Lumbar Spinal StenosisNCT02625194
The Utility of Oxygen Insufflation During Flexible Fiberoptic Bronchoscope-guided Intubation
A study testing Oxygen in people with Lumbar Spinal Stenosis, run by Yonsei University at 1 site in South Korea.
Trial summary
This study investigate the utility of continuous oxygen insufflation during fiberoptic bronchoscope-guided intubation. One group receives oxygen via suction channel of fiberoptic bronchoscope during intubation. The other group does not receive oxygen during fiberoptic bronchoscope-guided intubation. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2016to 4 Sep 2017
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients who have surgery under general oral endotracheal anesthesia with invasive arterial blood pressure monitoring
Who cannot join
- history of lung disease
- abnormality in chest x-ray
- anticipating difficult intubation
- pregnant women
- who is unable to understand and agree the consent form
Trial locations and contacts
1 site in 1 country.
About this study
This study investigate the utility of continuous oxygen insufflation during fiberoptic bronchoscope-guided intubation.
One group receives oxygen via suction channel of fiberoptic bronchoscope during intubation.
The other group does not receive oxygen during fiberoptic bronchoscope-guided intubation.
Then, the velocity of deoxygenation difference of PaO2(baseline
Read the detailed description
Fiberoptic bronchoscope-guided intubation is a gold standard for intubation of a patient with anticipating difficult airway. This technique takes several minutes without oxygen supply, which results in hypoxia when it prolonged. If continuous supply of oxygen during procedure improve the oxygenation, we can reduce the risk of hypoxemia and increase the safety margin during procedure.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Oxygen
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Oxygen is supplied through suction port during bronchoscope-guided intubation.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen | Experimental | Oxygen is supplied through suction port in bronchoscope during bronchoscope-guided intubation. Receives: Drug: Oxygen |
| Control | No intervention | Bronchoscope-guided intubation is performed without oxygen supply. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity of PaO2 decrease
After administration of anesthetic agents and manual ventilation of 5 minutes, arterial blood sampling is collected. Then bronchoscope-guided intubation performed and arterial blood sample is collected immediately after the intubation completed. Time for intubation (between 1st and 2nd blood sample) is recorded. The difference of PaO2(before \& after intubation) is divided by the time taking for intubation.
Measured: from mask removal to 1st manual ventilation after intubation, up to 5 minute
Secondary outcomes (5)
success of intubation
After 1st trial of intubation, the success of intubation is recorded. If it takes more than 300 sec, it will be considered failure.
Measured: 300 sec after the beginning of intubation
PaO2
arterial blood samples are collected before and after intubation.
Measured: 1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
PaCO2
arterial blood samples are collected before and after intubation.
Measured: 1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
pH
arterial blood samples are collected before and after intubation.
Measured: 1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
visual field
Visual field is evaluated by the blinded observer. It is evaluated as followed;excellent, good, poor, impossible
Measured: throughout the intubation with bronchoscope, upto 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study start1 Jan 2016
- Primary completion4 Sep 2017
- Study completion4 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeong Soo Lee, MD, Study chair, Yonsei University Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625194
- Sponsor's protocol ID
- 3-2015-0218
- Status last verified
- Jul 2019
- First submitted
- 25 Nov 2015
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Roh GU, Kang JG, Han JY, Chang CH. Utility of oxygen insufflation through working channel during fiberoptic intubation in apneic patients: a prospective randomized controlled study. BMC Anesthesiol. 2020 Nov 10;20(1):282. doi: 10.1186/s12871-020-01201-9.
PubMed 33167909
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Oxygen Insufflation During Flexible Fiberoptic Bronchoscope-guided Intubation
- ClinicalTrials.gov ID
- NCT02625194
- Acronym / sponsor ID
- 3-2015-0218
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 4 Sep 2017 (actual)
- Study completion
- 4 Sep 2017 (actual)
- First posted
- 9 Dec 2015 (estimated)
- 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.
This study investigate the utility of continuous oxygen insufflation during fiberoptic bronchoscope-guided intubation.
One group receives oxygen via suction channel of fiberoptic bronchoscope during intubation.
The other group does not receive oxygen during fiberoptic bronchoscope-guided intubation.
Then, the velocity of deoxygenation difference of PaO2(baseline
Detailed description
Fiberoptic bronchoscope-guided intubation is a gold standard for intubation of a patient with anticipating difficult airway. This technique takes several minutes without oxygen supply, which results in hypoxia when it prolonged. If continuous supply of oxygen during procedure improve the oxygenation, we can reduce the risk of hypoxemia and increase the safety margin during procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen | Experimental | Drug: OxygenOxygen is supplied through suction port in bronchoscope during bronchoscope-guided intubation. |
| Control | No intervention | –Bronchoscope-guided intubation is performed without oxygen supply. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who have surgery under general oral endotracheal anesthesia with invasive arterial blood pressure monitoring
Key exclusion criteria (5 listed)
- history of lung disease
- abnormality in chest x-ray
- anticipating difficult intubation
- pregnant women
- who is unable to understand and agree the consent form
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 |
|---|---|---|
| OxygenOxygen is supplied through suction port during bronchoscope-guided intubation. | Drug | Oxygen |
Primary outcome
Velocity of PaO2 decrease
Time frame: from mask removal to 1st manual ventilation after intubation, up to 5 minute
After administration of anesthetic agents and manual ventilation of 5 minutes, arterial blood sampling is collected. Then bronchoscope-guided intubation performed and arterial blood sample is collected immediately after the intubation completed. Time for intubation (between 1st and 2nd blood sample) is recorded. The difference of PaO2(before \& after intubation) is divided by the time taking for intubation.
5 secondary outcomes
success of intubation
Time frame: 300 sec after the beginning of intubation
PaO2
Time frame: 1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
PaCO2
Time frame: 1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
pH
Time frame: 1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute
visual field
Time frame: throughout the intubation with bronchoscope, upto 5 minute
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 9 Jul 2019.
- Derived from this study: PubMed 33167909Roh GU, Kang JG, Han JY, Chang CH. Utility of oxygen insufflation through working channel during fiberoptic intubation in apneic patients: a prospective randomized controlled study. BMC Anesthesiol. 2020 Nov 10;20(1):282. doi: 10.1186/s12871-020-01201-9.
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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.
Jeong Soo Lee, MD study chair
Yonsei University Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Lumbar Spinal Stenosis, 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 5 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 9 Jul 2019. 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?
Velocity of PaO2 decrease (time frame: from mask removal to 1st manual ventilation after intubation, up to 5 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02625194, which also lists 1 linked publication.
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 9 Jul 2019.