Hypoxia Clinical Trial
Official title:
Supraglottic Jet Oxygenation and Ventilation (SJOV) for Hypoxemia During Deep Sedation for Gastrointestinal Endoscopy at High-altitude
NCT number | NCT05304923 |
Other study ID # | SJOVGETBHP |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 21, 2022 |
Est. completion date | August 2022 |
This study aims to determine whether the use of SOJV could reduce the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients sedated at high altitude comparing to the supplemental oxygen administration via nasal cannula.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | August 2022 |
Est. primary completion date | August 2022 |
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 |
---|---|---|---|---|
Other | Adverse events related to Supraglottic Jet Oxygenation and Ventilation | pharyngalgia, xerostomia, nasal bleeding, and barotrauma | 20 min after patients are awake | |
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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