Back to resultsHFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol
Primary Purpose
Endometritis, Tuberculous Endometritis, Subseptate Uterus
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High Flow Nasal Cannula oxygen (HFNO)
Regular oxygen
Sponsored by
About this trial
This is an interventional prevention trial for Endometritis focused on measuring HFNO, Hysteroscopy, Sedation, Hypoxia
Eligibility Criteria
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
Sites / Locations
- Renji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
HFNO group
Arm Description
The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.
The patients are administered oxygen of 30L-60L/min until the end of the hysteroscopy operation.
Outcomes
Primary Outcome Measures
The incidence of hypoxia
75%≤SpO2<90% and <60S
Secondary Outcome Measures
The incidence of sub-clinical respiratory depression
90%≤SpO2<95%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05049395
Brief Title
HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol
Official Title
HFNO Reducing the Incidence of Hypoxia During the Procedure of Hysteroscopy Sedated With Propofol，a Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine whether high-flow nasal cannula oxygen can reduce the incidence of hypoxia during the procedure of sedated hysteroscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometritis, Tuberculous Endometritis, Subseptate Uterus, Endometrial Polyps
Keywords
HFNO, Hysteroscopy, Sedation, Hypoxia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
960 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.
Arm Title
HFNO group
Arm Type
Experimental
Arm Description
The patients are administered oxygen of 30L-60L/min until the end of the hysteroscopy operation.
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Cannula oxygen (HFNO)
Intervention Description
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
Intervention Name(s)
Regular oxygen
Intervention Description
The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.
Primary Outcome Measure Information:
Title
The incidence of hypoxia
Description
75%≤SpO2<90% and <60S
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary Outcome Measure Information:
Title
The incidence of sub-clinical respiratory depression
Description
90%≤SpO2<95%
Time Frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Other Pre-specified Outcome Measures:
Title
The incidence of severe hypoxia
Description
SpO2 < 75% or 75% ≤ SpO2 <90% for >= 60 s
Time Frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Title
The incidence of other adverse events
Description
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Time Frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huang Yonglei, BA
Phone
86 13641637003
Email
2367541746@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Qi, BA
Phone
86 21 68383364
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su Diansan, PhD
Organizational Affiliation
Department of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diansan Su
Phone
+862168383702
Email
diansansu@yahoo.com
12. IPD Sharing Statement
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HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol
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