HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol

NCT ID: NCT05049395

Last Updated: 2021-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-09-30

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.

Detailed Description

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Conditions

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Endometritis Tuberculous Endometritis Subseptate Uterus Endometrial Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Regular oxygen

Intervention Type DEVICE

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

HFNO group

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

Group Type EXPERIMENTAL

High Flow Nasal Cannula oxygen (HFNO)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Regular oxygen

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Su Diansan, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huang Yonglei, BA

Role: CONTACT

86 13641637003

Lu Qi, BA

Role: CONTACT

86 21 68383364

Facility Contacts

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Diansan Su

Role: primary

+862168383702

Other Identifiers

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RJ20210904

Identifier Type: -

Identifier Source: org_study_id

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