HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol

Endometritis Clinical Trial

Official title:

HFNO Reducing the Incidence of Hypoxia During the Procedure of Hysteroscopy Sedated With Propofol，a Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05049395
• Other study ID #: RJ20210904
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: RenJi Hospital
• Contact: Huang Yonglei, BA
• Phone: 86 13641637003
• Email: 2367541746[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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 ?~ ?.

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

Related Conditions & MeSH terms

• Endometrial Polyps
• Endometritis
• Hypoxia

Intervention

Device:
• High Flow Nasal Cannula oxygen (HFNO)
The AIRVO2 is set at 30L/min, FiO2 100%, and 37? before anesthesia induction,and then 60L/min until the end of the procedure of sedated hysteroscopy.
• Regular oxygen
The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of severe hypoxia	SpO2 < 75% or 75% = SpO2 <90% for >= 60 s	Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Other	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 will be followed for the duration of hospital stay, an expected average about 2 hours
Primary	The incidence of hypoxia	75%=SpO2<90% and <60S	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary	The incidence of sub-clinical respiratory depression	90%=SpO2<95%	Patients will be followed for the duration of hospital stay, an expected average about 2 hours