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The study investigates the use of high-flow oxygen therapy devices in patients at higher risk of complications during sedated digestive endoscopies. Sedation controlled by the endoscopist improves patient tolerance and facilitates higher-quality procedures, but it can have side effects such as hypoxemia or respiratory depression, especially in patients with sleep apnea, obesity, lung diseases, those over 60 years old, or with a history of sedation complications. While preventive measures, such as oxygen administration, are taken, the study aims to compare the effectiveness of new high-flow oxygen therapy devices with conventional nasal cannulas to improve safety during endoscopies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-flow medical oxygen insufflation | Active Comparator | Low-flow medical oxygen insufflation |
|
| High-flow medical oxygen insufflation | Experimental | High-flow medical oxygen insufflation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flow medical oxygen insufflation | Drug | High-flow medical oxygen insufflation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of episodes of hypoxemia | The number of hypoxemia episodes per procedure | Periprocedural |
| Severity of episode of hypoxemia pO2 value | Severity of episode of hypoxemia (pO2 90- 80%) - (pO2 <80%) | Periprocedural |
| Duration of episode of hypoxemia (in seconds) | Duration of episode of hypoxemia (in seconds) | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| Sex (Demographic and explanatory factors) | Sex (Demographic and explanatory factors) | Periprocedural |
| Age (Demographic and explanatory factors) | Age (Demographic and explanatory factors) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario RÃo Hortega | Valladolid | Valladolid | 47012 | Spain |
Individual participant data will not be shared. The data will be pseudonymized to ensure privacy and will only be accessible to the research team directly involved in the study.
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| Low-flow medical oxygen insufflation | Drug | Low-flow medical oxygen insufflation |
|
| Periprocedural |
| Body mass index (Demographic and explanatory factors) | Body mass index (Demographic and explanatory factors) | Periprocedural |
| Demographic and explanatory factors | anesthetic risk classification: ASA physical status classification Obstructive Sleep Apnea (OSA) or suspected OSA based on the STOP-Bang questionnaire Chronic respiratory disease Chronic heart disease Chronic use of sedative medications History of prior respiratory complication during an endoscopic sedation procedure (ESP) | Periprocedural |
| Medical History Demographic and explanatory factors | Medical History Demographic and explanatory factors | Periprocedural |
| Type of Medication and treatment used (Demographic and explanatory factors) | Type of Medication and treatment used (Demographic and explanatory factors) | Periprocedural |
| Demographic and explanatory factors | Duration of diagnostic/ therapeutic endoscopic Procedure | Periprocedural |
| Variable results | value of baseline pO2 | Periprocedural |
| Variable results | Complications and Clinical Events | Periprocedural |
| Length of stay at recovery room and post-procedure (Variable results) | Length of stay at recovery room and post-procedure | Periprocedural |
| pO2 value (Variable results) | lowest pO2 value during the procedure | Periprocedural |
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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