HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol

Not Applicable

• Conditions: Tuberculous Endometritis; Subseptate Uterus; Endometritis; Endometrial Polyps
• Interventions: Device: Regular oxygen; Device: High Flow Nasal Cannula oxygen (HFNO)

• Registration Number: NCT05049395
• Lead Sponsor: RenJi Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-13
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-20
• Last Update Submitted: 2021-09-29
• Study Start: 2021-09-30
• Last Update Posted: 2021-10-01
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 960

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Regular oxygen	The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.
HFNO group	High Flow Nasal Cannula oxygen (HFNO)	The patients are administered oxygen of 30L-60L/min until the end of the hysteroscopy operation.

Primary Outcome Measures

Name	Time	Method
The incidence of hypoxia	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	75%≤SpO2\<90% and \<60S

Secondary Outcome Measures

Name	Time	Method
The incidence of sub-clinical respiratory depression	Patients will be followed for the duration of hospital stay, an expected average about 2 hours	90%≤SpO2\<95%

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China