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Clinical Trials in China / NCT07110428
Enrolling by invitation Not applicable

Supraglottic Jet Oxygenation Ventilation During Hysteroscopic Surgery

NCT07110428 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Shenzhen Hospital
Phase
Not applicable
Started
2025-07-03
Last updated
2026-03-03

Condition(s) studied

Hysteroscopic Surgery

Investigational drug(s) / intervention(s)

NCgroupSJOVgroup

NCgroup: The patients in this group received oxygen therapy via nasal cannula at a flow rate of 5 L/min, with an oxygen concentration of 100%. An end-tidal carbon dioxide (ETCO2) monitoring catheter was placed at the nostril opening to monitor ETCO2, observe whether the waveform was regular, and record the values.

SJOVgroup: Gently insert an appropriately sized WNJ tube into one nostril of the subject. Connect one port of the tube to a jet ventilator (Twinstream), with the following SJOV (Synchronized Jet Ventilation) parameters: Driving pressure (DP): 15 psi (1 bar ≈ 15 psi) Respiratory rate: 15 breaths per minute Inspiratory-to-expiratory ratio (I:E): 1:2 Fraction of inspired oxygen (FiO₂): 100% Connect the other port to an end-tidal carbon dioxide (ETCO₂) monitoring catheter to observe the ETCO₂ waveform for regularity and record the numerical values.

Study summary

Hysteroscopic surgery is widely used in the diagnosis and treatment of gynecological diseases. Because its operation process can cause anxiety and pain in patients, it needs to be performed under anesthesia. At present, patients under conventional non-intubation general anesthesia are prone to respiratory depression and hypoxemia. Supraglottic jet oxygen supply and ventilation (SJOV) technology can provide reliable oxygen supply and ventilation for patients with respiratory arrest and respiratory depression. It can assist in completing difficult tracheal intubation, especially in emergency airway situations where "intubation and ventilation cannot be performed". It can effectively avoid catastrophic outcomes and also prevent and reduce hypoxemia in patients undergoing day surgery. However, there are very few studies on hysteroscopic surgery. This study intends to design a single-center randomized controlled study. Patients scheduled for elective hysteroscopic surgery were randomly divided into two groups: the conventional nasal catheter ventilation group and the SJOV group. The feasibility of supraglottic jet oxygenation ventilation in hysteroscopic surgery was studied through different airway management methods. The primary outcome measure was the incidence of intraoperative hypoxemia (75%≤SpO2\<90%, ≤60 seconds), and the secondary outcome measures were subclinical respiratory depression, sore throat and other adverse events. The expected result is that supragttic jet ventilation can improve the incidence of hypoxia in patients during hysteroscopy, reduce sore throat or other complications at the same time, promote patient recovery, and improve patient satisfaction.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
inclusion criteria: * Age between 18 and 65 years, with American Society of Anesthesiologists (ASA) I-II; * Body mass index (BMI) between 18 and 28 kg/m²; * Scheduled for elective hysteroscopic surgery under anesthesia * Signed written informed consent exclusion criteria: * Any upper airway abnormalities that may cause difficult airway management, such as limited mouth opening, Mallampati Class ≥ III, and abnormal neck mobility; history of respiratory insufficiency or sleep apnea, with STOP-BANG score \>3; * Chronic alcohol abuse or drug abuse ; * Current use of anticoagulant medications; * Nasal, oropharyngeal infections or other contraindications for nasopharyngeal airway/WNJ insertion, including active rhinitis, recent nasal surgery, epistaxis, nasal polyps, or nasal stenosis; * Allergy to study medications ; * Intraoperative conversion to endotracheal intubation due to expanded surgical scope or participant's withdrawal of consent.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Shenzhen Hospital Guangdong Shenzhen

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07110428 on ClinicalTrials.gov ↗ ← All trials in China