Adverse Anesthesia OutcomeNCT02570269
Prospective Comparison of Oral Intubation Via - Ambu® Aura Gain™ vs Slotted Guedel Tubus
A study testing AuraGain and Slotted Guedeltubus in people with Adverse Anesthesia Outcome, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
The study has to show that an intubation with the AuraGain Laryngeal mask could bring the same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adverse Anesthesia Outcome
- What is being tested?
- AuraGain and Slotted Guedeltubus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2015to Mar 2016
- 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
- Aged ≥18
- ASA 1 -2
- Surgery of the shoulder, elbow, hand, hip, knee or foot
- Signed consent form
Who cannot join
- Patients with expected difficulties regarding to the intubation
- Patients with diseases / anatomical changes in the area of the pharynx, the larynx, the trachea, the esophagus or the stomach
- Not sober
- Increased risk of aspiration
- BMI > 35 kg/m2
- Acute disease which could affect the suitability of the anesthesia
Show all 10Show fewer
- Patients in which the use of a laryngeal mask is contraindicated or otherwise not possible
- Patients with a disease which prevents an accurate examination of the patients (eg neuromuscular, mentally, metabolic disease)
- Drug abuse in the recent past
- Legal incompetence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Comparison Between a Flexible Fiberoptic Intubation Via the Ambu® Aura Gain™ Airway and the Slotted Guedel Tubus in Terms of Time to a Completed Airway Management and Patient Safety.
The study has to show that an intubation with the AuraGain Laryngeal mask could bring the same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.
- Conditions
- Adverse Anesthesia Outcome
- Being tested
- AuraGain, Slotted Guedeltubus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuraGainProcedure or surgery
Fiberoptic Intubation
Slotted GuedeltubusProcedure or surgery
Fiberoptic Intubation
| Study group | Role | What they receive |
|---|---|---|
| AuraGain | Active comparator | The patient will get a fiberoptic Intubation via the AuraGain larynxmask Receives: Procedure: AuraGain |
| Slotted Guedeltubus | Placebo comparator | The patient will get a fiberoptic intubation via the slotted Guedeltubus Receives: Procedure: Slotted Guedeltubus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Time to complete the Intubation in seconds
Measured: Intraoperative
Secondary outcomes (6)
Intubation attempts
The number of intubation attempts will be recorded (eg 1, 2, 3...)
Measured: Intraoperative
Esophagal Intubation attempts
The number of esophagal intubation attempts will be recorded (eg 1, 2, 3...)
Measured: Intraoperative
Resistance measurement of the Insertion as assessed by a four point scoring system
1/2/3/4
Measured: Intraoperative
Position of the mask as assessed by the Brimacombe Score
4/3/2/1
Measured: Intraoperative
Pain after Intubation as assessed by a Numeric Rating Scale
mild/moderate/severe
Measured: Intraoperative/2h postoperative/24h postoperative
AE/Complications
Occuring AE/Complications will be recorded
Measured: Intraoperative/postoperative until 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completionMar 2016
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 Adverse Anesthesia OutcomeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Moser, Schulthess Klinik
- Investigators
- Berthold Moser, MD, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570269
- Sponsor's protocol ID
- Schulthess_Anä_6
- Status last verified
- Apr 2016
- First submitted
- 23 Sep 2015
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Moser B, Audige L, Keller C, Brimacombe J, Gasteiger L, Bruppacher HR. Flexible bronchoscopic intubation through the AuraGain laryngeal mask versus a slit Guedel tube: a non-inferiority randomized-controlled trial. Can J Anaesth. 2017 Nov;64(11):1119-1128. doi: 10.1007/s12630-017-0936-7. Epub 2017 Jul 17.
PubMed 28718101
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison Between a Flexible Fiberoptic Intubation Via the Ambu® Aura Gain™ Airway and the Slotted Guedel Tubus in Terms of Time to a Completed Airway Management and Patient Safety.
- ClinicalTrials.gov ID
- NCT02570269
- Acronym / sponsor ID
- Schulthess_Anä_6
- Conditions
- Adverse Anesthesia Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Oct 2015 (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 has to show that an intubation with the AuraGain Laryngeal mask could bring the same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AuraGain | Active comparator | Procedure: AuraGainThe patient will get a fiberoptic Intubation via the AuraGain larynxmask |
| Slotted Guedeltubus | Placebo comparator | Procedure: Slotted GuedeltubusThe patient will get a fiberoptic intubation via the slotted Guedeltubus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥18
- ASA 1 -2
- Surgery of the shoulder, elbow, hand, hip, knee or foot
- Signed consent form
Key exclusion criteria (10 listed)
- Patients with expected difficulties regarding to the intubation
- Patients with diseases / anatomical changes in the area of the pharynx, the larynx, the trachea, the esophagus or the stomach
- Not sober
- Increased risk of aspiration
- BMI > 35 kg/m2
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 |
|---|---|---|
| AuraGainFiberoptic Intubation | Procedure or surgery | AuraGain |
| Slotted GuedeltubusFiberoptic Intubation | Procedure or surgery | Slotted Guedeltubus |
Primary outcome
Intubation time
Time frame: Intraoperative
Time to complete the Intubation in seconds
6 secondary outcomes
Intubation attempts
Time frame: Intraoperative
Esophagal Intubation attempts
Time frame: Intraoperative
Resistance measurement of the Insertion as assessed by a four point scoring system
Time frame: Intraoperative
Position of the mask as assessed by the Brimacombe Score
Time frame: Intraoperative
Pain after Intubation as assessed by a Numeric Rating Scale
Time frame: Intraoperative/2h postoperative/24h postoperative
AE/Complications
Time frame: Intraoperative/postoperative until 24h
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 Apr 2019.
- Derived from this study: PubMed 28718101Moser B, Audige L, Keller C, Brimacombe J, Gasteiger L, Bruppacher HR. Flexible bronchoscopic intubation through the AuraGain laryngeal mask versus a slit Guedel tube: a non-inferiority randomized-controlled trial. Can J Anaesth. 2017 Nov;64(11):1119-1128. doi: 10.1007/s12630-017-0936-7. Epub 2017 Jul 17.
Related trials for Adverse Anesthesia Outcome
RecruitingPhase 4
Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery
Analgesics, Opioid, Anesthesia, Spinal
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 Moser, MD principal investigator
Schulthess Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AuraGain and Slotted Guedeltubus in people with Adverse Anesthesia Outcome, run by Schulthess Klinik 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 10 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 Apr 2019. 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. Some participants in this study may receive a placebo. 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?
Intubation time (time frame: Intraoperative). 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 NCT02570269, 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 Apr 2019.