Application of New Oropharyngeal Airway Management in Obese Patients Undergoing Painless Gastroenteroscopy

NCT06590922 | Not Yet Recruiting

• 1 other identifier: YXLL-KY-2024 (082)
• Study Type: interventional
• Target: 226
• Locations: 0 countries
• Sites: N/A

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 treatment.However, 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 clinic.Compared with the conventional nasal catheter, the new oropharyngeal airway nasal mask can better fit the patient's 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 patient's exhaled gas, but also reduce the backflow of carbon dioxide gas.It can also access carbon dioxide detection equipment to monitor the patient's 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 .

Conditions

Obesity; Gastrointestinal Endoscopy; Airway Management

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxia

  To investigate the incidence of new oropharyngeal airway hypoxia (75%≤SpO2 \< 90%, ≤60s) during anesthesia in patients undergoing painless gastroenteroscopy

  1 minute after anesthesia induction

Secondary Outcomes (5)

• The incidence of severe hypoxia

  1 minute after anesthesia induction

• The incidence of requiring airway intervention

  1 minute after anesthesia induction

• The dosage of additional drugs was recorded during the operation

  1 minute after anesthesia induction

• The satisfaction of endoscopists was recorded

  Within 30 minutes after anesthesia awakening

• Recorded adverse events

  1 minute after anesthesia induction

Study Arms (2)

Using a new oropharyngeal airway set

EXPERIMENTAL

Prior to induction of anesthesia and until the end of the gastroenteroscopy, oxygen was continuously supplied through a catheter partially attached to the endoscopic bite.

Device: Group using new oropharyngeal airway (experimental group)

The conventional endoscopic bite group

ACTIVE COMPARATOR

Oxygen was administered continuously through a common nasal catheter until the end of the gastroenteroscopy prior to induction of anesthesia

Device: The conventional endoscopic biting group (control group)

Interventions

Group using new oropharyngeal airway (experimental group) DEVICE

Before anesthesia induction, study participants in the experimental group received 5-6L/min oxygen for about 1min through an endoscopic bite oxygen supply device, and anesthesia induction was administered with propofol 3mg/kg and sufentanil 7μg.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. When participants achieved sufficient sedation (about BIS40), they were placed into the oropharyngeal airway through the endoscopic bite and began gastroscopy.Anesthetic maintenance was administered with a continuous pump of 5mg/kg·h propofol until completion of the examination.

Using a new oropharyngeal airway set

The conventional endoscopic biting group (control group) DEVICE

Prior to induction of anesthesia, control study participants inhaled 5 to 6L/min of oxygen through a nasal catheter for approximately 1 minute.Anesthesia was induced by propofol 3mg/kg and sufentanil 7μg.Sufentanil was given at the beginning of pre-oxygen inhalation, and propofol was given 1min later. The endoscopic procedure began when the study participants reached sufficient sedation (about BIS40) and the ordinary endoscopic bite group reached sufficient sedation.Anesthetic maintenance was administered with a continuous pump of 5mg/kg·h propofol until completion of the examination.

The conventional endoscopic bite group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• ≤BMI≤40
• Written informed consent of patient or family
• painless stomach + colonoscopy
• ASA grade I-II

You may not qualify if:

• 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;
• Severe cardiac insufficiency (≤4mets);
• Patients with severe renal insufficiency;
• diagnosed severe hepatic insufficiency;
• Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy;
• Increased intracranial pressure;
• Upper respiratory tract infections such as mouth, nose or throat;
• Fever (core body temperature ≥37.5℃);
• A confirmed diagnosis of pregnancy or breastfeeding;
• Allergic to sedatives such as propofol or equipment such as tape;
• Emergency surgery;
• Multiple trauma;
• SpO2 \< 95% before operation;
• A history of drug and/or alcohol abuse within 2 years prior to the start of the screening period;(Drinking more than three times standard alcoholic beverages per day, equivalent to about 10g of alcohol or equivalent to 50g of Chinese liquor);
• Patients with previous psychiatric and neurological diseases, such as depression, severe central nervous depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis;

Sponsors & Collaborators

• Qianfoshan Hospital: lead

MeSH Terms

Conditions

Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jianbo Wu

  Department director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianbo Wu, Doctorate

CONTACT

18560083793; jianbowu@126.com

Qi You, Master

CONTACT

19553100910; 312011097@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share