WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

Shanghai Jiao Tong University

Status: Unknown

Conditions: Esophagus Cancer; Peptic Ulcer; Gastric Cancer; Hypoxia; Oesophagitis

Treatments: Device: WEI NASAL JET; Device: Nasopharyngeal airway without jet ventilator

Study type: Interventional

Funder types: Other

Identifiers

NCT02436018

RenJiH-20150308

Details and patient eligibility

About

Low pulse oximetry is the most common adverse events during sedation for upper gastrointestinal endoscopy. The main reason is the glossoptosis after sedation. In present study a new designed nasopharyngeal airway embedded with jet ventilation catheter(WEI NASAL JET) will be utilized in order to reduce the hypoxia. At the same time the safety will be evaluated.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing upper gastrointestinal endoscopy
• age over 18 years old
• Signed informed consent form

Exclusion criteria

• a blood coagulation dysfunction or have a tendency of nose bleeding
• a clear diagnosis of heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
• a clear diagnosis of lung disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, lung cancer)
• pregnant
• liver disease
• kidney disease
• increase in intracranial pressure
• emergency operation
• multiple trauma
• American Society of Anesthesiologists (ASA) Physical Status classification above IV
• with mouth, nose and throat infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,800 participants in 3 patient groups

Control group

No Intervention group

Description:

Oxygen(2L/min) supplied with nasal catheter

Nasopharyngeal airway group

Experimental group

Description:

Oxygen(2L/min) supplied directly through WEI NASAL JET without jet ventilator

Treatment:

Device: Nasopharyngeal airway without jet ventilator

WEI NASAL JET group

Experimental group

Description:

Oxygen supplied through WEI NASAL JET with a manual jet ventilator

Treatment:

Device: WEI NASAL JET