Airway ManagementNCT03109678
A Comparison of the Intubating Laryngeal Mask FASTRACH™ and the Intubating Laryngeal Mask Ambu Aura-i™
A study testing Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™, Crossover Ambu Aura-i™ / LMA ETT™ and Crossover FASTRACH™ / Rüsch Super Safety Silk™ in people with Airway Management and Laryngeal Mask Airway, run by Asklepios Kliniken Hamburg GmbH.
Trial summary
The intubating laryngeal mask Fastrach™ is considered a gold standard for blind intubation as well as for fibreoptic guided intubation via a laryngeal mask. Recently, a single use version of the mask has been introduced. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Airway Management, Laryngeal Mask Airway, Fibreoptic Intubation
- What is being tested?
- Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™, Crossover Ambu Aura-i™ / LMA ETT™ and Crossover FASTRACH™ / Rüsch Super Safety Silk™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 12 Jul 2011to 7 Mar 2012
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergoing planned general anaesthesia
- planned tracheal intubation
- elective surgical procedure
- 15 to 80 years of age
Who cannot join
- ASA physical status IV and V
- severe pulmonary comorbidity (COPD GOLD >III, bronchial asthma)
- indication for rapid-sequence induction
- mouth opening (interincisor distance) <3cm
- morbid obesity (BMI >35kg.m-2)
About this study
The intubating laryngeal mask Fastrach™ is considered a gold standard for blind intubation as well as for fibreoptic guided intubation via a laryngeal mask. Recently, a single use version of the mask has been introduced. The Fastrach single use laryngeal mask is beng compared to the new, low-priced single use intubating laryngeal mask Ambu Aura-i™.
Read the detailed description
Eighty patients undergoing general anaesthesia with planned tracheal intubation for elective surgical procedures are enrolled in the study after checking for inclusion and exclusion criteria. Patients are randomised to either LMA group for blind tracheal intubation with either a standard PVC tracheal tube, or a specifically for the LMA Fastrach developed tube, yielding 4 subgroups.
After a standardised anaesthesia induction, blind intubation is performed in each study group. Different time intervals are documented, such as time to first adequate lung ventilation, or f.e. time for laryngeal mask placement. A crossover-design is performed after unsuccessful intubation, using the alternate LMA or the other tracheal tube. LMA placement is visualised by fibreoptic control.
An estimated success rate for blind intubation of 60% in the Aura-i group versus 90% in the Fastrach group yields a sample size of n= 38. To compensate for dropouts, n=40 subjects are enrolled in each group.
- Being tested
- Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™, Crossover Ambu Aura-i™ / LMA ETT™, Crossover FASTRACH™ / Rüsch Super Safety Silk™, Crossover FASTRACH™ / LMA ETT™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™Device
After unsuccessful blind intubation in the Ambu Aura-i™ / Rüsch Super Safety Silk™ group: crossover design using the Ambu Aura-i™ mask in combination with the LMA ETT™ tracheal tube
Crossover Ambu Aura-i™ / LMA ETT™Device
After unsuccessful blind intubation in the Ambu Aura-i™ / LMA ETT group: crossover design using the Ambu Aura-i™ mask in combination with the Rüsch Super Safety Silk™ tracheal tube
Crossover FASTRACH™ / Rüsch Super Safety Silk™Device
After unsuccessful blind intubation in the FASTRACH™ / Rüsch Super Safety Silk™ group: crossover design using the FASTRACH™ mask in combination with the LMA ETT™ tube
Crossover FASTRACH™ / LMA ETT™Device
After unsuccessful blind intubation in the FASTRACH™ / LMA ETT™ group: crossover design using the FASTRACH™ mask in combination with the Rüsch Super Safety Silk™ tube
| Study group | Role | What they receive |
|---|---|---|
| Aura-i / Rüsch | Experimental | Blind tracheal intubation: Combination of laryngeal mask Ambu Aura-i™ with Rüsch Super Safety Silk™ tracheal tube Receives: Device: Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™ |
| Aura-i / LMA ETT | Experimental | Blind tracheal intubation: Combination of laryngeal mask Ambu Aura-i™ with LMA ETT™ tracheal tube Receives: Device: Crossover Ambu Aura-i™ / LMA ETT™ |
| Fastrach / Rüsch | Experimental | Blind tracheal intubation: Combination of laryngeal mask Fastrach™ with Rüsch Super Safety Silk™ tracheal tube Receives: Device: Crossover FASTRACH™ / Rüsch Super Safety Silk™ |
| Fastrach / LMA ETT | Experimental | Blind tracheal intubation: Combination of laryngeal mask Fastrach™ with LMA ETT™ tracheal tube Receives: Device: Crossover FASTRACH™ / LMA ETT™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of blind intubation
