EEG Spectral Pattern of Deep Sedation-induced Airway Adverse Effects

Recruiting

• Conditions: Procedural Sedation
• Interventions: Diagnostic Test: Airmod breathing sound monitoring

• Registration Number: NCT05595798
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

To investigate the associations bewteen the sedation level and the airway adverse effects by using the EEG, Airmod breath sound monitor and the capnography.

Detailed Description

Deep sedation is mandatory for many invasive procedures such as the digestive endoscopy, bronchoscopy and cystoscopy. However, deep sedation may induce respiratory adverse effects including airway obstruction, hypoventilation and apnea. These respiratory adverse effects, which may occur in more than 20% of high-risk groups (eg, children, the elderly, and patients with sleep apnea), hence, are the major concerns of the anesthetic care. However, It is difficult for clinicians to objectively quantify the sedation level and find the associations of inadequate sedation level and the occurrence of respiratory adverse effects.

Airway obstruction and respiratory rate decline during deep sedation are conventionally monitored by using capnography(EtCO2 waveform). However, previous studies have tracheal breath sound monitoring can achieve better detection accuracy than the capnography. The novel Airmod smart breathing monitor has the functions of breath sound recording, anti-noise signal processing, event recording and respiratory rate analysis and research. Through the continuous breath sound recording, airway adverse effects during sedation may be detected, and these breathing spectrogram can be presented for image analysis. This is helpful for researcher to identify associations between airway adverse effect and the sedation level.

The state-of-art anesthetic depth is determined by using the electroencephalogram (EEG). Both EEG raw data or the EEG spectrogram graphs may be used for quantify the sedation level with respiratory adverse effects. Accordingly, this study aims to investigate the associations between the sedation level and the airway adverse effects by using the EEG monitor, Airmod breath sound monitor and the capnography.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-23
• Study First Submitted QC: 2022-10-23
• Study First Posted: 2022-10-27
• Study Start: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients undergoing procedural sedation with expected produre time longer than 30 minutes

• Pediatric group: age 4-8 year-old
• Geriatric group: age>= 65 year-old

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Exclusion Criteria

• Preoperative active brain conditions (dementia, Parkinsonism, seizure)
• A history of nasal or oral tumor

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric population	Airmod breathing sound monitoring	patient with ages between 4-8 year old
Geriatric population	Airmod breathing sound monitoring	patient with ages above 65-yr

Primary Outcome Measures

Name	Time	Method
Occurence of airway obstruction during sedation	0.5-2 hours	Airway obstruction detected by the breath sound monitor or capnography
Occurence of apnea event during sedation	0.5-2 hours	Apnea detected by the breath sound monitor or capnography

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan