EndometritisNCT05049395
HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol
A study testing High Flow Nasal Cannula oxygen (HFNO) and Regular oxygen in people with Endometritis and Tuberculous Endometritis, run by RenJi Hospital at 1 site in China.
Trial summary
To determine whether high-flow nasal cannula oxygen can reduce the incidence of hypoxia during the procedure of sedated hysteroscopy. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Endometritis, Tuberculous Endometritis, Subseptate Uterus
- What is being tested?
- High Flow Nasal Cannula oxygen (HFNO) and Regular oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2021to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Lu Qi, BA contact
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Diansan Su, +862168383702, diansansu@yahoo.com
About this study
Official title: 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.
- Being tested
- High Flow Nasal Cannula oxygen (HFNO), Regular oxygen
- Keywords
- HFNO, Hysteroscopy, Sedation, Hypoxia
- Medical subject headings
- Endometritis, Septate Uterus, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Cannula oxygen (HFNO)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.
Regular oxygenDevice
The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation. Receives: Device: Regular oxygen |
| HFNO group | Experimental | The patients are administered oxygen of 30L-60L/min until the end of the hysteroscopy operation. Receives: Device: High Flow Nasal Cannula oxygen (HFNO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoxia
75%≤SpO2<90% and <60S
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes (1)
The incidence of sub-clinical respiratory depression
90%≤SpO2<95%
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start30 Sep 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometritisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Su Diansan, PhD, Principal investigator, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049395
- Sponsor's protocol ID
- RJ20210904
- Status last verified
- Sep 2021
- First submitted
- 13 Jul 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HFNO Reducing the Incidence of Hypoxia During the Procedure of Hysteroscopy Sedated With Propofol，a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05049395
- Acronym / sponsor ID
- RJ20210904
- Keywords
- HFNO, Hysteroscopy, Sedation, Hypoxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether high-flow nasal cannula oxygen can reduce the incidence of hypoxia during the procedure of sedated hysteroscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Regular oxygenThe patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation. |
| HFNO group | Experimental | Device: High Flow Nasal Cannula oxygen (HFNO)The patients are administered oxygen of 30L-60L/min until the end of the hysteroscopy operation. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | HFNO group |
| Regular oxygenThe patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation. | Device | Control group |
Primary outcome
The incidence of hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
75%≤SpO2<90% and <60S
1 secondary outcome
The incidence of sub-clinical respiratory depression
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Qi, BA contact
Su Diansan, PhD principal investigator
Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula oxygen (HFNO) and Regular oxygen in people with Endometritis and Tuberculous Endometritis, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang Yonglei, BA (86 13641637003, 2367541746@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hypoxia (time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.