overall success rate of blind tracheal intubation within two attempts using either the FASTRACH™ laryngeal mask or the Ambu Aura-i™ laryngeal mask
Measured: through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds
Secondary outcomes (5)
influence of tracheal tubes
influence of success rates of blind tracheal intubation using different tracheal tubes (Rüsch or LMA-ETT)
Measured: through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds
equivalence of the laryngeal masks regarding fibreoptic visualisation
fibreoptic control of laryngeal mask placement (Fastrach and Aura-i); the position of the larynx relative to the laryngeal cuff and mask-aperture is visualised and categorised as "correct", "lateral deviation", "epiglottic downfolding" or "not assessable"; additionally, the view on the larynx comparable to Cormack/Lehane score is recorded
Measured: through study completion; after placing the laryngeal mask and checking for airway leak pressure, fibreoptic visualisation is performed within 60 seconds
subjective handling score
subjective handling score for the two compared laryngeal masks, rated as excellent (1) - poor (4)
Measured: through study completion; the handling of the laryngeal masks during the first placement attempt within 60 seconds; directly after placing laryngeal masks and before fibreoptic visualisation, the subjective handling score is documented as above
differences in airway leak pressure
differences in airway leak pressure (ALP) of the two compared laryngeal masks, in cm H2O; presence of audible leakage as well as the absence of corresponding pressure increase on the monitor recorded by setting the APL valve to 40cm H2O, and fresh gas flow at 3l/min
Measured: through study completion; right after placing the laryngeal mask and checking for correct positioning, ALP is documented within 60 seconds
incidence of postoperative sore throat and hoarseness
incidence of postoperative sore throat and hoarseness as well as difficulty swallowing as reported by the study patients ("none", "moderate", "severe")
Measured: patient interview 24 hours post procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start12 Jul 2011
- Primary completion7 Mar 2012
- Study completion7 Mar 2012
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 Airway ManagementStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepios Kliniken Hamburg GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kiel
- Responsible party
- Principal investigator, Dr. Robert Schiewe, Asklepios Kliniken Hamburg GmbH
- Investigators
- Berthold Bein, Prof. Dr., Study chair, Asklepios Kliniken Hamburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109678
- Sponsor's protocol ID
- AZ 107/02
- Status last verified
- Apr 2017
- First submitted
- 8 Mar 2017
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schiewe R, Stoeck M, Gruenewald M, Hoecker J, Bein B. A comparison of blind intubation with the intubating laryngeal mask FASTRACH and the intubating laryngeal mask Ambu Aura-i a prospective randomised clinical trial. BMC Anesthesiol. 2019 Mar 30;19(1):44. doi: 10.1186/s12871-019-0718-6.
PubMed 30927922
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Intubating Laryngeal Mask FASTRACH™ and the Intubating Laryngeal Mask Ambu Aura-i™
- ClinicalTrials.gov ID
- NCT03109678
- Acronym / sponsor ID
- AZ 107/02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Asklepios Kliniken Hamburg GmbHUniversity, hospital or other
- Collaborators
- University of Kiel
- Study start
- 12 Jul 2011 (actual)
- Primary completion
- 7 Mar 2012 (actual)
- Study completion
- 7 Mar 2012 (actual)
- First posted
- 12 Apr 2017 (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 intubating laryngeal mask Fastrach™ is considered a gold standard for blind intubation as well as for fibreoptic guided intubation via a laryngeal mask. Recently, a single use version of the mask has been introduced. The Fastrach single use laryngeal mask is beng compared to the new, low-priced single use intubating laryngeal mask Ambu Aura-i™.
Detailed description
Eighty patients undergoing general anaesthesia with planned tracheal intubation for elective surgical procedures are enrolled in the study after checking for inclusion and exclusion criteria. Patients are randomised to either LMA group for blind tracheal intubation with either a standard PVC tracheal tube, or a specifically for the LMA Fastrach developed tube, yielding 4 subgroups.
After a standardised anaesthesia induction, blind intubation is performed in each study group. Different time intervals are documented, such as time to first adequate lung ventilation, or f.e. time for laryngeal mask placement. A crossover-design is performed after unsuccessful intubation, using the alternate LMA or the other tracheal tube. LMA placement is visualised by fibreoptic control.
An estimated success rate for blind intubation of 60% in the Aura-i group versus 90% in the Fastrach group yields a sample size of n= 38. To compensate for dropouts, n=40 subjects are enrolled in each group.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aura-i / Rüsch | Experimental | Device: Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™Blind tracheal intubation: Combination of laryngeal mask Ambu Aura-i™ with Rüsch Super Safety Silk™ tracheal tube |
| Aura-i / LMA ETT | Experimental | Device: Crossover Ambu Aura-i™ / LMA ETT™Blind tracheal intubation: Combination of laryngeal mask Ambu Aura-i™ with LMA ETT™ tracheal tube |
| Fastrach / Rüsch | Experimental | Device: Crossover FASTRACH™ / Rüsch Super Safety Silk™Blind tracheal intubation: Combination of laryngeal mask Fastrach™ with Rüsch Super Safety Silk™ tracheal tube |
| Fastrach / LMA ETT | Experimental | Device: Crossover FASTRACH™ / LMA ETT™Blind tracheal intubation: Combination of laryngeal mask Fastrach™ with LMA ETT™ tracheal tube |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing planned general anaesthesia
- planned tracheal intubation
- elective surgical procedure
- 15 to 80 years of age
Key exclusion criteria (5 listed)
- ASA physical status IV and V
- severe pulmonary comorbidity (COPD GOLD >III, bronchial asthma)
- indication for rapid-sequence induction
- mouth opening (interincisor distance) <3cm
- morbid obesity (BMI >35kg.m-2)
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 |
|---|---|---|
| Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™After unsuccessful blind intubation in the Ambu Aura-i™ / Rüsch Super Safety Silk™ group: crossover design using the Ambu Aura-i™ mask in combination with the LMA ETT™ tracheal tube | Device | Aura-i / Rüsch |
| Crossover Ambu Aura-i™ / LMA ETT™After unsuccessful blind intubation in the Ambu Aura-i™ / LMA ETT group: crossover design using the Ambu Aura-i™ mask in combination with the Rüsch Super Safety Silk™ tracheal tube | Device | Aura-i / LMA ETT |
| Crossover FASTRACH™ / Rüsch Super Safety Silk™After unsuccessful blind intubation in the FASTRACH™ / Rüsch Super Safety Silk™ group: crossover design using the FASTRACH™ mask in combination with the LMA ETT™ tube | Device | Fastrach / Rüsch |
| Crossover FASTRACH™ / LMA ETT™After unsuccessful blind intubation in the FASTRACH™ / LMA ETT™ group: crossover design using the FASTRACH™ mask in combination with the Rüsch Super Safety Silk™ tube | Device | Fastrach / LMA ETT |
Primary outcome
success rate of blind intubation
Time frame: through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds
overall success rate of blind tracheal intubation within two attempts using either the FASTRACH™ laryngeal mask or the Ambu Aura-i™ laryngeal mask
5 secondary outcomes
influence of tracheal tubes
Time frame: through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 seconds
equivalence of the laryngeal masks regarding fibreoptic visualisation
Time frame: through study completion; after placing the laryngeal mask and checking for airway leak pressure, fibreoptic visualisation is performed within 60 seconds
subjective handling score
Time frame: through study completion; the handling of the laryngeal masks during the first placement attempt within 60 seconds; directly after placing laryngeal masks and before fibreoptic visualisation, the subjective handling score is documented as above
differences in airway leak pressure
Time frame: through study completion; right after placing the laryngeal mask and checking for correct positioning, ALP is documented within 60 seconds
incidence of postoperative sore throat and hoarseness
Time frame: patient interview 24 hours post procedural
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 12 Apr 2017.
- Derived from this study: PubMed 30927922Schiewe R, Stoeck M, Gruenewald M, Hoecker J, Bein B. A comparison of blind intubation with the intubating laryngeal mask FASTRACH and the intubating laryngeal mask Ambu Aura-i a prospective randomised clinical trial. BMC Anesthesiol. 2019 Mar 30;19(1):44. doi: 10.1186/s12871-019-0718-6.
- Individual participant dataSharing planned: No
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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.
Berthold Bein, Prof. Dr. study chair
Asklepios Kliniken Hamburg GmbH
Questions about this trial
What is this clinical trial studying?
A study testing Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™, Crossover Ambu Aura-i™ / LMA ETT™ and Crossover FASTRACH™ / Rüsch Super Safety Silk™ in people with Airway Management and Laryngeal Mask Airway, run by Asklepios Kliniken Hamburg GmbH.
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 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 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
success rate of blind intubation (time frame: through study completion; time frame for individual study patient: two attempts of blind tracheal intubation peri-interventional, time maximum of 300 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 NCT03109678, 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 12 Apr 2017.