HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients
NCT ID: NCT05526339
Last Updated: 2022-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2022-09-30
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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High-flow nasal oxygenation combined with nasopharyngeal airway
High-flow nasal oxygenation combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol.
High-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.
Regular nasal cannula combined with nasopharyngeal airway
Regular nasal cannula combined with nasopharyngeal airway was used in obese patients who are scheduled to undergo gastrointestinal endoscopy procedures sedated with propofol.
Regular 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.
Interventions
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High-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.
Regular 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.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
80 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Soochow University
OTHER
Dushu Lake Hospital Affiliated to Soochow University
OTHER
RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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Diansan Su
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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Dushu Lake Hospital Affiliated to Soochow University
Suzhou, Jiangsu, China
Second Hospital Affiliated to Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Jiang Zhu
Role: primary
Other Identifiers
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LY2022-018-A
Identifier Type: -
Identifier Source: org_study_id
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