EEG Spectral Pattern of Deep Sedation-induced Airway Adverse Effects

National Taiwan University

Status: Enrolling

Conditions: Procedural Sedation

Treatments: Diagnostic Test: Airmod breathing sound monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT05595798

202209055DINB

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Geriatric population

Description:

patient with ages above 65-yr

Treatment:

Diagnostic Test: Airmod breathing sound monitoring

Pediatric population

Description:

patient with ages between 4-8 year old

Treatment:

Diagnostic Test: Airmod breathing sound monitoring