NCT05049395

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
960

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

July 13, 2021

Last Update Submit

September 29, 2021

Conditions

EndometritisTuberculous EndometritisSubseptate UterusEndometrial Polyps

Keywords

HFNOHysteroscopySedationHypoxia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The incidence of sub-clinical respiratory depression

    Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Other Outcomes (2)

  • The incidence of severe hypoxia

    Patients will be followed for the duration of hospital stay, an expected average about 2 hours

  • The incidence of other adverse events

    Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Device: Regular oxygen

HFNO group

EXPERIMENTAL

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

Device: High Flow Nasal Cannula oxygen (HFNO)

Interventions

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.

HFNO group
Regular oxygenDEVICE

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

Control group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

EndometritisSeptate UterusHypoxia

Condition Hierarchy (Ancestors)

Pelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine DiseasesGenital DiseasesUterine Duplication AnomaliesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Su Diansan, PhD

    Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huang Yonglei, BA

CONTACT

86 136416370032367541746@qq.com

Lu Qi, BA

CONTACT

86 21 68383364

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2021

First Posted

September 20, 2021

Study Start

September 30, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

October 1, 2021

Record last verified: 2021-09

Locations

CN(1)