Supraglottic Jet Oxygenation Ventilation During Hysteroscopic Surgery

Supraglottic Jet Oxygenation Ventilation During Hysteroscopic Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hysteroscopic Surgery
• Intervention / Treatment: Procedure: NCgroup; Procedure: SJOVgroup

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shenzhen
    • Guangdong, Shenzhen, China, 518000
      • Peking University Shenzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NC group; Received the medication regimen: propofol at 1.5-3.0 mg/kg for sedation and fentanyl at 1.5mcg/kg for analgesia. During the maintenance phase, propofol was administered via infusion at a dose of 5 mg/kg/h . The level of sedation was maintained at 0 ≤ MOAA/S score ≤ 1. When the MOAA/S score of the subjects reached 0 after induction, nasal cannula was administered according to the group assignment. Intraoperative vital signs were closely monitored, and data on surgery duration, anesthetic dosage, blood oxygen saturation, recovery time, and possible adverse events (significant increases or decreases in blood pressure and heart rate, nausea and vomiting, decreased blood oxygen saturation, and jaw lift) were recorded. After surgery, patients were transferred to the post-anesthesia care unit (PACU) and were allowed to return to the ward once their modified Aldrete Score reached 9.	Procedure: 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.
Experimental: SJOV group; Received the medication regimen: propofol at 1.5-3.0 mg/kg for sedation and fentanyl at 1.5mcg/kg for analgesia. During the maintenance phase, propofol was administered via infusion at a dose of 5 mg/kg/h . The level of sedation was maintained at 0 ≤ MOAA/S score ≤ 1. When the MOAA/S score of the subjects reached 0 after induction, SJOV was administered according to the group assignment. Intraoperative vital signs were closely monitored, and data on surgery duration, anesthetic dosage, blood oxygen saturation, recovery time, and possible adverse events (significant increases or decreases in blood pressure and heart rate, nausea and vomiting, decreased blood oxygen saturation, and jaw lift) were recorded. After surgery, patients were transferred to the post-anesthesia care unit (PACU) and were allowed to return to the ward once their modified Aldrete Score reached 9.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypoxemia	75%<=SPO2<90%	Perioperative

Collaborators and Investigators

• Sponsor: Peking University Shenzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2025
• Primary Completion (Estimated): March 20, 2026
• Study Completion (Estimated): March 20, 2026

Study Registration Dates

• First Submitted: June 25, 2025
• First Submitted That Met QC Criteria: July 30, 2025
• First Posted (Actual): August 7, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: SJOV; Anesthetic ventilation methods
• Other Study ID Numbers: 2025-115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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