Surgical InterventionNCT01467739
Evaluation of the Ambu ® aScope® for Tracheal Intubation in Difficult Airways
A study testing Ambu ® aScope® and a conventional reusable fiberscope in people with Surgical Intervention and Endotracheal Intubation, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate a disposable fiberscope (Ambu ® aScope®) for tracheal intubation in difficult airways due to cervical immobilization by a cervical collar, and compare it to a conventional reusable fiberscope. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Surgical Intervention, Endotracheal Intubation
- What is being tested?
- Ambu ® aScope® and a conventional reusable fiberscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2011to Nov 2011
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients older than 16 years
- ASA 1-2
- BMI < 35 kg/m2
- Surgery requiring general anesthesia with intubation of the trachea
Who cannot join
- Emergency operation
- Patient ASA 3 or more
- BMI above 35 kg/m2
- History of difficult airways
- History of surgery or radiotherapy in head and neck
- Presence of gastro esophageal reflux
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Lausanne Hospitals
Lausanne, Canton of Vaud, 1011
About this study
Official title: Evaluation of the Ambu ® aScope® for Tracheal Intubation During Cervical Spine Immobilization With a Cervical Collar, in Comparison With a Conventional Reusable Fiberscope.
The purpose of this study is to evaluate a disposable fiberscope (Ambu ® aScope®) for tracheal intubation in difficult airways due to cervical immobilization by a cervical collar, and compare it to a conventional reusable fiberscope.
Read the detailed description
Any general anesthesia requiring tracheal intubation for controlled ventilation includes the likelihood of intubation failure and, in case of difficult or impossible mask ventilation, can be life-threatening. In patients with diagnosed or suspected disease of the cervical spine, airway control can be tricky. Indeed, the cervical collar used to secure the cervical spine makes direct laryngoscopy impossible. In elective surgery, the most commonly used technique is fiberoptic intubation, achievable without removing of the cervical collar.
A new disposable fiberscope was recently developed by Ambu ®: the aScope®. It consists of a disposable flexible fiberscopic device, whose distal end is fitted with a camera that can be directed. This device is connected to a separate reusable LCD display. The aScope® is used as a conventional flexible fiberscope to guide the instrumentation of the airway.
With the exception of case reports, all studies of this device in difficult conditions were performed on mannequins.
The investigators propose to assess and validate this device on real patients with difficult airways caused by a rigid cervical collar and compare intubation conditions and time to the gold standard technique, the classical reusable fiberscope.
Induction of general anesthesia is performed by the anesthesiologist responsible for the patient, according to the standards in the anesthesiology department.
The cervical collar is fitted and positioned once the patient is asleep in addition to a dedicated oropharyngeal cannula (Ovassapian fiberoptic intubating airway cannula) in order to guide the aScope® or fiberscope in the oropharynx. The timer is activated once the investigating physician takes the aScope® or fiberscope in his hands. The device is advanced into the airway with visual control on the LCD screen for the aScope® or on an external dedicated screen for the fiberscope. Once in the trachea, the device will serve as a guide for introduction of the orotracheal tube, according to standard fiberscopic intubation technique. Tracheal intubation is confirmed through visualization of the distal end of the tube into the trachea, the onset of an end tidal CO2 curve and auscultation. The timer will be stopped at the onset of the end tidal CO2 curve.
- Conditions
- Surgical Intervention, Endotracheal Intubation
- Being tested
- Ambu ® aScope®, a conventional reusable fiberscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu ® aScope®Device
a conventional reusable fiberscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Ambu ® aScope® | Active comparator | Not described Receives: Device: Ambu ® aScope® |
| a conventional reusable fiberscope. | Active comparator | Not described Receives: Device: a conventional reusable fiberscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the Ambu ® aScope® for tracheal intubation in difficult airways.
Time to reach the carina and Time to obtain an end tidal CO2 curve by aScope in comparison to conventional reusable fiberscope.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionNov 2011
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 Surgical InterventionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schoettker,MD PD, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467739
- Sponsor's protocol ID
- 88/11
- Status last verified
- Dec 2013
- First submitted
- 8 Nov 2011
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Krugel V, Bathory I, Frascarolo P, Schoettker P. Comparison of the single-use Ambu((R)) aScope 2 vs the conventional fibrescope for tracheal intubation in patients with cervical spine immobilisation by a semirigid collar*. Anaesthesia. 2013 Jan;68(1):21-6. doi: 10.1111/anae.12044. Epub 2012 Oct 22.
