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Airway Management During Deep Sedation in Hysteroscopy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05701839
Enrollment
400
Registered
2023-01-27
Start date
2023-02-01
Completion date
2024-11-30
Last updated
2023-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Sedation

Brief 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. 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.

Interventions

In participants with face mask ventilation, oxygen inhaled through face mask at a flow rate of 5 L/min.

PROCEDUREnasopharyngeal 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.

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%.

DEVICEoxygen 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.

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of low oxygen saturationProcedure (from anesthesia induction to anesthesia recovery)oxygen saturation less than 95% last for at least 10 seconds

Secondary

MeasureTime frameDescription
The lowest oxygen saturationProcedure (from anesthesia induction to anesthesia recovery)the lowest oxygen saturation during sedation
Total duration of assist ventilationProcedure (from anesthesia induction to anesthesia recovery)cumulative assist ventilation time during sedation in one patient

Countries

China

Contacts

Primary ContactZheng Guan, MD
guanzheng1980@126.com0086-13572592715

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026