Airway Management During Deep Sedation in Hysteroscopy

May 5, 2026 updated by: Guan Zheng, First Affiliated Hospital Xi'an Jiaotong University

The Effect of Two Different Airway Management on Oxygenation During Deep Sedation in Patients Undergoing Hysteroscopy, Based on Oxygen Reserve Index Monitoring

Hysteroscopy is used to examine and treat uterine diseases. Because of severe pain due to uterine distention and cervical dilatation, deep sedation usually be provided during this procedure. Respiratory depression and upper airway obstruction are main respiratory complications during deep sedation. Face mask and nasopharyngeal airway are main airway management during deep sedation. Oxygen reserve index is a non-invasive parameter, it reflects the moderate hyperoxia statues. In this study, investigators compare the effect of face mask and nasopharyngeal airway management on oxygenation during deep sedation in participants undergoing hysteroscopy. Investigators also investigate whether oxygen reserve index monitoring reduce the incidence of hypoxemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomization:

Participants are divided into four groups: face mask airway management without oxygen reserve index (ORi) monitoring group (FM-ORi group), face mask airway management with ORi monitoring group (FM+ORi group), nasopharyngeal tube airway management without ORi monitoring group (NT-ORi group), nasopharyngeal tube with ORi monitoring group (NT+ORi group).

Deep sedation process:

Participants fasting solid and liquid for 8 and 4 hours respectively. Electrocardiogram (ECG), oxygen saturation (SpO2), blood pressure (BP) and bispectral index (BIS) were monitored. Sufentanil 5 μg injected for 30 seconds, followed by target-control infusion of propofol (plasma target concentration 3-6 ug/ml) to maintain BIS between 50-70. Criteria for deep sedation: participants have purposeful response after repeated and/or painful stimulation, there is minimal effect on hemodynamic stability.

Airway management:

In FM-ORi and FM+ORi group, participants spontaneous inhaled oxygen through face mask at a flow rate of 5 L/min. in FM-ORi group, assist ventilation through face mask was performed when SpO2 dropped to 95%, it lasted for another 10 seconds when SpO2 restored to 100%. In FM+ORi group, assist ventilation through face mask was performed when ORi dropped to 0.1, it lasted for another 10 seconds when ORi restored to 0.1.

In NT-ORi and NT+ORi group, participants spontaneous inhaled oxygen through face mask before induction and through nasopharyngeal tube after consciousness disappear at a flow rate of 5 L/min. in NT-ORi group, assist ventilation through face mask was performed when SpO2 dropped to 95%, it lasted for another 10 seconds when SpO2 restored to 100%. In NT+ORi group, assist ventilation through face mask was performed when ORi dropped to 0.1, it lasted for another 10 seconds when ORI restored to 0.1.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xi'an JiaoTong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female, 18-60 years old
  • Scheduled for hysteroscopy
  • Predict operation duration more than 10 minutes

Exclusion Criteria:

  • Participants refuse
  • Predict the presence of difficult airway
  • Combined with obstructive sleep apnea syndrome
  • Combined with upper respiratory tract infection, and/or pulmonary inflammation
  • Combined with chronic obstructive pulmonary disease
  • Combined with asthma
  • Body mass index (BMI) >30 kg/m2
  • Coagulation dysfunction, and/or undergo anticoagulant therapy
  • Nasal deformity
  • Pregnancy, positive urine pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: face mask airway management without oxygen reserve index monitoring
Participants inhale oxygen through face mask at a flow rate of 5 L/min and will be monitored with oxygen saturation.
Procedure: face mask ventilation
In participants with face mask ventilation, oxygen inhaled through face mask at a flow rate of 5 L/min.
Device: oxygen saturation monitoring
In participants with oxygen saturation monitoring, assist ventilation through face mask will be performed when oxygen saturation drops to 95%, it lasts for another 10 seconds when oxygen saturation restores to 100%.
Experimental: face mask airway management with oxygen reserve index monitoring
Participants inhale oxygen through face mask at a flow rate of 5 L/min and will be monitored with oxygen reserve index.
Procedure: face mask ventilation
In participants with face mask ventilation, oxygen inhaled through face mask at a flow rate of 5 L/min.
Device: oxygen reserve index monitoring
In participants with oxygen reserve index monitoring, assist ventilation through face mask will be performed when oxygen reserve index drops to 0.1, it lasts for another 10 seconds when oxygen reserve index restores to 0.1.
Experimental: nasopharyngeal tube airway management without oxygen reserve index monitoring
Participants inhale oxygen through face mask before induction and through nasopharyngeal tube after consciousness disappear at a flow rate of 5 L/min and will be monitored with oxygen saturation.
Device: oxygen saturation monitoring
In participants with oxygen saturation monitoring, assist ventilation through face mask will be performed when oxygen saturation drops to 95%, it lasts for another 10 seconds when oxygen saturation restores to 100%.
Procedure: nasopharyngeal tube ventilation
In participants with nasopharyngeal tube ventilation, oxygen inhaled through face mask before induction and through nasopharyngeal tube after consciousness disappear at a flow rate of 5 L/min.
Experimental: nasopharyngeal tube airway management with oxygen reserve index monitoring
Participants inhale oxygen through face mask before induction and through nasopharyngeal tube after consciousness disappear at a flow rate of 5 L/min and will be monitored with oxygen reserve index.
Device: oxygen reserve index monitoring
In participants with oxygen reserve index monitoring, assist ventilation through face mask will be performed when oxygen reserve index drops to 0.1, it lasts for another 10 seconds when oxygen reserve index restores to 0.1.
Procedure: nasopharyngeal tube ventilation
In participants with nasopharyngeal tube ventilation, oxygen inhaled through face mask before induction and through nasopharyngeal tube after consciousness disappear at a flow rate of 5 L/min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of low oxygen saturation
Time Frame: Procedure (from anesthesia induction to anesthesia recovery)
oxygen saturation less than 95% last for at least 10 seconds
Procedure (from anesthesia induction to anesthesia recovery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total duration of assist ventilation
Time Frame: Procedure (from anesthesia induction to anesthesia recovery)
cumulative assist ventilation time during sedation in one patient
Procedure (from anesthesia induction to anesthesia recovery)
The lowest oxygen saturation
Time Frame: Procedure (from anesthesia induction to anesthesia recovery)
the lowest oxygen saturation during sedation
Procedure (from anesthesia induction to anesthesia recovery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Chair: Zheng Guan, MD, First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • XJTU1AF2022LSK-402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Investigators have no plan to make individual participant data available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Deep Sedation

Clinical Trials on face mask ventilation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe