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

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

Study Overview

• Status: Recruiting
• Conditions: Endometritis; Endometrial Polyps; Tuberculous Endometritis; Subseptate Uterus
• Intervention / Treatment: Device: Regular oxygen; Device: High Flow Nasal Cannula oxygen (HFNO)

• Study Type: Interventional
• Enrollment (Anticipated): 960
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huang Yonglei, BA; Phone Number: 86 13641637003; Email: 2367541746@qq.com
• Study Contact Backup: Name: Lu Qi, BA; Phone Number: 86 21 68383364

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • RenJi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.	Device: Regular oxygen; The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.
Experimental: HFNO group; The patients are administered oxygen of 30L-60L/min until the end of the hysteroscopy operation.	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Su Diansan, PhD, Department of Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Hypoxia; Sedation; Hysteroscopy; HFNO
• Additional Relevant MeSH Terms: Uterine Diseases; Adnexal Diseases; Signs and Symptoms, Respiratory; Pelvic Inflammatory Disease; Hypoxia; Endometritis
• Other Study ID Numbers: RJ20210904

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No