Airway Management During Deep Sedation in Hysteroscopy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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. |
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.
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: 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. |
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.
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.
|
Outcome Measures
Primary Outcome Measures
- The incidence of low oxygen saturation [Procedure (from anesthesia induction to anesthesia recovery)]
oxygen saturation less than 95% last for at least 10 seconds
Secondary Outcome Measures
- Total duration of assist ventilation [Procedure (from anesthesia induction to anesthesia recovery)]
cumulative assist ventilation time during sedation in one patient
- The lowest oxygen saturation [Procedure (from anesthesia induction to anesthesia recovery)]
the lowest oxygen saturation during sedation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female, 18-60 years old
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Scheduled for hysteroscopy
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Predict operation duration more than 10 minutes
Exclusion Criteria:
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Participants refuse
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Predict the presence of difficult airway
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Combined with obstructive sleep apnea syndrome
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Combined with upper respiratory tract infection, and/or pulmonary inflammation
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Combined with chronic obstructive pulmonary disease
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Combined with asthma
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Body mass index (BMI) >30 kg/m2
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Coagulation dysfunction, and/or undergo anticoagulant therapy
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Nasal deformity
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Pregnancy, positive urine pregnancy test
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | China | 710061 |
Sponsors and Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
Investigators
- Study Chair: Zheng Guan, MD, First Affiliated Hospital Xi'an Jiaotong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XJTU1AF2022LSK-402