Application of New Oropharyngeal Airway Management in Patients Undergoing Painless Gastroenteroscopy

NCT06304337 | Recruiting

• 1 other identifier: YXLL-KY-2023(162)
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxia (Spo2<90%,t>10s) and severe hypoxia (Spo2<85%) during anesthetic sedation

  The incidence of hypoxia (75%≤SpO2 \< 90%, \< 60s) and severe hypoxia (SpO2 \< 75% or 75%≤SpO2 \< 90%, ≥60s) during anesthesia was recorded,The time of intervention was half or disappearance of end-expiratory carbon dioxide and/or disappearance of thoracic fluctuation and/or SpO2 \< 95%, that is, open airway manipulation was taken successively until SpO2≥95%, and the last means of opening the airway was recorded.The means of opening the airway of the two groups were the same, including: 1) adjusting the oxygen flow;2) Lift the lower jaw;3) Mask ventilation (pull out the gastroscope if necessary);4) Tracheal intubation or laryngeal mask for ventilator assisted ventilation.

  during surgery

Secondary Outcomes (4)

• The incidence of choking, reflux aspiration and laryngeal spasm were recorded

  during surgery

• The dose of additional drugs during the operation

  during surgery

• Endoscopist satisfaction

  within 30 minutes after surgery

• Record adverse events that occur throughout the process

  during surgery

Study Arms (2)

Ordinary oral cushion set

NO INTERVENTION

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.

New oropharyngeal airway group

EXPERIMENTAL

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

Device: New oropharyngeal airway group

Interventions

New oropharyngeal airway group 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.

New oropharyngeal airway group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 (requiring dialysis before surgery);
• Diagnosed severe liver 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 degrees Celsius);
• a confirmed diagnosis of pregnancy or breastfeeding;
• Allergic to sedatives such as propofol or equipment such as tape;
• Emergency surgery;
• Multiple trauma;
• SpO2 \< 95% in preoperative breathing air;

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

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

Jinan, China

RECRUITING

Study Officials

• Jianbo Wu

  Department director

  STUDY DIRECTOR

Central Study Contacts

Jianbo Wu

CONTACT

jianbowu@126.com; 312011097@qq.com

qi You

CONTACT

312011097@qq.com; jianbowu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion: October 10, 2024
• Study Completion: March 3, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)