EEG Spectral Pattern of Deep Sedation-induced Airway Adverse Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-10-31

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.

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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.

Conditions

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Procedural Sedation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Geriatric population

patient with ages above 65-yr

Airmod breathing sound monitoring

Intervention Type DIAGNOSTIC_TEST

Respiratory monitoring and sedation depth monitoring will be applied during procedural sedation.

Pediatric population

patient with ages between 4-8 year old

Airmod breathing sound monitoring

Intervention Type DIAGNOSTIC_TEST

Respiratory monitoring and sedation depth monitoring will be applied during procedural sedation.

Interventions

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Airmod breathing sound monitoring

Respiratory monitoring and sedation depth monitoring will be applied during procedural sedation.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Electroencephalographic monitoring Capnographic monitoring

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