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Clinical Trials/NCT05049395
NCT05049395
Unknown
Not Applicable

HFNO Reducing the Incidence of Hypoxia During the Procedure of Hysteroscopy Sedated With Propofol,a Randomized, Controlled Trial

RenJi Hospital1 site in 1 country960 target enrollmentSeptember 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometritis
Sponsor
RenJi Hospital
Enrollment
960
Locations
1
Primary Endpoint
The incidence of hypoxia
Last Updated
4 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
September 30, 2021
End Date
September 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 20 years old ≤ age ≤ 50 years old, female.
  • Undergoing hysteroscopy sedated with propofol for diagnosis or treatment.
  • Informed consent
  • 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • The incidence of sub-clinical respiratory depression(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)

Study Sites (1)

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