HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol

Shanghai Jiao Tong University

Status: Unknown

Conditions: Endometritis; Subseptate Uterus; Endometrial Polyps; Tuberculous Endometritis

Treatments: Device: High Flow Nasal Cannula oxygen (HFNO); Device: Regular oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT05049395

RJ20210904

Details and patient eligibility

About

To determine whether high-flow nasal cannula oxygen can reduce the incidence of hypoxia during the procedure of sedated hysteroscopy.

Enrollment: 960 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 20 years old ≤ age ≤ 50 years old, female.
2. Undergoing hysteroscopy sedated with propofol for diagnosis or treatment.
3. Informed consent
4. BMI≤28kg/m2.
5. ASA physical status Ⅰ~ Ⅱ.

Exclusion criteria

1. Epistaxis, nasal congestion and nasal mucosal damage.
2. Confirmed brain disease (cranial trauma, tumor, stroke, cognitive dysfunction etc.).
3. Confirmed severe heart disease (heart failure, angina pectoris, myocardial infarction, arrhythmia, etc.).
4. Confirmed severe lung diseases (upper respiratory tract infection, asthma, bronchitis, COPD, bullae, pulmonary embolism, pulmonary edema, lung cancer, etc.).
5. Pregnant women.
6. Acute and chronic hepatitis or liver cirrhosis with severe abnormal liver function.
7. Acute and chronic nephritis with severe abnormal renal function or renal failure.
8. Needing oxygen inhalation for underlying diseases.
9. Emergency surgery.
10. Combined with multiple trauma.
11. Allergic to soybean

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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960 participants in 2 patient groups

Control group

Active Comparator group

Description:

The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.

Treatment:

Device: Regular oxygen

HFNO group

Experimental group

Description:

The patients are administered oxygen of 30L-60L/min until the end of the hysteroscopy operation.

Treatment:

Device: High Flow Nasal Cannula oxygen (HFNO)