxia tolerance poor and airway establishment difficult, which may endanger the safety of patients .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 in ordinary patients during painless gastroenteroscopy, the investigators prepared this study and explored the safety and effectiveness of the new oropharyngeal airway .
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-65 years
30≤BMI≤40
Written informed consent of patient or family
painless stomach + colonoscopy
Disqualifiers
Patients with blood clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who cannot perform oropharyngeal airway ventilation;
Severe cardiac insufficiency (≤4mets);
Patients with severe renal insufficiency;
diagnosed severe hepatic insufficiency;
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.
The conventional endoscopic biting 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
226 Participants
are divided into 2 treatment groupsGroup A: Using a new oropharyngeal airway setExperimental treatment 1 intervention
Group B: The conventional endoscopic bite groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of hypoxia
To investigate the incidence of new oropharyngeal airway hypoxia (75%≤SpO2 \< 90%, ≤60s) during anesthesia in patients undergoing painless gastroenteroscopy
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
Serious adverse events such as tracheal intubation, non-invasive 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
The doctor satisfaction rating scale also uses a 0-10 rating scale, where 0 represents very dissatisfied and 10 represents very satisfied. Endoscopes need to select a corresponding number on the scoring table based on their actual experience to indicate whether the patient is satisfied with the patient's cooperation and response to the operation process.
Time frame
Within 30 minutes after anesthesia awakeningLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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