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Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing fiberoptic bronchoscopy with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of our randomized study is to assess the efficacy and safety of the COMBO Endoscopy Oropharyngeal Airway reduce the incidence of hypoxia on patients undergoing fiberoptic bronchoscopy under propofol sedation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the COMBO Endoscopy Oropharyngeal Airway Group | Other | In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the COMBO Endoscopy Oropharyngeal Airway | Device | Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of hypoxia(75% ≤ SpO2 < 90% for <60 s) | Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit). |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of sub-clinical respiratory depression(90% ≤ SpO2 < 95%) | Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit). | |
| The incidence of severe hypoxia(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s) |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of other adverse events | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force | Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affliated Hospital, Zhejiang University School Of Medicine | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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The COMBO Endoscopy Oropharyngeal Airway integrates a bite block, capnography monitoring, oxygenation support, and an innovative oropharyngeal airway design. The COMBO device is a novel airway management device with integrated capnography monitoring and dual oxygenation support. It was developed to overcome persistent challenges in maintaining airway patency and oxygenation during bronchoscopy under sedation.
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| Patients are continuously monitored from the beginning of anesthesia induction until exiting the PACU (Post-Anesthesia Care Unit). |
| D013568 | Pathological Conditions, Signs and Symptoms |