Intubation; Difficult or FailedVIFLEXTIPORNCT05429125
Flexible Tip Bougie vs Tube With Stylet for Intubation With Videolaryngoscopy.
A study testing Endotracheal Tube with Stylet and Flexible Tip Bougie in people with Intubation; Difficult or Failed, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
Trial summary
Although VLs improve glottic visualization, on many occasions it may not be accompanied by intubation at the first attempt, because the endotracheal tube has to pass a sharp angle to enter the trachea. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Endotracheal Tube with Stylet and Flexible Tip Bougie
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jun 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Patients with anticipated difficult airway requiring intubation under with a videolaryngoscopy
- Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.
Who cannot join
- Pregnancy
- age <18 years
- refusal of the patient
- patient's respiratory failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University Clinical Hospital of Santiago de Compostela
Santiago de Compostela, A Coruña, 15866
Manuel Taboada Muñiz, Ph.D., +34678195618, manutabo@yahoo.es
María Teresa Cabaleiro Ocampo, +34 981 951 628
About this study
Official title: A Randomized Comparison Between the Flexible Tip Bougie vs Tube With Stylet for First-attempt Intubation Success With the C-MAC Videolaryngoscopy in Patients With Anticipated Difficult Airway
Although VLs improve glottic visualization, on many occasions it may not be accompanied by intubation at the first attempt, because the endotracheal tube has to pass a sharp angle to enter the trachea. To avoid this limitation, a new flexible tip bougie is designed to flexibly navigate the distal tip and help facilitate precise insertion of the endotracheal tube in the trachea. The flexible tip bougie has an integrated slider along the surface which moves the tip anterior and posterior while the pre-curved distal portion of shaft allows the angulation to provide anterior flexion. This new flexible tip bougie could be used as a rescue when first intubation failure using the videolaryngoscopy, or as a first option to improve the percentage of patients intubated at the first attempt.
Read the detailed description
The purpose of this prospective randomized study is to compare successful intubation on the first attempt with the new flexible tip bougie versus endotracheal tube with stylet during awake intubation with videolaryngoscopy in patients with anticipated difficult airway.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Endotracheal Tube with Stylet, Flexible Tip Bougie
- Keywords
- intubation, difficult airway, videolaryngoscope, operating room, Awake intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal Tube with StyletDevice
Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet.
Flexible Tip BougieDevice
Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal Tube with Stylet | Active comparator | Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet. Receives: Device: Endotracheal Tube with Stylet |
| Flexible Tip Bougie | Active comparator | Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie. Receives: Device: Flexible Tip Bougie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the first attempt intubation success rate (percentage)
To compare the difference in the first attempt intubation success rate (percentage) with the two differents devices compared.
Measured: During intubation
Secondary outcomes (6)
Difference in the overall intubation success rate (percentage)
To compare the difference overall intubation success rate (percentage) with the two differents devices compared.
Measured: During intubation
Difference in the incidence of complications (percentage)
To compare the difference in complications (percentage) with the two different devices compared:
Hypoxemia (SpO2) < 90 %, Hypoxemia severe (SpO2) < 80 %, Hypotension defined as systolic blood pressure less than 80 mm Hg, Severe hypotension defined as systolic blood pressure less than 65 mm Hg, Cardiac arrest, death during intubation, Moderate or difficult intubation, oesophageal intubation, pulmonary aspiration, dental injuries.
Measured: Participants will be followed from the beginning of the intervention to 30 minutes after the intervention
Difficulty of intubation
Operator-assessed subjective difficulty of intubation by means of a special analogue numerical scale from 0 to 10, where 0=no subjective difficulty and 10=maximal subjective difficulty
Measured: During intubation
Modified Cormack-Lehane grade of glottic view
Modified Cormack-Lehane grade of glottic view:
I: full view of the glottis IIa: partial view of the glottis IIb: arytenoid or posterior part of the vocal cords just visible III: only epiglottis visible IV: neither glottis nor epiglottis visible
Measured: During intubation
Additional airway equipment
Need for additional airway equipment
Measured: During intubation
Number of intubation attempts
Number of intubation attempts
Measured: During intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start17 Jun 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Taboada Muñiz, Hospital Clinico Universitario de Santiago
- Investigators
- Manuel Taboada Muñiz, Ph.D., Principal investigator, University Clinical Hospital of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429125
- Sponsor's protocol ID
- VIDEOLAR-FLEXTIP-OR
- Acronym
- VIFLEXTIPOR
- Status last verified
- Dec 2024
- First submitted
- 17 Jun 2022
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data types: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved T ypes of analyses: For scientific purpose Mechanisms of data availability: With investigator support
Publications
Ruetzler K, Smereka J, Abelairas-Gomez C, Frass M, Dabrowski M, Bialka S, Misiolek H, Plusa T, Robak O, Aniolek O, Ladny JR, Gorczyca D, Ahuja S, Szarpak L. Comparison of the new flexible tip bougie catheter and standard bougie stylet for tracheal intubation by anesthesiologists in different difficult airway scenarios: a randomized crossover trial. BMC Anesthesiol. 2020 Apr 20;20(1):90. doi: 10.1186/s12871-020-01009-7.
PubMed 32312225Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496.
PubMed 29800096
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Between the Flexible Tip Bougie vs Tube With Stylet for First-attempt Intubation Success With the C-MAC Videolaryngoscopy in Patients With Anticipated Difficult Airway
- ClinicalTrials.gov ID
- NCT05429125
- Acronym / sponsor ID
- VIFLEXTIPOR / VIDEOLAR-FLEXTIP-OR
- Conditions
- Intubation; Difficult or Failed
- Keywords
- intubation, difficult airway, videolaryngoscope, operating room, Awake intubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jun 2022 (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.
Although VLs improve glottic visualization, on many occasions it may not be accompanied by intubation at the first attempt, because the endotracheal tube has to pass a sharp angle to enter the trachea. To avoid this limitation, a new flexible tip bougie is designed to flexibly navigate the distal tip and help facilitate precise insertion of the endotracheal tube in the trachea. The flexible tip bougie has an integrated slider along the surface which moves the tip anterior and posterior while the pre-curved distal portion of shaft allows the angulation to provide anterior flexion. This new flexible tip bougie could be used as a rescue when first intubation failure using the videolaryngoscopy, or as a first option to improve the percentage of patients intubated at the first attempt.
Detailed description
The purpose of this prospective randomized study is to compare successful intubation on the first attempt with the new flexible tip bougie versus endotracheal tube with stylet during awake intubation with videolaryngoscopy in patients with anticipated difficult airway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal Tube with Stylet | Active comparator | Device: Endotracheal Tube with StyletPatients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet. |
| Flexible Tip Bougie | Active comparator | Device: Flexible Tip BougiePatients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- Patients with anticipated difficult airway requiring intubation under with a videolaryngoscopy
- Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.
Key exclusion criteria (4 listed)
- Pregnancy
- age <18 years
- refusal of the patient
- patient's respiratory failure
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 |
|---|---|---|
| Endotracheal Tube with StyletPatients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet. | Device | Endotracheal Tube with Stylet |
| Flexible Tip BougiePatients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie. | Device | Flexible Tip Bougie |
Primary outcome
Difference in the first attempt intubation success rate (percentage)
Time frame: During intubation
To compare the difference in the first attempt intubation success rate (percentage) with the two differents devices compared.
6 secondary outcomes
Difference in the overall intubation success rate (percentage)
Time frame: During intubation
Difference in the incidence of complications (percentage)
Time frame: Participants will be followed from the beginning of the intervention to 30 minutes after the intervention
Difficulty of intubation
Time frame: During intubation
Modified Cormack-Lehane grade of glottic view
Time frame: During intubation
Additional airway equipment
Time frame: During intubation
Number of intubation attempts
Time frame: During intubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Background: PubMed 32312225Ruetzler K, Smereka J, Abelairas-Gomez C, Frass M, Dabrowski M, Bialka S, Misiolek H, Plusa T, Robak O, Aniolek O, Ladny JR, Gorczyca D, Ahuja S, Szarpak L. Comparison of the new flexible tip bougie catheter and standard bougie stylet for tracheal intubation by anesthesiologists in different difficult airway scenarios: a randomized crossover trial. BMC Anesthesiol. 2020 Apr 20;20(1):90. doi: 10.1186/s12871-020-01009-7.
- Background: PubMed 29800096Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496.
- Individual participant dataSharing planned: Yes. Data types: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved T ypes of analyses: For scientific purpose Mechanisms of data availability: With investigator support
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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.
Manuel Taboada Muñiz, Ph.D. principal investigator
University Clinical Hospital of Santiago de Compostela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal Tube with Stylet and Flexible Tip Bougie in people with Intubation; Difficult or Failed, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 31 Dec 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuel Taboada Muñiz, Ph.D. (0034-981950674, manutabo@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the first attempt intubation success rate (percentage) (time frame: During intubation). 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 NCT05429125, which also lists 2 linked publications.
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 31 Dec 2024.