IntubationNCT02210338
A Comparison of the C-mac and Bonfils Intubation Fibrescope
A study testing Karl Storz C-MAC and Bonfils Intubation Fibrescope in people with Intubation and Airway, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The study aims to determine the better device to facilitate intubation in patients with a limited neck movement and small mouth opening. This may help anesthesiology as well as emergency medicine practitioners and departments to decide when choosing between these two conceptually similar device. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Intubation, Airway
- What is being tested?
- Karl Storz C-MAC and Bonfils Intubation Fibrescope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2014to Mar 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective surgery under general anaesthesia who require endotracheal intubation
Who cannot join
- Patients with history of previous difficult endotracheal intubation
- Patients with two or more predictors of difficult mask ventilation or difficult intubation or the combination of both
- Patients with ASA (American Society of Anesthesiologists) grading of III and above are excluded from the study, as well as patients with 2 or more predictors for difficult mask ventilation or difficult intubation or the combination of both.
- Patients needing a rapid sequence induction for rapid securement of the airway
- Pregnant women
- Patients below the age of 21 years old
- Patients unfit to give consent
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, Singapore, 169608
Theodore GL Wong
Hairil R Abdullah
About this study
Official title: A Comparison of the C-mac and Bonfils Intubation Fibrescope for Tracheal Intubation in Patients With a Simulated Difficult Airway
The study aims to determine the better device to facilitate intubation in patients with a limited neck movement and small mouth opening. This may help anesthesiology as well as emergency medicine practitioners and departments to decide when choosing between these two conceptually similar device. The hypothesis to be tested is that the C-MAC® is more superior when compared to the Bonfils Intubation Fibrescope in success of intubation, time to intubation and complication rate in patients with a fixed cervical collar.
- Conditions
- Intubation, Airway
- Being tested
- Karl Storz C-MAC, Bonfils Intubation Fibrescope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karl Storz C-MACDevice
Bonfils Intubation FibrescopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Karl Storz C-MAC | Experimental | Intubation of patient using the Karl Storz C-MAC video laryngoscope Receives: Device: Karl Storz C-MAC |
| Bonfils Intubation Fibrescope | Experimental | Intubation of patient using Bonfils Intubation Fibrescope Receives: Device: Bonfils Intubation Fibrescope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of intubation on first attempt
A rigid cervical collar will to each patient to stimulate a difficult airway and standard induction of general anaesthesia will be carried out. Adequate muscle relaxation will be confirmed by the use of a standard neuromuscular Train-of-Four monitor, showing no twitch. Intubation will then proceed with the assigned airway device. A successful outcome at intubation will involve being able to pass an appropriately sized endotracheal tube pass the vocal cords into the trachea on the first try, as evidenced by the presence of end tidal carbon dioxide on a capnograph.
Measured: up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after first attempt at intubation
Secondary outcomes (1)
Time taken to successful intubation
A rigid cervical collar will to each patient to stimulate a difficult airway and standard induction of general anaesthesia will be carried out. Adequate muscle relaxation will be confirmed by the use of a standard neuromuscular Train-of-Four monitor, showing no twitch. Time to successful intubation will then be measured from the first handling of the airway device, until successful intubation with an endotracheal tube is confirmed by the presence of end tidal carbon dioxide on a capnograph trace.
Measured: up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after successful intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
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 IntubationStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theodore GL Wong, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210338
- Sponsor's protocol ID
- sghan-cb01
- Status last verified
- Apr 2016
- First submitted
- 5 Aug 2014
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdullah HR, Li-Ming T, Marriott A, Wong TG. A comparison between the Bonfils Intubation Fiberscope and McCoy laryngoscope for tracheal intubation in patients with a simulated difficult airway. Anesth Analg. 2013 Nov;117(5):1217-20. doi: 10.1213/ANE.0b013e3182a46fa9.
PubMed 24029854
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the C-mac and Bonfils Intubation Fibrescope for Tracheal Intubation in Patients With a Simulated Difficult Airway
- ClinicalTrials.gov ID
- NCT02210338
- Acronym / sponsor ID
- sghan-cb01
- Conditions
- Intubation, Airway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 6 Aug 2014 (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.
The study aims to determine the better device to facilitate intubation in patients with a limited neck movement and small mouth opening. This may help anesthesiology as well as emergency medicine practitioners and departments to decide when choosing between these two conceptually similar device. The hypothesis to be tested is that the C-MAC® is more superior when compared to the Bonfils Intubation Fibrescope in success of intubation, time to intubation and complication rate in patients with a fixed cervical collar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Karl Storz C-MAC | Experimental | Device: Karl Storz C-MACIntubation of patient using the Karl Storz C-MAC video laryngoscope |
| Bonfils Intubation Fibrescope | Experimental | Device: Bonfils Intubation FibrescopeIntubation of patient using Bonfils Intubation Fibrescope |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective surgery under general anaesthesia who require endotracheal intubation
Key exclusion criteria (7 listed)
- Patients with history of previous difficult endotracheal intubation
- Patients with two or more predictors of difficult mask ventilation or difficult intubation or the combination of both
- Patients with ASA (American Society of Anesthesiologists) grading of III and above are excluded from the study, as well as patients with 2 or more predictors for difficult mask ventilation or difficult intubation or the combination of both.
- Patients needing a rapid sequence induction for rapid securement of the airway
- Pregnant women
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 |
|---|---|---|
| Karl Storz C-MAC | Device | Karl Storz C-MAC |
| Bonfils Intubation Fibrescope | Device | Bonfils Intubation Fibrescope |
Primary outcome
Success of intubation on first attempt
Time frame: up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after first attempt at intubation
A rigid cervical collar will to each patient to stimulate a difficult airway and standard induction of general anaesthesia will be carried out. Adequate muscle relaxation will be confirmed by the use of a standard neuromuscular Train-of-Four monitor, showing no twitch. Intubation will then proceed with the assigned airway device. A successful outcome at intubation will involve being able to pass an appropriately sized endotracheal tube pass the vocal cords into the trachea on the first try, as evidenced by the presence of end tidal carbon dioxide on a capnograph.
1 secondary outcome
Time taken to successful intubation
Time frame: up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after successful intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Background: PubMed 24029854Abdullah HR, Li-Ming T, Marriott A, Wong TG. A comparison between the Bonfils Intubation Fiberscope and McCoy laryngoscope for tracheal intubation in patients with a simulated difficult airway. Anesth Analg. 2013 Nov;117(5):1217-20. doi: 10.1213/ANE.0b013e3182a46fa9.
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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.
Theodore GL Wong principal investigator
Singapore General 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 Karl Storz C-MAC and Bonfils Intubation Fibrescope in people with Intubation and Airway, run by Singapore General Hospital at 1 site in Singapore.
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 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: status not confirmed, as of the sponsor's last update on 28 Apr 2016. 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 Singapore. 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 Theodore GL Wong (+6598203675, theodore.wong.g.l@sgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of intubation on first attempt (time frame: up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after first attempt at 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 NCT02210338, 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 28 Apr 2016.