EEG Spectral Pattern of Deep Sedation-induced Airway Adverse Effects

Study Overview
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Brief Summary
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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
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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.

Official Title
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Associations Between Breath Sound Frequency Pattern, Capnography and Electroencephalographic Density Spectrum Array During Deep Sedation in High Risk Patients.

Conditions
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Procedural Sedation

Intervention / Treatment
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* Diagnostic Test: Airmod breathing sound monitoring


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Preoperative active brain conditions (dementia, Parkinsonism, seizure) A history of nasal or oral tumor

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Geriatric population<br>patient with ages above 65-yr | Diagnostic Test: Airmod breathing sound monitoring<br>* Respiratory monitoring and sedation depth monitoring will be applied during procedural sedation.<br>* Other names: Capnographic monitoring;|
| Pediatric population<br>patient with ages between 4-8 year old | Diagnostic Test: Airmod breathing sound monitoring<br>* Respiratory monitoring and sedation depth monitoring will be applied during procedural sedation.<br>* Other names: Capnographic monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of airway obstruction during sedation | Airway obstruction detected by the breath sound monitor or capnography | 0.5-2 hours | 
| Occurence of apnea event during sedation | Apnea detected by the breath sound monitor or capnography | 0.5-2 hours |