Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06590922
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
Application of New Oropharyngeal Airway Management in Obese Patients Undergoing Painless Gastroenteroscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Application of New Oropharyngeal Airway Management in Obese Patients Undergoing Painless Gastroenteroscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 treatmentHowever 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 clinicCompared with the conventional nasal catheter the new oropharyngeal airway nasal mask can better fit the patients 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 patients exhaled gas but also reduce the backflow of carbon dioxide gasIt can also access carbon dioxide detection equipment to monitor the patients 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
Detailed Description:
1 The study population was recruited by the investigator participating in the clinical trial under the control of the principal investigator 226 obese patients 30BMI40 who had undergone painless gastroenteroscopy since the same day were selected and informed and consented to the clinical trial2 Sample size calculationAccording to the pre-test results of obese people the incidence of hypoxia in the test group and the control group was 008 and 026 respectively The sample size was calculated using PASS software and the bilateral test level α005 was set and the test efficacy power09 was set According to the incidence of hypoxia 90 cases were required in each group and 113 cases in each group were calculated after considering 20 shedding rateA total of 226 cases3 Specific study contents Study participants entered the examination room to establish venous access and used 2 lidocaine gel 5ml containing mouthwash and pharynxHeart rate HR pulse oxygen saturation SpO2 end-expiratory carbon dioxide ECG monitoring and non-invasive blood pressure measured every 25 minutes were routinely monitored before anesthesia inductionAsk patient to lie on left sideIn this study the investigators participating in this clinical trial plan to implement simple randomization using SAS 1 The group using the new oropharyngeal airway trial group Oxygen is continuously supplied through a catheter partially attached to the endoscopic bite before induction of anesthesia until the end of gastroenteroscopy2 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 gastroenteroscopyThe entire trial operation process was completed by the investigators participating in the clinical studyBefore induction of anesthesia study participants in the experimental group received 5-6Lmin of oxygen for about 1 minute through an endoscopic biting oxygen supply device and participants in the control group inhaled 5-6Lmin of oxygen for about 1 minute through a nasal catheterPropofol 3mgkg and sufentanil 7μg were used to induce anesthesia in both groupsSufentanil was given at the beginning of pre-oxygen inhalation and propofol was given 1 minute later When participants achieved sufficient sedation BIS40 left and 12 right the new oropharyngeal airway group was placed into the oropharyngeal airway through the endoscopic bite and then gastroscopy was performedThe ordinary endoscopic bite group began to perform endoscopic operation after sufficient sedation was achievedIn both groups 5mgkgh propofol was injected continuously to maintain anesthesia until the examination was completedIf participants showed frowning or slight body movement during diagnosis and treatment 40 to 50mg of propofol was added intravenouslyIf HR 50 timesintravenous injection of atropine 05mgMAP 60mmHg intravenous hydroxyamine 1mgWhen SpO2 92 artificial airway intervention such as jaw support assisted breathing or mask was givenAfter the examination study participants were not allowed to leave the examination room until they had a MOAAS score of 3-4If the sedationanaesthesia Discharge rating scale scores more than 9 points patients can be accompanied by relatives and friendsThe incidence of hypoxia 75SpO2 90 60s and severe hypoxia SpO2 75 or 75SpO2 90 60s during anesthesia were recordedThe incidence of choking reflux aspiration and laryngeal spasm were recordedThe time of intervention was half or disappearance of end-expiratory carbon dioxide andor disappearance of thoracic fluctuation andor SpO2 95 that is opening the airway successively until SpO295 and recording the last means of opening the airwayThe means of opening the airway of the two groups were the same including 1 adjusting the oxygen flow2 Lift the lower jaw3 Mask ventilation pull out the gastroscope if necessary4 Tracheal intubation or laryngeal mask for ventilator assisted ventilation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None