Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing gastrointestinal endoscopy 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 gastrointestinal endoscopy under propofol sedation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,200
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
Using regular nasal cannula for oxygenation.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGThe First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGShangdong Provincial Qianfoshan Hospital
Jinan, Shandong, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGRenji Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGTongji Hospital Of Tongji University
Shanghai, Shanghai Municipality, China
RECRUITINGXinhua Hospital Affliated To Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghia, China
RECRUITINGThe First Affliated Hospital of Xi'an Jiangtong University
Xi’an, Shanxi, China
RECRUITINGTianjin Mediacal University General Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGThe First Affliated Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
RECRUITINGThe incidence of hypoxia
(75% ≤ SpO2 \< 90% for \<60 s)
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of sub-clinical respiratory depression
(90% ≤ SpO2 \< 95%)
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxia
(SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s)
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
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