Application of New Oropharyngeal Airway Management in Patients Undergoing Painless Gastroenteroscopy

NCT ID: NCT06304337

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-03-03

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.

Conditions

Airway Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Ordinary oral cushion set

Before anesthesia induction, patients in the experimental group received 5-6L/min of oxygen for about 1min through the endoscopic bite connecting oxygen supply device, and patients in the control group inhaled 5-6L/min of oxygen for about 1min through the nasal catheter.Both groups were anesthetised with propofol 3mg/Kg and sufentanil 7ug.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. After the subjects achieved sufficient sedation (about BIS40), The ordinary endoscopic bite group began to perform endoscopic operation after sufficient sedation was achieved,In both groups, 5mg/Kg/h propofol was continuously pumped to maintain anesthesia until completion of the examination.

Group Type: NO_INTERVENTION

No interventions assigned to this group

New oropharyngeal airway group

Before anesthesia induction, patients in the experimental group received 5-6L/min of oxygen for about 1min through the endoscopic bite connecting oxygen supply device, and patients in the control group inhaled 5-6L/min of oxygen for about 1min through the nasal catheter.Both groups were anesthetised with propofol 3mg/Kg and sufentanil 7ug.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. After the subjects achieved sufficient sedation (about BIS40), the new oropharyngeal airway group was placed into the oropharyngeal airway through the endoscopic bite and then began gastroscopy,In both groups, 5mg/Kg/h propofol was continuously pumped to maintain anesthesia until completion of the examination

Group Type: EXPERIMENTAL

New oropharyngeal airway group

Intervention Type: DEVICE

Oropharyngeal airwayIt is composed of nasal plug, bite mouth, oropharyngeal passage, oxygen supply tube, rope and optional accessories carbon dioxide gas catheter and carbon dioxide collection tube.For patients undergoing endoscopic surgery/examination to prevent airway obstruction caused by backtongue fall, establish oropharyngeal airway for patients, and provide nasal oxygen at the same time, JK model can monitor oropharyngeal end-expiratory carbon dioxide collection.

Interventions

New oropharyngeal airway group

Oropharyngeal airwayIt is composed of nasal plug, bite mouth, oropharyngeal passage, oxygen supply tube, rope and optional accessories carbon dioxide gas catheter and carbon dioxide collection tube.For patients undergoing endoscopic surgery/examination to prevent airway obstruction caused by backtongue fall, establish oropharyngeal airway for patients, and provide nasal oxygen at the same time, JK model can monitor oropharyngeal end-expiratory carbon dioxide collection.

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianbo Wu

Role: STUDY_DIRECTOR

Department director

Locations

The First Affiliated Hospital of Shandong First Medical University（Qianfoshan Hospital, Shandong Province）

Jinan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianbo Wu

Role: CONTACT

312011097@qq.com

jianbowu@126.com

qi You

Role: CONTACT

jianbowu@126.com

312011097@qq.com

Facility Contacts

Qi You

Role: primary

312011097@qq.com

19553100910

Other Identifiers

YXLL-KY-2023(162)

Identifier Type: -

Identifier Source: org_study_id