Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594380
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
Observation of Clinical Effect of New Oropharyngeal Airway in Patients With OSHAS During Painless Gastroenteroscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Observation of Clinical Effect of New Oropharyngeal Airway in Patients With Obstructive Sleep Apnea Hypoapnea Syndrome During 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:
theobstructivesleepapneahypoapneasyndromeOSAHS is a kind of to sleep appear periodically in the process of syndrome characterized by partial or complete obstruction of upper respiratory tractPatients 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 dysfunctionThe global incidence of OSAS is 40 in males and 20 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 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 during painless gastroenteroscopy in general patients the study was designed to investigate the safety and efficacy of the new oropharyngeal airway
Detailed Description:
1 The study population was recruited by the principal investigator under strict control and 130 patients with obstructive sleep apnea hypopnea syndrome diagnosed as OSAHS by polysomnography monitoring who underwent painless gastroenteroscopy since the same day were selected They were informed and agreed to this clinical trial2 Sample size calculationAccording to the pre-test results the incidence of hypoxia in the test group and the control group were 02 and 05 respectively The sample size was calculated using PASS software and the bilateral test level α005 and the test efficacy power09 were set 52 cases were required in each group according to the incidence of hypoxia and 65 cases in each group were calculated after considering 20 shedding rate totaling 130 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 IPI composite lung index 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 planned to implement simple randomization using SAS 1 The group using the new oropharyngeal airway test group Oxygen was continuously supplied through a catheter partially attached to the endoscopic mouth 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 trialBefore 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 1min later When participants achieved sufficient sedation about BIS40 the new oropharyngeal airway group was placed into the oropharyngeal airway through the endoscopic bite and then began gastroscopyThe 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