Gastric Cancer, Gastric Ulcer, Intestinal Cancer, Intestinal Polyps
Conditions
Keywords
High-flow nasal oxygenation, Gastrointestinal endoscopy, Hypoxia
Brief summary
Obesity is associated with adverse airway events including desaturation during deep sedation. Previous studies have suggested that high-flow nasal oxygenation may be superior to regular (low-flow) nasal cannula for prevention of hypoxia during Sedated Gastrointestinal Endoscopy in non-obesity patients. The prerequisite of high-flow nasal oxygenation is keeping airway patency. Our pervious study demonstrated that nasopharyngeal airway has the similar efficacy of jaw-lift. In present study we aimed to determine whether high-flow nasal oxygenation combined with nasopharyngeal airway could reduce the incidence of hypoxia during Sedated Gastrointestinal Endoscopy in obese patients.
Interventions
DEVICEHigh-flow nasal oxygenation combined with nasopharyngeal airway
The patients receive an oxygen flow of 30 L/min for preoxygenation with a high-flow oxygenation device before losing of conscious. At the time of the abolition of the eyelash reflex, the gas flow was increased to 60 L/min with an inspired oxygen fraction 100% and the nasopharyngeal airway was placed.
DEVICERegular nasal cannula combined with nasopharyngeal airway
The patients receive an oxygen flow of 6 L/min for preoxygenation with a regular nasal cannula until the end of procedure. At the time of abolition of the eyelash reflex, the nasopharyngeal airway was placed.
Sponsors
Second Affiliated Hospital of Soochow University
Dushu Lake Hospital Affiliated to Soochow University
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients receiving selective combined upper intestinal and lower intestinal endoscopy procedure under deep sedation. 2. Age ranging from 19 to 80, both male and female 3. Obese patients，BMI ≥ 28kg/m\^2 4. ASA I\ III 5. Patients should clearly understand and voluntarily participate in the study, with signed informed consent.
Exclusion criteria
1. Patients with acute respiratory infection in the last 2 weeks 2. Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery 3. hypoxia, defined as oxygen saturation measured by pulse oximetry (SpO2) ≤ 95% before preoxygenation. 4. Common advanced gastrointestinal endoscopy procedures meeting eligibility criteria included cholangiopancreatography, endoscopic ultrasound procedures, endoscopic mucosal resection and endoscopic retrograde cholangiopancreatography (ERCP) procedures. 5. coagulation disorders or platelets \< 100\*10\^9/L 6. Have serious heart diseases such as severe arrhythmia, heart failure, Adams Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance \< 4mets 7. Allergy to eggs, soy products, opioids and other drugs, propofol, etc. 8. Participated in other clinical trials as a subject within 3 months 9. Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc. 10. Emergency procedure 11. Pregnant or breast-feeding women 12. Patients having procedures with planned tracheal intubation or laryngeal mask 13. Investigator considers the patients are inappropriate to participate in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of hypoxia | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | Hypoxia refers to 75%≤SpO2\<90%,\<60S |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of severe hypoxia | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | Severe hypoxia refers to SpO2\<75% lasting for any time, or 75%≤SpO2\<90%, ≥60s |
| The incidence of subclinical respiratory depression | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | Subclinical respiratory depression refers to 90%≤ SpO2\<95% |
| The incidence of other adverse events | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force |
Countries
China
Contacts
Primary ContactDiansan Su
Backup ContactLingke Chen
Outcome results
None listed