PubMed 23088837
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ambu ® aScope® for Tracheal Intubation During Cervical Spine Immobilization With a Cervical Collar, in Comparison With a Conventional Reusable Fiberscope.
- ClinicalTrials.gov ID
- NCT01467739
- Acronym / sponsor ID
- 88/11
- Conditions
- Surgical Intervention, Endotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 Nov 2011 (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 purpose of this study is to evaluate a disposable fiberscope (Ambu ® aScope®) for tracheal intubation in difficult airways due to cervical immobilization by a cervical collar, and compare it to a conventional reusable fiberscope.
Detailed description
Any general anesthesia requiring tracheal intubation for controlled ventilation includes the likelihood of intubation failure and, in case of difficult or impossible mask ventilation, can be life-threatening. In patients with diagnosed or suspected disease of the cervical spine, airway control can be tricky. Indeed, the cervical collar used to secure the cervical spine makes direct laryngoscopy impossible. In elective surgery, the most commonly used technique is fiberoptic intubation, achievable without removing of the cervical collar.
A new disposable fiberscope was recently developed by Ambu ®: the aScope®. It consists of a disposable flexible fiberscopic device, whose distal end is fitted with a camera that can be directed. This device is connected to a separate reusable LCD display. The aScope® is used as a conventional flexible fiberscope to guide the instrumentation of the airway.
With the exception of case reports, all studies of this device in difficult conditions were performed on mannequins.
The investigators propose to assess and validate this device on real patients with difficult airways caused by a rigid cervical collar and compare intubation conditions and time to the gold standard technique, the classical reusable fiberscope.
Induction of general anesthesia is performed by the anesthesiologist responsible for the patient, according to the standards in the anesthesiology department.
The cervical collar is fitted and positioned once the patient is asleep in addition to a dedicated oropharyngeal cannula (Ovassapian fiberoptic intubating airway cannula) in order to guide the aScope® or fiberscope in the oropharynx. The timer is activated once the investigating physician takes the aScope® or fiberscope in his hands. The device is advanced into the airway with visual control on the LCD screen for the aScope® or on an external dedicated screen for the fiberscope. Once in the trachea, the device will serve as a guide for introduction of the orotracheal tube, according to standard fiberscopic intubation technique. Tracheal intubation is confirmed through visualization of the distal end of the tube into the trachea, the onset of an end tidal CO2 curve and auscultation. The timer will be stopped at the onset of the end tidal CO2 curve.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambu ® aScope® | Active comparator | Device: Ambu ® aScope® |
| a conventional reusable fiberscope. | Active comparator | Device: a conventional reusable fiberscope |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 16 years
- ASA 1-2
- BMI < 35 kg/m2
- Surgery requiring general anesthesia with intubation of the trachea
Key exclusion criteria (6 listed)
- Emergency operation
- Patient ASA 3 or more
- BMI above 35 kg/m2
- History of difficult airways
- History of surgery or radiotherapy in head and neck
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 |
|---|---|---|
| Ambu ® aScope® | Device | Ambu ® aScope® |
| a conventional reusable fiberscope | Device | a conventional reusable fiberscope. |
Primary outcome
Effectiveness of the Ambu ® aScope® for tracheal intubation in difficult airways.
Time to reach the carina and Time to obtain an end tidal CO2 curve by aScope in comparison to conventional reusable fiberscope.
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 16 Dec 2013.
- Results publication: PubMed 23088837Krugel V, Bathory I, Frascarolo P, Schoettker P. Comparison of the single-use Ambu((R)) aScope 2 vs the conventional fibrescope for tracheal intubation in patients with cervical spine immobilisation by a semirigid collar*. Anaesthesia. 2013 Jan;68(1):21-6. doi: 10.1111/anae.12044. Epub 2012 Oct 22.
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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 Ambu ® aScope® and a conventional reusable fiberscope in people with Surgical Intervention and Endotracheal Intubation, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 4 inclusion and 6 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 16 Dec 2013. 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 Switzerland. 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?
Effectiveness of the Ambu ® aScope® for tracheal intubation in difficult airways.. 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 NCT01467739, 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 16 Dec 2013.