Airway Management During Deep Sedation in Hysteroscopy

Deep Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05701839
• Other study ID #: XJTU1AF2022LSK-402
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: October 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Zheng Guan, MD
• Phone: 0086-13572592715
• Email: guanzheng1980[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Sedation

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of low oxygen saturation	oxygen saturation less than 95% last for at least 10 seconds	Procedure (from anesthesia induction to anesthesia recovery)
Secondary	Total duration of assist ventilation	cumulative assist ventilation time during sedation in one patient	Procedure (from anesthesia induction to anesthesia recovery)
Secondary	The lowest oxygen saturation	the lowest oxygen saturation during sedation	Procedure (from anesthesia induction to anesthesia recovery)