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| Name | Class |
|---|---|
| Tibet Autonomous Region People's Hospital | OTHER |
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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.
The participants will be randomly allocated to either SJOV or HFNO in a 1:1 ratio using block randomization with variable block sizes of four or six randomized. In the HFNO group, oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%. 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. The initial settings of SJOV were as follows: driving pressure (DP) 15 psi; respiratory rate (RR) 20 bpm; inspiratory-to-expiratory (I/E) ratio 1:2, and gas supply, 100% oxygen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supraglottic jet oxygenation and ventilation | Experimental | Supraglottic jet oxygenation and ventilation is conducted for the participants during sedation. |
|
| High-flow nasal oxygen therapy | Active Comparator | High-flow nasal oxygen therapy is conducted for the participants during sedation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SJOV | Procedure | 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. The initial settings of SJOV were as follows: driving pressure (DP) 15 psi; respiratory rate (RR) 20 bpm; inspiratory-to-expiratory (I/E) ratio 1:2, and gas supply, 100% oxygen. |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxia during sedation | An SPO2 of 75 - 89% for < 60 s | During sedation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| respiratory-related complications | pulmonary aspiration, respiratory depression (SPO2 = 90-95%) and severe hypoxia (SPO2 < 75% or < 90% for > 60s) | During sedation procedure |
| cardiovascular-related complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bailin Jiang | Contact | 86-13810986114 | jiangbailin@bjmu.edu.cn | |
| Ciren Laba | Contact | 86-13989098788 | lbcr010203@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Feng | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tibet autonomous region people's hospital | Recruiting | Lhasa | Tibet | China |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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| HFNO | Procedure | HFNO is conducted. Oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%. |
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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 |
| fatal complications | severe anaphylactic reactions, myocardial infarction, cardiac arrest and death | from sedation initiation to 20 min after patients are awake |
| D012140 | Respiratory Tract Diseases |