Awake Fiberoptic Bronchoscope Guided IntubationNCT05022056
Impact of High-flow Nasal Oxygen During Awake Fiberoptic Bronchoscope Guided Intubation: A Retrospective Study
An observational study of Awake Fiberoptic Bronchoscope Guided Intubation, run by Yonsei University at 1 site in South Korea.
Trial summary
Retrospective data collection. The aim of this study is to investigate impact of high-flow nasal oxygen on safety(lowest oxygen saturation), efficiency (intubation time, need for multiple attempts) in patients underwent awake fiberoptic bronchoscope guided intubation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Awake Fiberoptic Bronchoscope Guided Intubation
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2021to Oct 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent awake fiberoptic bronchoscope guided intubation for surgery
Who may be able to join
- 1.Patients who underwent awake fiberoptic bronchoscope guided intubation for surgery
Who cannot join
- Cases in which other procedures (e.g. arterial line cannulation) were performed prior to endotracheal intubation after entering operation room
- Patients with Incomplete records of oxygen saturation, attempt number, and time taken for awake intubation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul
Hye Jin Kim, 82-2-2224-4464, jackiedi@yuhs.ac
About this study
Retrospective data collection. The aim of this study is to investigate impact of high-flow nasal oxygen on safety(lowest oxygen saturation), efficiency (intubation time, need for multiple attempts) in patients underwent awake fiberoptic bronchoscope guided intubation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-procedural lowest saturation
Intra-procedural lowest saturation: lowest oxygen saturation on pulse oximetry during awake intubation
Measured: Intra-procedural lowest saturation
need for multiple attempts
need for multiple attempts : more than 2 attempts needed during awake intubation
Measured: Intra-procedural (need for multiple attempts : during awake intubation)
time taken for awake intubation
Time taken for awake intubation: time from entering the operating room to completion of awake endotracheal intubation
Measured: Intra-procedural (Time taken for awake intubation: time from entering the operating room to completion of awake endotracheal intubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awake Fiberoptic Bronchoscope Guided IntubationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022056
- Sponsor's protocol ID
- 4-2021-0901
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High-flow Nasal Oxygen During Awake Fiberoptic Bronchoscope Guided Intubation: A Retrospective Study
- ClinicalTrials.gov ID
- NCT05022056
- Acronym / sponsor ID
- 4-2021-0901
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 26 Aug 2021 (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.
Retrospective data collection. The aim of this study is to investigate impact of high-flow nasal oxygen on safety(lowest oxygen saturation), efficiency (intubation time, need for multiple attempts) in patients underwent awake fiberoptic bronchoscope guided intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent awake fiberoptic bronchoscope guided intubation for surgery
Key inclusion criteria (1 listed)
- 1.Patients who underwent awake fiberoptic bronchoscope guided intubation for surgery
Key exclusion criteria (2 listed)
- Cases in which other procedures (e.g. arterial line cannulation) were performed prior to endotracheal intubation after entering operation room
- Patients with Incomplete records of oxygen saturation, attempt number, and time taken for awake intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intra-procedural lowest saturation
Time frame: Intra-procedural lowest saturation
Intra-procedural lowest saturation: lowest oxygen saturation on pulse oximetry during awake intubation
need for multiple attempts
Time frame: Intra-procedural (need for multiple attempts : during awake intubation)
need for multiple attempts : more than 2 attempts needed during awake intubation
time taken for awake intubation
Time frame: Intra-procedural (Time taken for awake intubation: time from entering the operating room to completion of awake endotracheal intubation)
Time taken for awake intubation: time from entering the operating room to completion of awake endotracheal intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: Undecided
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.
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 Awake Fiberoptic Bronchoscope Guided Intubation, run by Yonsei University at 1 site in South Korea.
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 1 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 26 Aug 2021. 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 South Korea. 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 Hye Jin Kim (82-2-2224-4464, jackiedi@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-procedural lowest saturation (time frame: Intra-procedural lowest saturation). The study lists 3 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 26 Aug 2021.