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EEG Spectral Pattern of Deep Sedation-induced Airway Adverse Effects

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05595798
Enrollment
60
Registered
2022-10-27
Start date
2022-11-30
Completion date
2023-10-31
Last updated
2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural Sedation

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.

Interventions

DIAGNOSTIC_TESTAirmod breathing sound monitoring

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurence of airway obstruction during sedation0.5-2 hoursAirway obstruction detected by the breath sound monitor or capnography
Occurence of apnea event during sedation0.5-2 hoursApnea detected by the breath sound monitor or capnography

Countries

Taiwan

Contacts

Primary ContactChun-Yu Wu
b001089018@tmu.edu.tw886-2-23562158
Backup ContactChun-Yu Wu
886-2-23562158

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026