Deep SedationNCT05701839
Airway Management During Deep Sedation in Hysteroscopy
A study testing face mask ventilation, nasopharyngeal tube ventilation and oxygen saturation monitoring in people with Deep Sedation, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Deep Sedation
- What is being tested?
- face mask ventilation, nasopharyngeal tube ventilation and oxygen saturation monitoring
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, 18-60 years old
- Scheduled for hysteroscopy
- Predict operation duration more than 10 minutes
Who cannot join
- 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
Show all 10Show fewer
- Body mass index (BMI) >30 kg/m2
- Coagulation dysfunction, and/or undergo anticoagulant therapy
- Nasal deformity
- Pregnancy, positive urine pregnancy test
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: 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.
Read the 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.
- Conditions
- Deep Sedation
- Being tested
- face mask ventilation, nasopharyngeal tube ventilation, oxygen saturation monitoring, oxygen reserve index monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
face mask ventilationProcedure or surgery
In participants with face mask ventilation, oxygen inhaled through face mask at a flow rate of 5 L/min.
nasopharyngeal tube ventilationProcedure or surgery
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.
oxygen saturation monitoringDevice
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%.
oxygen reserve index monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| face mask airway management without oxygen reserve index monitoring | Experimental | Participants inhale oxygen through face mask at a flow rate of 5 L/min and will be monitored with oxygen saturation. Receives: Procedure: face mask ventilation; Device: oxygen saturation monitoring |
| face mask airway management with oxygen reserve index monitoring | Experimental | Participants inhale oxygen through face mask at a flow rate of 5 L/min and will be monitored with oxygen reserve index. Receives: Procedure: face mask ventilation; Device: oxygen reserve index monitoring |
| nasopharyngeal tube airway management without oxygen reserve index monitoring | Experimental | 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. Receives: Procedure: nasopharyngeal tube ventilation; Device: oxygen saturation monitoring |
| nasopharyngeal tube airway management with oxygen reserve index monitoring | Experimental | 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. Receives: Procedure: nasopharyngeal tube ventilation; Device: oxygen reserve index monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of low oxygen saturation
oxygen saturation less than 95% last for at least 10 seconds
Measured: Procedure (from anesthesia induction to anesthesia recovery)
Secondary outcomes (2)
Total duration of assist ventilation
cumulative assist ventilation time during sedation in one patient
Measured: Procedure (from anesthesia induction to anesthesia recovery)
The lowest oxygen saturation
the lowest oxygen saturation during sedation
Measured: Procedure (from anesthesia induction to anesthesia recovery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Feb 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep SedationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guan Zheng, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Zheng Guan, MD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701839
- Sponsor's protocol ID
- XJTU1AF2022LSK-402
- Status last verified
- Sep 2024
- First submitted
- 28 Dec 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators have no plan to make individual participant data available to other researchers
Publications
Guan Z, Li X, Liu L, Liu J, Gao Y. Oxygen reserve index monitoring reduced the incidence of low pulse oxygen saturation during deep sedation for hysteroscopy: a prospective randomized controlled trial. Front Med (Lausanne). 2026 Feb 18;13:1732543. doi: 10.3389/fmed.2026.1732543. eCollection 2026.
PubMed 41788712
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Airway Management on Oxygenation During Deep Sedation in Patients Undergoing Hysteroscopy, Based on Oxygen Reserve Index Monitoring
- ClinicalTrials.gov ID
- NCT05701839
- Acronym / sponsor ID
- XJTU1AF2022LSK-402
- Conditions
- Deep Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| face mask airway management without oxygen reserve index monitoring | Experimental | Procedure: face mask ventilation, Device: oxygen saturation monitoringParticipants inhale oxygen through face mask at a flow rate of 5 L/min and will be monitored with oxygen saturation. |
| face mask airway management with oxygen reserve index monitoring | Experimental | Procedure: face mask ventilation, Device: oxygen reserve index monitoringParticipants inhale oxygen through face mask at a flow rate of 5 L/min and will be monitored with oxygen reserve index. |
| nasopharyngeal tube airway management without oxygen reserve index monitoring | Experimental | Procedure: nasopharyngeal tube ventilation, Device: oxygen saturation monitoringParticipants 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. |
| nasopharyngeal tube airway management with oxygen reserve index monitoring | Experimental | Procedure: nasopharyngeal tube ventilation, Device: oxygen reserve index monitoringParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female, 18-60 years old
- Scheduled for hysteroscopy
- Predict operation duration more than 10 minutes
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| face mask ventilationIn participants with face mask ventilation, oxygen inhaled through face mask at a flow rate of 5 L/min. | Procedure or surgery | face mask airway management with oxygen reserve index monitoring, face mask airway management without oxygen reserve index monitoring |
| nasopharyngeal tube ventilationIn 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. | Procedure or surgery | nasopharyngeal tube airway management with oxygen reserve index monitoring, nasopharyngeal tube airway management without oxygen reserve index monitoring |
| oxygen saturation monitoringIn 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%. | Device | face mask airway management without oxygen reserve index monitoring, nasopharyngeal tube airway management without oxygen reserve index monitoring |
| oxygen reserve index monitoringIn 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. | Device | face mask airway management with oxygen reserve index monitoring, nasopharyngeal tube airway management with oxygen reserve index monitoring |
Primary outcome
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
2 secondary outcomes
Total duration of assist ventilation
Time frame: Procedure (from anesthesia induction to anesthesia recovery)
The lowest oxygen saturation
Time frame: Procedure (from anesthesia induction to anesthesia recovery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 41788712Guan Z, Li X, Liu L, Liu J, Gao Y. Oxygen reserve index monitoring reduced the incidence of low pulse oxygen saturation during deep sedation for hysteroscopy: a prospective randomized controlled trial. Front Med (Lausanne). 2026 Feb 18;13:1732543. doi: 10.3389/fmed.2026.1732543. eCollection 2026.
- Individual participant dataSharing planned: No. Investigators have no plan to make individual participant data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zheng Guan, MD study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing face mask ventilation, nasopharyngeal tube ventilation and oxygen saturation monitoring in people with Deep Sedation, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of low oxygen saturation (time frame: Procedure (from anesthesia induction to anesthesia recovery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05701839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.