Clinical trial NCT06304337: Application of New Oropharyngeal Airway Management in Patients Undergoing Painless Gastroenteroscopy
Official title: Randomized Controlled Clinical Study of the Incidence of Hypoxia in a Novel Oropharyngeal Airway During Painless Gastroenteroscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Airway Management
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study was to investigate the application of new oropharyngeal airway management in patients undergoing painless gastroenteroscopy.To see if it can really solve the problem of airway obstruction during anesthesia.The incidence of hypoxia (Spo2\<90%, t\>10s) and severe hypoxia (Spo2\<85%) during anesthesia and sedation, as well as the incidence of cough and laryngeal spasm, as well as the dose, endoscopist satisfaction, and the incidence of various adverse events were observed.To accumulate clinical experience and reference of anesthesia in obese patients.

Detailed description: Painless endoscopy is a popular method of endoscopic diagnosis and treatment.General intravenous anesthesia with propofol and fentanyl has been widely used in painless endoscopic diagnosis and treatment.However, the combined application of the two has an obvious respiratory central inhibitory effect, resulting in a decrease in blood oxygen saturation in patients, especially in obese and elderly patients, who are more prone to a sudden decrease in blood oxygen, and even life-threatening.Due to the potential risk of upper airway obstruction in some obese patients, intraoperative hypopnea may occur during painless colonoscopy due to sedative and analgesic drugs.Causing the patient to be starved of oxygen.At present, there is no special oropharyngeal ventilation device for gastroenteroscopy.In recent years, a new type of oropharyngeal ventilation channel has been developed and applied in clinic.Compared with the traditional nasal catheter, the new oropharyngeal airway nasal mask can better fit the patient's face, ensure the internal air tightness of the nose mask, and maximize the oxygen supply efficiency.Connecting the carbon dioxide outlet of the oral pharyngeal airway body can not only collect the exhaled gas of the patient, but also reduce the backflow of carbon dioxide gas.It can also be connected to a carbon dioxide detection device to monitor the partial pressure of carbon dioxide at the end of a patient's breath in real time.To evaluate whether a new type of oropharyngeal airway can reduce the incidence of hypoxia during painless gastroenteroscopy in general patients, the investigators present this study and investigate the safety and efficacy of the new type of oropharyngeal airway.

Eligibility criteria: Inclusion Criteria:Voluntary acceptance;Asa1-2 level;Age 18-95y;Mallampati grades Ⅰ or Ⅱ

Exclusion Criteria:

1. 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;
2. Severe cardiac insufficiency (\<4mets);
3. Patients with severe renal insufficiency (requiring dialysis before surgery);
4. Diagnosed severe liver insufficiency;
5. Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy;
6. Increased intracranial pressure;
7. Upper respiratory tract infections such as mouth, nose or throat;
8. Fever (core body temperature \>37.5 degrees Celsius);
9. a confirmed diagnosis of pregnancy or breastfeeding;
10. Allergic to sedatives such as propofol or equipment such as tape;
11. Emergency surgery;
12. Multiple trauma;
13. SpO2 \< 95% in preoperative breathing air;

Primary outcomes:
measure: Incidence of hypoxia (Spo2<90%,t>10s) and severe hypoxia (Spo2<85%) during anesthetic sedation
timeFrame: during surgery
Secondary outcomes:
measure: The incidence of choking, reflux aspiration and laryngeal spasm were recorded
timeFrame: during surgery
measure: The dose of additional drugs during the operation
timeFrame: during surgery
measure: Endoscopist satisfaction
timeFrame: within 30 minutes after surgery
measure: Record adverse events that occur throughout the process
timeFrame: during surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University（Qianfoshan Hospital, Shandong Province）
Study officials:
affiliation: Department director
name: Jianbo Wu
role: STUDY_DIRECTOR
References: