Insertion of a Flexible BronchoscopeOxyInsufflNCT06680648
Oxygen Insufflation Via Flexible Scope
A study testing addition of oxygeninsufflation via working channel of flexible scope and no-oxygen insufflation in people with Insertion of a Flexible Bronchoscope and Airway Management When Secretions Obstruct the Larynx, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insertion of a Flexible Bronchoscope, Airway Management When Secretions Obstruct the Larynx
- What is being tested?
- addition of oxygeninsufflation via working channel of flexible scope and no-oxygen insufflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Nov 2024to 22 Nov 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anesthesiologists attending the airway course "Airwaymanagement for Anaesthesiologists"
- -
Who cannot join
- non acceptance of participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Unoversity Hospital of Copenhagen
Copenhagen, The Capital Region, 2100
About this study
Official title: Oxygen Insufflation Via a Flexible Scope to Remove Secretions and Blood Obstructiong the View When Advancing the Scope Towrds the Trachea
The investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. We provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm H2O which are relatively safe pressure-levels. The endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. The procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. The setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. The procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. Additionally, subjective scores regarding the benefit of using insufflation will be obtained
Read the detailed description
The investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. We provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm H2O which are relatively safe pressure-levels. The endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. The procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. The setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. The procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. Additionally, subjective scores regarding the benefit of using insufflation will be obtained
- Conditions
- Insertion of a Flexible Bronchoscope, Airway Management When Secretions Obstruct the Larynx
- Being tested
- addition of oxygeninsufflation via working channel of flexible scope, no-oxygen insufflation
- Keywords
- Flaxible Scope guided intubation, Fibreoptic intubation, The bleeding airway, The difficult airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
addition of oxygeninsufflation via working channel of flexible scopeProcedure or surgery
addition of oxygeninsufflation via working channel of flexible scope in order to improve visibility when advancing the flexible scope
no-oxygen insufflationProcedure or surgery
no-oxygen insufflation added to the flexible scope while advancing it
| Study group | Role | What they receive |
|---|---|---|
| Insufflation first followed by no-insufflation | Experimental | Not described Receives: Procedure: addition of oxygeninsufflation via working channel of flexible scope |
| no-insufflation first followed by insufflation | Active comparator | Not described Receives: Procedure: no-oxygen insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fraction of bronchoscopic advancements that result in a view of vocal cords (Fully or partial) without the view being obstructed by saliva or blood during the advancement
The fraction in whom The flexible scope is advanced to the trachea with maintained visibility all the time until vocal cord is seen
Measured: 90 seconds
Secondary outcomes (11)
The scope is advanced to the trachea within 2 minutes
The flexible scope is advanced to the trachea with or without maintained visibility
Measured: 2 minutes
Duration until the tip of the scope is in the trachea
Time from the tip of the scope passes the teeth until it is in the trachea
Measured: 0-2 minutes
Operation percieved ease of advancing the scope to the trachea with maintained visibility
Operation percieved ease of advancing the scope to the trachea with maintained visibility, on a visual analogue scale from 1-10, 1 = very easy, 10 = almost impossible, lowest is best
Measured: 2 minutes
Operation percieved ease of advancing the scope to the trachea, overall
Operation percieved ease of advancing the scope to the trachea overall,
, on a visual analogue scale from 1-10, 1 = very easy, 10 = almost impossible, lower score is best.
Measured: 2 minute
The scope is advanced to the trachea within 1 minute
The flexible scope is advanced to the trachea with or without maintained visibility
Measured: 1 minute
unobstructed advancement to the trachea in two minutes
The flexible scope is advanced to the trachea with maintained visibility
Measured: 2 minute
unobstructed advancement to the trachea in 90 seconds
The flexible scope is advanced to the trachea with maintained visibility
Measured: 90 seconds
Obtaining a view of vocal cord(s) without obstruction of the view, obtained in 30 seconds
The fraction of participants in each group who obtain a view of vocal cord(s) without the view being obstructed at any point
Measured: 30 sekunds
Obtaining a view of vocal cord(s) without obstruction of the view, obtained in one minute
The fraction of participants in each group who obtain a view of the vocal cord(s) without the view being obstructed at any point
Measured: 1 minute
Obtaining a view of the vocal cord(s) without obstruction of the view, obtained in 90 seconds
The fraction of particip in each group who obtain a view of the vocal cord(s) without the view being obstructed, Obtained in 90 seconds
Measured: 90 seconds
The fraction of brochoscopic advancements that results in Unobstructed advancement to the trachea in one minute
The fraction of the attempts when the flexible scope is advanced to the trachea with maintained visibility
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start21 Nov 2024
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
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 Insertion of a Flexible BronchoscopeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- one arm is oxygen insufflation first followed by no-insufflation the second arm is: no insufflation followed by oxygen insufflation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Seltz Kristensen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680648
- Sponsor's protocol ID
- OxygenInsufflation_F-24066560
- Acronym
- OxyInsuffl
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garioud A, Kristensen MS. Oxygen insufflation via the working channel during tracheal intubation guided by a flexible optical scope and benefits, dangers, and future of the method: a narrative review. BJA Open. 2024 Oct 17;12:100346. doi: 10.1016/j.bjao.2024.100346. eCollection 2024 Dec.
PubMed 39469423
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Insufflation Via a Flexible Scope to Remove Secretions and Blood Obstructiong the View When Advancing the Scope Towrds the Trachea
- ClinicalTrials.gov ID
- NCT06680648
- Acronym / sponsor ID
- OxyInsuffl / OxygenInsufflation_F-24066560
- Conditions
- Insertion of a Flexible Bronchoscope, Airway Management When Secretions Obstruct the Larynx
- Keywords
- Flaxible Scope guided intubation, Fibreoptic intubation, The bleeding airway, The difficult airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 8 Nov 2024 (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 investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. We provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm H2O which are relatively safe pressure-levels. The endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. The procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. The setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. The procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. Additionally, subjective scores regarding the benefit of using insufflation will be obtained
Detailed description
The investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. We provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm H2O which are relatively safe pressure-levels. The endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. The procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. The setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. The procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. Additionally, subjective scores regarding the benefit of using insufflation will be obtained
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- one arm is oxygen insufflation first followed by no-insufflation the second arm is: no insufflation followed by oxygen insufflation
| Arm | Type | Receives |
|---|---|---|
| Insufflation first followed by no-insufflation | Experimental | Procedure: addition of oxygeninsufflation via working channel of flexible scope |
| no-insufflation first followed by insufflation | Active comparator | Procedure: no-oxygen insufflation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Anesthesiologists attending the airway course "Airwaymanagement for Anaesthesiologists"
- -
Key exclusion criteria (1 listed)
- non acceptance of participation
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 |
|---|---|---|
| addition of oxygeninsufflation via working channel of flexible scopeaddition of oxygeninsufflation via working channel of flexible scope in order to improve visibility when advancing the flexible scope | Procedure or surgery | Insufflation first followed by no-insufflation |
| no-oxygen insufflationno-oxygen insufflation added to the flexible scope while advancing it | Procedure or surgery | no-insufflation first followed by insufflation |
Primary outcome
The fraction of bronchoscopic advancements that result in a view of vocal cords (Fully or partial) without the view being obstructed by saliva or blood during the advancement
Time frame: 90 seconds
The fraction in whom The flexible scope is advanced to the trachea with maintained visibility all the time until vocal cord is seen
11 secondary outcomes
The scope is advanced to the trachea within 2 minutes
Time frame: 2 minutes
Duration until the tip of the scope is in the trachea
Time frame: 0-2 minutes
Operation percieved ease of advancing the scope to the trachea with maintained visibility
Time frame: 2 minutes
Operation percieved ease of advancing the scope to the trachea, overall
Time frame: 2 minute
The scope is advanced to the trachea within 1 minute
Time frame: 1 minute
unobstructed advancement to the trachea in two minutes
Time frame: 2 minute
unobstructed advancement to the trachea in 90 seconds
Time frame: 90 seconds
Obtaining a view of vocal cord(s) without obstruction of the view, obtained in 30 seconds
Time frame: 30 sekunds
Obtaining a view of vocal cord(s) without obstruction of the view, obtained in one minute
Time frame: 1 minute
Obtaining a view of the vocal cord(s) without obstruction of the view, obtained in 90 seconds
Time frame: 90 seconds
The fraction of brochoscopic advancements that results in Unobstructed advancement to the trachea in one minute
Time frame: 1 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 26 Oct 2026.
- Background: PubMed 39469423Garioud A, Kristensen MS. Oxygen insufflation via the working channel during tracheal intubation guided by a flexible optical scope and benefits, dangers, and future of the method: a narrative review. BJA Open. 2024 Oct 17;12:100346. doi: 10.1016/j.bjao.2024.100346. eCollection 2024 Dec.
- Individual participant dataSharing planned: No
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 addition of oxygeninsufflation via working channel of flexible scope and no-oxygen insufflation in people with Insertion of a Flexible Bronchoscope and Airway Management When Secretions Obstruct the Larynx, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 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 26 Oct 2026. 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 Denmark. 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 fraction of bronchoscopic advancements that result in a view of vocal cords (Fully or partial) without the view being obstructed by saliva or blood during the advancement (time frame: 90 seconds). 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 NCT06680648, 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 26 Oct 2026.