Tracheal IntubationNCT00888875
ILMA Fastrach Versus I-gel for Fiberoptic Tracheal Intubation
A study testing i-gel and ILMA in people with Tracheal Intubation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
We evaluate feasibility of fiberoptic intubation through the "ILMA Fastrach" vs the "i-gel". Both are airway devices to be introduced in the mouth we the possibility to ventilate the patient and furthermore to be a guide to introduce a tracheal tube. We first insert either the ILMA or the i-gel. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- i-gel and ILMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2008to May 2010
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective operation with intubation
- ASA I-IV
- speaks German
- at least one predictor for difficult intubation
Who cannot join
- weight <30kg
- Risk Aspiration
- Risk bleeding orally
- known or highly suspected difficult mask ventilation
- Mouth opening < 20mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Fiberoptic Intubation Through the I-gel™ Equal to Fiberoptic Intubation Through the Intubating Laryngeal Mask (Fastrach)™ ?
We evaluate feasibility of fiberoptic intubation through the "ILMA Fastrach" vs the "i-gel". Both are airway devices to be introduced in the mouth we the possibility to ventilate the patient and furthermore to be a guide to introduce a tracheal tube. We first insert either the ILMA or the i-gel. In a second step, we will introduce a tube through the device, all guided visually through a fiberoptic tool which works as a railroad for the tracheal tube.
Read the detailed description
The ILMA Fastrach™ is a widely accepted and intensively investigated supraglottic airway device that is inserted blindly. It may be used to facilitate intubation and secure the airway in routine practice, in difficult airway scenarios or in emergency situations. Endotracheal tube insertion may be blind or fiberoptic scope guided, the latter raises the success rate. The i-gel™ is a newly developed supraglottic airway device and is also introduced blindly. Insertion of an endotracheal tube may be blind or fiberoptically guided.
So far, prospective randomized controlled trials comparing their performance are not yet published. There are case reports about intubating over the i-gel.
In this prospective, randomized, controlled trial, we are going to evaluate the performance of intubation through both devices. In 250 patients undergoing elective surgery, we will place either the ILMA or the i-gel according to randomization and then intubate with the help of a fiberoptic scope, using the specific ILMA tracheal tube or a normal tracheal tube for the i-gel. In order to remove the supraglottic airway devices, we will use the ILMA stabilizer rod.
- Conditions
- Tracheal Intubation
- Being tested
- i-gel, ILMA
- Keywords
- i-gel, Fastrach, intubation, fiberoptic, difficult airway, Patients undergoing elective surgery requiring tracheal intubation, Presenting at least one sign of difficult intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-gelDevice
insertion after induction of anaesthesia. Afterwards, intubation over the device fiberoptically
ILMADevice
Insertion after Induction. Insertion of tracheal tube over device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Computer randomized insertion of the i-gel. Intubation fiberoptically of a tracheal tube Receives: Device: i-gel |
| 2 | Active comparator | Computer randomized insertion of the i-gel. Intubation fiberoptically of a tracheal tube Receives: Device: ILMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful intubation attempt with ventilation of both lungs
Measured: during intervention
Secondary outcomes (2)
insertion of supraglottic airway devices, the time to intubate, airway device leak pressure, adverse events and postoperative side effects
Measured: during intervention and first 24hours after operation
simulated blind intubation in both groups
Measured: during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startJul 2008
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Greif, M.D., Study director, Department of Anesthesia, University Hospital Berne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888875
- Sponsor's protocol ID
- Fast igel1
- Status last verified
- Mar 2014
- First submitted
- 27 Apr 2009
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Fiberoptic Intubation Through the I-gel™ Equal to Fiberoptic Intubation Through the Intubating Laryngeal Mask (Fastrach)™ ?
- ClinicalTrials.gov ID
- NCT00888875
- Acronym / sponsor ID
- Fast igel1
- Conditions
- Tracheal Intubation
- Keywords
- i-gel, Fastrach, intubation, fiberoptic, difficult airway, Patients undergoing elective surgery requiring tracheal intubation, Presenting at least one sign of difficult intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Apr 2009 (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.
We evaluate feasibility of fiberoptic intubation through the "ILMA Fastrach" vs the "i-gel". Both are airway devices to be introduced in the mouth we the possibility to ventilate the patient and furthermore to be a guide to introduce a tracheal tube. We first insert either the ILMA or the i-gel. In a second step, we will introduce a tube through the device, all guided visually through a fiberoptic tool which works as a railroad for the tracheal tube.
Detailed description
The ILMA Fastrach™ is a widely accepted and intensively investigated supraglottic airway device that is inserted blindly. It may be used to facilitate intubation and secure the airway in routine practice, in difficult airway scenarios or in emergency situations. Endotracheal tube insertion may be blind or fiberoptic scope guided, the latter raises the success rate. The i-gel™ is a newly developed supraglottic airway device and is also introduced blindly. Insertion of an endotracheal tube may be blind or fiberoptically guided.
So far, prospective randomized controlled trials comparing their performance are not yet published. There are case reports about intubating over the i-gel.
In this prospective, randomized, controlled trial, we are going to evaluate the performance of intubation through both devices. In 250 patients undergoing elective surgery, we will place either the ILMA or the i-gel according to randomization and then intubate with the help of a fiberoptic scope, using the specific ILMA tracheal tube or a normal tracheal tube for the i-gel. In order to remove the supraglottic airway devices, we will use the ILMA stabilizer rod.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: i-gelComputer randomized insertion of the i-gel. Intubation fiberoptically of a tracheal tube |
| 2 | Active comparator | Device: ILMAComputer randomized insertion of the i-gel. Intubation fiberoptically of a tracheal tube |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective operation with intubation
- ASA I-IV
- speaks German
- at least one predictor for difficult intubation
Key exclusion criteria (5 listed)
- weight <30kg
- Risk Aspiration
- Risk bleeding orally
- known or highly suspected difficult mask ventilation
- Mouth opening < 20mm
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 |
|---|---|---|
| i-gelinsertion after induction of anaesthesia. Afterwards, intubation over the device fiberoptically | Device | 1 |
| ILMAInsertion after Induction. Insertion of tracheal tube over device | Device | 2 |
Primary outcome
successful intubation attempt with ventilation of both lungs
Time frame: during intervention
2 secondary outcomes
insertion of supraglottic airway devices, the time to intubate, airway device leak pressure, adverse events and postoperative side effects
Time frame: during intervention and first 24hours after operation
simulated blind intubation in both groups
Time frame: during intervention
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 Mar 2014.
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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.
Robert Greif, M.D. study director
Department of Anesthesia, University Hospital Berne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-gel and ILMA in people with Tracheal Intubation, run by Insel Gruppe AG, University Hospital Bern 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 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 Mar 2014. 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?
successful intubation attempt with ventilation of both lungs (time frame: during intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2014.