An interventional study of New oropharyngeal airway in Airway Management and Elderly Patients, sponsored by Jianbo Wu. Not yet recruiting. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Jianbo Wu · Not applicable, Interventional, and Prevention
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.
The oropharyngeal airway is an important airway auxiliary device for short-term airway management during the perianesthetic period, which can provide patients with an unobstructed airway during autonomous ventilation .The oropharyngeal vent has been proven to be successfully used in infants, the elderly and MRI, and can be used in short outpatient surgery instead of laryngeal mask .The oropharyngeal airway has a low incidence of pharyngeal trauma and laryngeal pain immediately after surgery, requiring a shorter exposure time of inhaled anesthetic and a lower concentration of propofol to successfully place it .During the operation to preserve spontaneous breathing, the oropharyngeal airway is introduced as a ventilation device .The new oropharyngeal airway can accept the implantation of gastroscopy and provide oxygen to patients without affecting the operation at the same time. In order to explore whether the new oropharyngeal airway can provide better oxygen to patients undergoing painless gastroenteroscopy and reduce the incidence of hypoxia during the operation, we have drafted this study and explored the safety of the new oropharyngeal airway in painless gastroenteroscopy.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's planned enrollment of 164 is above the median of 45 across 853 interventional studies indexed under Hypoxia.
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Exclusion Criteria:
Study participants entered the examination room to establish intravenous access, using 2% lidocaine gel 5ml containing mouth cavity and pharynx.Heart rate (HR), pulse oxygen saturation (SpO2), end-expiratory carbon dioxide, ECG monitoring, and non-invasive blood pressure (measured every 2.5 minutes) were routinely monitored before anesthesia induction.Study participants were asked to lie on their left side.In this study, the relevant staff of the undergraduate department participating in this clinical trial planned to implement simple randomization using SAS: The group using the new oropharyngeal airway (trial group) : Oxygen was continuously supplied through a catheter partially connected to the endoscopic mouth before induction of anesthesia until the end of gastroenteroscopy
Device: New oropharyngeal airway
Study participants entered the examination room to establish intravenous access, using 2% lidocaine gel 5ml containing mouth cavity and pharynx.Heart rate (HR), pulse oxygen saturation (SpO2), end-expiratory carbon dioxide, ECG monitoring, and non-invasive blood pressure (measured every 2.5 minutes) were routinely monitored before anesthesia induction.Study participants were asked to lie on their left side.In this study, the relevant staff of the undergraduate department participating in this clinical trial planned to implement simple randomization using SAS: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 gastroenteroscopy.
This 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
The incidence of hypoxia
The incidence of hypoxia (75% ≤ SpO2 \< 90%, ≤ 60s)
Time frame: 1 minute after anesthesia induction
The incidence of severe hypoxia
The incidence of severe hypoxia (SpO2 \< 75% or 75% ≤SpO2 \< 90%, ≥60s)
Time frame: 1 minute after anesthesia induction
The incidence of requiring airway intervention
Tracheal intubation and noninvasive ventilation are required
Time frame: 1 minute after anesthesia induction
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 induction
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 awakening
Recorded adverse events
The incidence of choking, laryngeal spasm and reflux aspiration were observed.Apnea or slow breathing episodes (defined as respiratory rate ≤6 beats/min);Bradycardia is defined as a heart rate ≤50 beats/min.Serious adverse events such as tracheal intubation, non-invasive ventilation, use of vasopressors, and hospitalization are required.
Time frame: 1 minute after anesthesia induction
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Jianbo Wu