Airway Management During Deep Sedation in Hysteroscopy

Not Applicable

Not yet recruiting

• Conditions: Deep Sedation
• Interventions: Procedure: face mask ventilation; Procedure: nasopharyngeal tube ventilation; Device: oxygen saturation monitoring; Device: oxygen reserve index monitoring

• Registration Number: NCT05701839
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-12-28
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Last Update Submitted: 2023-01-30
• Study Start: 2023-02-01
• Last Update Posted: 2023-02-01
• Primary Completion: 2023-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
face mask airway management without oxygen reserve index monitoring	face mask ventilation	Participants inhale oxygen through face mask at a flow rate of 5 L/min and will be monitored with oxygen saturation.
nasopharyngeal tube airway management without oxygen reserve index monitoring	oxygen saturation 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.
nasopharyngeal tube airway management with oxygen reserve index monitoring	nasopharyngeal tube ventilation	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.
nasopharyngeal tube airway management with oxygen reserve index monitoring	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.
face mask airway management without oxygen reserve index monitoring	oxygen saturation monitoring	Participants 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	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.
face mask airway management with oxygen reserve index monitoring	face mask ventilation	Participants 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	nasopharyngeal tube ventilation	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China