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| Name | Class |
|---|---|
| Tibet Autonomous Region People's Hospital | OTHER |
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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.
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.
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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. |
|
| nasal cannula oxygen supply | Placebo Comparator | Oxygen supplementation is delivered via a nasal cannula to the participants during sedation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supraglottic jet oxygenation and ventilation | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events related to Supraglottic Jet Oxygenation and Ventilation | pharyngalgia, xerostomia, nasal bleeding, and barotrauma | 20 min after patients are awake |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bailin Jiang | Contact | 86-13810986114 | jiangbailin@bjmu.edu.cn | |
| Laba Ciren | 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36376852 | Derived | Jiang B, Li Y, Ciren D, Dawa O, Feng Y, Laba C. Supraglottic jet oxygenation and ventilation decreased hypoxemia during gastrointestinal endoscopy under deep sedation at high altitudes: a randomized clinical trial. BMC Anesthesiol. 2022 Nov 14;22(1):348. doi: 10.1186/s12871-022-01902-3. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 4, 2022 | |
| Reset | May 16, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 4, 2022 | May 16, 2023 |
| 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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| ID | Term |
|---|---|
| D014691 | Ventilation |
| ID | Term |
|---|---|
| D004780 | Environment, Controlled |
| D004777 | Environment |
| D004778 | Environment and Public Health |
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|
| Nasal cannula oxygen supply | Procedure | Oxygen supplementation at 2 liters min-1 is delivered via a nasal cannula |
|
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 |