HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol

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

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

Conditions
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Endometritis, Tuberculous Endometritis, Subseptate Uterus, Endometrial Polyps

Intervention / Treatment
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* Device: High Flow Nasal Cannula oxygen (HFNO)
* Device: Regular oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 years old ≤ age ≤ 50 years old, female. Undergoing hysteroscopy sedated with propofol for diagnosis or treatment. Informed consent BMI≤28kg/m2. 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation. | Device: Regular oxygen<br>* The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.<br>|
| Experimental: HFNO group<br>The patients are administered oxygen of 30L-60L/min until the end of the hysteroscopy operation. | Device: High Flow Nasal Cannula oxygen (HFNO)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HFNO, Hysteroscopy, Sedation, Hypoxia