Foreign BodiesNCT03892408
High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial
A study testing Optiflow ™ in people with Foreign Bodies and Tumor, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on apnea in patients undergoing general anesthesia with rigid bronchoscopy compared with standard anesthesia methods. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Foreign Bodies, Tumor, Stenosis Trachea
- What is being tested?
- Optiflow ™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Apr 2019to 19 Aug 2022
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope
- 2. Patients aged 19 or older who meet American Society of Anesthesiologists (ASA) physical class 2-4
Who cannot join
- 1. Patients with dementia or cognitive impairment
- 2. pregnant women
- 3. Patients undergoing extracorporeal membrane oxygenation (ECMO)
- 4. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
- 5. Patients with current maxillofacial trauma or basal skull fracture
- 6. Patients who had previously undergone rigid bronchoscopy / surgery
- 7. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on apnea in patients undergoing general anesthesia with rigid bronchoscopy compared with standard anesthesia methods.
- Conditions
- Foreign Bodies, Tumor, Stenosis Trachea, Bronchus Tumour
- Being tested
- Optiflow ™
- Medical subject headings
- Foreign Bodies, Neoplasms, Tracheal Stenosis, Bronchial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optiflow ™Device
supply of 100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) plus standard oxygen supply through rigid bronchoscope during apnea period.
| Study group | Role | What they receive |
|---|---|---|
| Optiflow | Experimental | 100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) Receives: Device: Optiflow ™ |
| Standard | No intervention | standard anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the lowest oxygen saturation
the lowest value of oxygen saturation measured percutaneously at extremity.
Measured: apnea period during the rigidbroscopic procedure/surgery
Secondary outcomes (5)
Hypoxia occurs the first time
Measured: intraoperative (The time taken to reach the point at which peripheral oxygen saturation fell below 90 for the first time immediately after the onset of apnea)
End-tidal carbon dioxide partial pressure
Measured: Intraoperative (end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea)
Arterial oxygen / carbon dioxide partial pressure
Measured: shortly before start of apnea (within 30 seconds)
Arterial oxygen / carbon dioxide partial pressure
Measured: shortly after end of apnea (within 30 seconds)
hypoxemia related surgical interruptions
Measured: 4) hypoxemia related surgical interruptions during apneic period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start21 Apr 2019
- Primary completion19 Aug 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foreign BodiesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective Randomized, open label Trial
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892408
- Sponsor's protocol ID
- 1-2019-0005
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03892408
- Acronym / sponsor ID
- 1-2019-0005
- Conditions
- Foreign Bodies, Tumor, Stenosis Trachea, Bronchus Tumour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 21 Apr 2019 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 27 Mar 2019 (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.
The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on apnea in patients undergoing general anesthesia with rigid bronchoscopy compared with standard anesthesia methods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective Randomized, open label Trial
| Arm | Type | Receives |
|---|---|---|
| Optiflow | Experimental | Device: Optiflow ™100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) |
| Standard | No intervention | –standard anesthesia |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope
- 2. Patients aged 19 or older who meet American Society of Anesthesiologists (ASA) physical class 2-4
Key exclusion criteria (7 listed)
- 1. Patients with dementia or cognitive impairment
- 2. pregnant women
- 3. Patients undergoing extracorporeal membrane oxygenation (ECMO)
- 4. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery
- 5. Patients with current maxillofacial trauma or basal skull fracture
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 |
|---|---|---|
| Optiflow ™supply of 100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) plus standard oxygen supply through rigid bronchoscope during apnea period. | Device | Optiflow |
Primary outcome
the lowest oxygen saturation
Time frame: apnea period during the rigidbroscopic procedure/surgery
the lowest value of oxygen saturation measured percutaneously at extremity.
5 secondary outcomes
Hypoxia occurs the first time
Time frame: intraoperative (The time taken to reach the point at which peripheral oxygen saturation fell below 90 for the first time immediately after the onset of apnea)
End-tidal carbon dioxide partial pressure
Time frame: Intraoperative (end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea)
Arterial oxygen / carbon dioxide partial pressure
Time frame: shortly before start of apnea (within 30 seconds)
Arterial oxygen / carbon dioxide partial pressure
Time frame: shortly after end of apnea (within 30 seconds)
hypoxemia related surgical interruptions
Time frame: 4) hypoxemia related surgical interruptions during apneic period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optiflow ™ in people with Foreign Bodies and Tumor, 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 13 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the lowest oxygen saturation (time frame: apnea period during the rigidbroscopic procedure/surgery). 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 13 Jun 2024.