Airway Management During Deep Sedation in Hysteroscopy

NCT05701839 | Unknown

• 1 other identifier: XJTU1AF2022LSK-402
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total duration of assist ventilation

  Procedure (from anesthesia induction to anesthesia recovery)

• The lowest oxygen saturation

  Procedure (from anesthesia induction to anesthesia recovery)

Study Arms (4)

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.

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.

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.

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.

Procedure: nasopharyngeal tube ventilation; Device: oxygen reserve index monitoring

Interventions

face mask ventilation PROCEDURE

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

face mask airway management with oxygen reserve index monitoring; face mask airway management without oxygen reserve index monitoring

nasopharyngeal tube ventilation PROCEDURE

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.

nasopharyngeal tube airway management with oxygen reserve index monitoring; nasopharyngeal tube airway management without oxygen reserve index monitoring

oxygen saturation monitoring DEVICE

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%.

face mask airway management without oxygen reserve index monitoring; nasopharyngeal tube airway management without oxygen reserve index monitoring

oxygen reserve index monitoring DEVICE

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.

face mask airway management with oxygen reserve index monitoring; nasopharyngeal tube airway management with oxygen reserve index monitoring

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female, 18-60 years old
• Scheduled for hysteroscopy
• Predict operation duration more than 10 minutes

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Study Officials

• Zheng Guan, MD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Zheng Guan, MD

CONTACT

0086-13572592715; guanzheng1980@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 27, 2023
• Study Start: February 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2024
• Last Updated: February 1, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)