Procedural SedationNCT05595798
EEG Spectral Pattern of Deep Sedation-induced Airway Adverse Effects
An observational study of Procedural Sedation, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- Airmod breathing sound monitoring
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2022to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Two patient groups of higher risk for invasive procedural sedation will be investigated, namely the pediatric patients and geriatric patients.
Who may be able to join
- 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
Who cannot join
- Preoperative active brain conditions (dementia, Parkinsonism, seizure)
- A history of nasal or oral tumor
Trial locations and contacts
1 site in 1 country.
Chun-Yu Wu contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chun-Yu Wu, 886-2-23562158
About this study
Official title: 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.
Read the 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.
- Conditions
- Procedural Sedation
- Being tested
- Airmod breathing sound monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airmod breathing sound monitoringDiagnostic test
Also called Electroencephalographic monitoring, Capnographic monitoring
Respiratory monitoring and sedation depth monitoring will be applied during procedural sedation.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric population | patient with ages above 65-yr Receives: Diagnostic Test: Airmod breathing sound monitoring | |
| Pediatric population | patient with ages between 4-8 year old Receives: Diagnostic Test: Airmod breathing sound monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of airway obstruction during sedation
Airway obstruction detected by the breath sound monitor or capnography
Measured: 0.5-2 hours
Occurence of apnea event during sedation
Apnea detected by the breath sound monitor or capnography
Measured: 0.5-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study startNov 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595798
- Sponsor's protocol ID
- 202209055DINB
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD can be obtained by contacting the corresponding author after the study is published
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Breath Sound Frequency Pattern, Capnography and Electroencephalographic Density Spectrum Array During Deep Sedation in High Risk Patients.
- ClinicalTrials.gov ID
- NCT05595798
- Acronym / sponsor ID
- 202209055DINB
- Conditions
- Procedural Sedation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geriatric population | – | Diagnostic Test: Airmod breathing sound monitoringpatient with ages above 65-yr |
| Pediatric population | – | Diagnostic Test: Airmod breathing sound monitoringpatient with ages between 4-8 year old |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Two patient groups of higher risk for invasive procedural sedation will be investigated, namely the pediatric patients and geriatric patients.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Preoperative active brain conditions (dementia, Parkinsonism, seizure)
- A history of nasal or oral tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airmod breathing sound monitoringAlso: Electroencephalographic monitoring, Capnographic monitoringRespiratory monitoring and sedation depth monitoring will be applied during procedural sedation. | Diagnostic test | Geriatric population, Pediatric population |
Primary outcome
Occurence of airway obstruction during sedation
Time frame: 0.5-2 hours
Airway obstruction detected by the breath sound monitor or capnography
Occurence of apnea event during sedation
Time frame: 0.5-2 hours
Apnea detected by the breath sound monitor or capnography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: Yes. The IPD can be obtained by contacting the corresponding author after the study is published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Yu Wu contact
Chun-Yu Wu principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Procedural Sedation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Yu Wu (886-2-23562158, b001089018@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of airway obstruction during sedation (time frame: 0.5-2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.