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.

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

Study Overview

• Status: Recruiting
• Conditions: Procedural Sedation
• Intervention / Treatment: Diagnostic test: Airmod breathing sound monitoring

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Chun-Yu Wu; Phone Number: 886-2-23562158; Email: b001089018@tmu.edu.tw
• Study Contact Backup: Name: Chun-Yu Wu; Phone Number: 886-2-23562158

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chun-Yu Wu; Phone Number: 886-2-23562158

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Two patient groups of higher risk for invasive procedural sedation will be investigated, namely the pediatric patients and geriatric patients.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Geriatric population; patient with ages above 65-yr	Diagnostic test: Airmod breathing sound monitoring; Respiratory monitoring and sedation depth monitoring will be applied during procedural sedation.; Other Names: Electroencephalographic monitoring; Capnographic monitoring
Pediatric population; patient with ages between 4-8 year old	Diagnostic test: Airmod breathing sound monitoring; Respiratory monitoring and sedation depth monitoring will be applied during procedural sedation.; Other Names: Electroencephalographic monitoring; Capnographic monitoring

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: October 23, 2022
• First Submitted That Met QC Criteria: October 23, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 202209055DINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The IPD can be obtained by contacting the corresponding author after the study is published
• IPD Sharing Time Frame: The data will be availabel after publication.
• IPD Sharing Access Criteria: For research purpose only. The IPD will not be provided for commercial purpose.
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No