NCT05049395UnknownNot Applicable
HFNO Reducing the Incidence of Hypoxia During the Procedure of Hysteroscopy Sedated With Propofol，a Randomized, Controlled Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- RenJi Hospital
- Enrollment
- 960
- Locations
- 1
- Primary Endpoint
- The incidence of hypoxia
Study Overview
Brief Summary
To determine whether high-flow nasal cannula oxygen can reduce the incidence of hypoxia during the procedure of sedated hysteroscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •20 years old ≤ age ≤ 50 years old, female.
- •Undergoing hysteroscopy sedated with propofol for diagnosis or treatment.
- •Informed consent
- •ASA physical status Ⅰ~ Ⅱ.
Exclusion Criteria
- •Epistaxis, nasal congestion and nasal mucosal damage.
- •Confirmed brain disease (cranial trauma, tumor, stroke, cognitive dysfunction etc.).
- •Confirmed severe heart disease (heart failure, angina pectoris, myocardial infarction, arrhythmia, etc.).
- •Confirmed severe lung diseases (upper respiratory tract infection, asthma, bronchitis, COPD, bullae, pulmonary embolism, pulmonary edema, lung cancer, etc.).
- •Pregnant women.
- •Acute and chronic hepatitis or liver cirrhosis with severe abnormal liver function.
- •Acute and chronic nephritis with severe abnormal renal function or renal failure.
- •Needing oxygen inhalation for underlying diseases.
- •Emergency surgery.
- •Combined with multiple trauma.
- •Allergic to soybean
Arms & Interventions
Control group
Active Comparator
The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.
Intervention: Regular oxygen (Device)
HFNO group
Experimental
The patients are administered oxygen of 30L-60L/min until the end of the hysteroscopy operation.
Intervention: High Flow Nasal Cannula oxygen (HFNO) (Device)
Outcomes
Primary Outcomes
The incidence of hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
75%≤SpO2\<90% and \<60S
Secondary Outcomes
- The incidence of sub-clinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
Investigators
Study Sites (1)
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