NCT05595798

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

November 4, 2022

Status Verified

October 1, 2022

Enrollment Period

11 months

First QC Date

October 23, 2022

Last Update Submit

November 2, 2022

Conditions

Procedural Sedation

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Geriatric population

patient with ages above 65-yr

Diagnostic Test: Airmod breathing sound monitoring

Pediatric population

patient with ages between 4-8 year old

Diagnostic Test: Airmod breathing sound monitoring

Interventions

Airmod breathing sound monitoringDIAGNOSTIC_TEST

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

Also known as: Electroencephalographic monitoring, Capnographic monitoring
Geriatric populationPediatric population

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Preoperative active brain conditions (dementia, Parkinsonism, seizure)
  • A history of nasal or oral tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

  • Chun-Yu Wu

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Yu Wu

CONTACT

886-2-23562158b001089018@tmu.edu.tw

Chun-Yu Wu

CONTACT

886-2-23562158

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2022

First Posted

October 27, 2022

Study Start

November 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

November 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

The IPD can be obtained by contacting the corresponding author after the study is published

Shared Documents
CSR
Time Frame
The data will be availabel after publication.
Access Criteria
For research purpose only. The IPD will not be provided for commercial purpose.

Locations

TW(1)