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HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05049395
Enrollment
960
Registered
2021-09-20
Start date
2021-09-30
Completion date
2022-09-30
Last updated
2021-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Polyps, Endometritis, Subseptate Uterus, Tuberculous Endometritis

Keywords

HFNO, Hysteroscopy, Sedation, Hypoxia

Brief summary

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

Interventions

DEVICEHigh 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.

DEVICERegular oxygen

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

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of hypoxiaPatients will be followed for the duration of hospital stay, an expected average of 2 hours75%≤SpO2\<90% and \<60S

Secondary

MeasureTime frameDescription
The incidence of sub-clinical respiratory depressionPatients will be followed for the duration of hospital stay, an expected average about 2 hours90%≤SpO2\<95%

Other

MeasureTime frameDescription
The incidence of severe hypoxiaPatients will be followed for the duration of hospital stay, an expected average about 2 hoursSpO2 \< 75% or 75% ≤ SpO2 \<90% for \>= 60 s
The incidence of other adverse eventsPatients will be followed for the duration of hospital stay, an expected average about 2 hoursOther adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force

Countries

China

Contacts

Primary ContactHuang Yonglei, BA
2367541746@qq.com86 13641637003
Backup ContactLu Qi, BA
86 21 68383364

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026