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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05595798
Other study ID # 202209055DINB
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2022
Est. completion date October 2023

Study information

Verified date October 2022
Source National Taiwan University Hospital
Contact Chun-Yu Wu
Phone 886-2-23562158
Email b001089018@tmu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Airmod breathing sound monitoring
Respiratory monitoring and sedation depth monitoring will be applied during procedural sedation.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurence of airway obstruction during sedation Airway obstruction detected by the breath sound monitor or capnography 0.5-2 hours
Primary Occurence of apnea event during sedation Apnea detected by the breath sound monitor or capnography 0.5-2 hours
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