Hypoxia, High Altitude
Conditions
Brief summary
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.
Detailed description
The participants will be randomly allocated to either SJOV or nasal cannula oxygen supply in a 1:1 ratio using block randomization with variable block sizes of four or six randomized. In the nasal cannula oxygen supply group, oxygen supplementation at 2 liters min-1 is delivered via a nasal cannula. In the SJOV group, SJOV is conducted using a Wei nasal jet tube (WNJ, Well Lead Medical Co. Ltd, Guangzhou, China) which is connected to a manual jet ventilator (Well Lead Medical Co. Ltd, Guangzhou, China) via its jet port.
Interventions
Supraglottic jet oxygenation and ventilation is conducted using a Wei nasal jet tube (WNJ, Well Lead Medical Co. Ltd, Guangzhou, China) which is connected to a manual jet ventilator (Well Lead Medical Co. Ltd, Guangzhou, China) via its jet port. The initial settings of SJOV are: driving pressure (DP) 15psi, respiratory rate (RR) 20 bpm, inspiratory-to-expiratory (I/E) ratio 1:2, and gas supply 100% oxygen.
PROCEDURENasal cannula oxygen supply
Oxygen supplementation at 2 liters min-1 is delivered via a nasal cannula
Sponsors
Tibet Autonomous Region People's Hospital
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxia during sedation | During sedation procedure | An SPO2 of 75 - 89% for \< 60 s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| respiratory-related complications | During sedation procedure | pulmonary aspiration, respiratory depression (SPO2 = 90-95%) and severe hypoxia (SPO2 \< 75% or \< 90% for \> 60s) |
| cardiovascular-related complications | During sedation procedure | hypotension (systolic blood pressure \< 90 mmHg), hypertension (systolic blood pressure \> 160 mmHg), bradycardia (heart rate \< 50 beats/min), tachycardia (heart rate \> 120 beats/min) |
| fatal complications | from sedation initiation to 20 min after patients are awake | severe anaphylactic reactions, myocardial infarction, cardiac arrest and death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events related to Supraglottic Jet Oxygenation and Ventilation | 20 min after patients are awake | pharyngalgia, xerostomia, nasal bleeding, and barotrauma |
Countries
China
Contacts
Primary ContactBailin Jiang
Backup ContactLaba Ciren
Outcome results
None listed