Hypoxia Clinical Trial
Official title:
Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High Altitudes: High-flow Nasal Oxygen Therapy vs. Supraglottic Jet Oxygenation and Ventilation
This study aims to compare the effect of the use of supraglottic jet oxygenation and ventilation (SJOV) with high-flow nasal oxygen therapy (HFNO) on reducing the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients at high altitudes.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | February 28, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 18 years or older; 2. underwent routine gastrointestinal endoscopy under procedural sedation; 3. consented to participate in this trial. Exclusion Criteria: 1. infection of the upper airway; 2. anatomical abnormalities of the face, nose, and upper airway; 3. coagulopathies; 4. anticipated or known difficult airway; 5. known allergy against propofol, soybeans, and egg; 6. absence from the high-altitude environment during the past 3 months. |
Country | Name | City | State |
---|---|---|---|
China | Tibet autonomous region people's hospital | Lhasa | Tibet |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital | Tibet Autonomous Region People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hypoxia during sedation | An SPO2 of 75 - 89% for < 60 s | During sedation procedure | |
Secondary | respiratory-related complications | pulmonary aspiration, respiratory depression (SPO2 = 90-95%) and severe hypoxia (SPO2 < 75% or < 90% for > 60s) | During sedation procedure | |
Secondary | cardiovascular-related complications | hypotension (systolic blood pressure < 90 mmHg), hypertension (systolic blood pressure > 160 mmHg), bradycardia (heart rate < 50 beats/min), tachycardia (heart rate > 120 beats/min) | During sedation procedure | |
Secondary | fatal complications | severe anaphylactic reactions, myocardial infarction, cardiac arrest and death | from sedation initiation to 20 min after patients are awake |
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