General AnesthesiaNCT01007370
Comparison of LMA-Fastrach and I-gel for Blind Tracheal Intubation.
A study testing Tracheal intubation in people with General Anesthesia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The investigators aim to compare two different types of supraglottic devices for tracheal intubation in patients undergoing elective surgery under general anesthesia. Our hypothesis is that the use of the I-gel supraglottic airway will result in a higher first attempt success rate of blind tracheal intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Tracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- ASA physical status 1-3
- Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation
Who cannot join
- ASA physical status 4-5
- Contraindications to muscle relaxation
- Anticipated or known difficult intubation or ventilation
- Patients with limited mouth opening (less than 2 cm)
- Patients at increased risk of aspiration, or having an history of symptomatic gastroesophageal reflux or hiatal hernia.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1
About this study
The investigators aim to compare two different types of supraglottic devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.
Our hypothesis is that the use of the I-gel supraglottic airway will result in a higher first attempt success rate of blind tracheal intubation.
Read the detailed description
Supraglottic airway devices such as LMA-Fastrach and I-gel provide patent airways during general anesthesia.
The LMA-Fastrach is designed to provide a conduit for blind or fiberoptically guided tracheal intubations. However, the success rate of tracheal intubation on the first attempt through this device varies between 50 and 87%.
The I-gel is a newer device for airway management which, with its wide bore, allows direct passage of a tracheal tube. Recent studies suggest that the I-gel is easy to insert and that limited experience is needed before a high success insertion rate is obtained.
In this prospective and randomized study, we will evaluate the performance of both devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.
- Conditions
- General Anesthesia
- Being tested
- Tracheal intubation
- Keywords
- tracheal intubation, supraglottic airway devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal intubationProcedure or surgery
Tracheal intubation through a supraglottic airway device(LMA-Fastrach).
Tracheal intubationProcedure or surgery
Tracheal intubation through a supraglottic airway device(I-gel).
| Study group | Role | What they receive |
|---|---|---|
| LMA-Fastrach | Active comparator | * Induction of general anesthesia with 1,5-2,5 mg/kg propofol and 1-3 mcg/kg fentanyl and neuromuscular relaxation with 0,6 mg/kg of rocuronium.
* Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification
* Insertion of LMA-Fastrach (sizes 3,4 or 5), establishment of ventilation
* Evaluation of glottic view through LMA-Fastrach using fibrescope (one out of ten patients)
* Tracheal intubation through the LMA-Fastrach
* With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device Receives: Procedure: Tracheal intubation |
| I-gel | Active comparator | * Induction of general anesthesia with 1,5-2,5 mg/kg propofol and 1-3 mcg/kg fentanyl and neuromuscular relaxation with 0,6 mg/kg of rocuronium.
* Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification
* Insertion of I-gel (sizes 3,4 or 5), establishment of ventilation
* Evaluation of glottic view through I-gel using fibrescope (one out of ten patients)
* Tracheal intubation through the I-gel
* With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device Receives: Procedure: Tracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate of tracheal intubation.
Measured: After successful insertion of tracheal tube
Secondary outcomes (4)
Time needed for successful insertion of a supraglottic device.
Measured: After insertion
First and total attempt success rate of supraglottic device insertion.
Measured: After insertion
Total time and number of attempts needed to obtain successful tracheal intubation.
Measured: After tracheal intubation
Fiberoptic view following the supraglottic device insertion.
Measured: After insertion of the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionMay 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 General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Massicotte, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007370
- Sponsor's protocol ID
- NM 2010-001
- Status last verified
- Aug 2017
- First submitted
- 3 Nov 2009
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of LMA-Fastrach and I-gel for Blind Tracheal Intubation.
- ClinicalTrials.gov ID
- NCT01007370
- Acronym / sponsor ID
- NM 2010-001
- Conditions
- General Anesthesia
- Keywords
- tracheal intubation, supraglottic airway devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Mar 2010 (actual)
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 4 Nov 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.
The investigators aim to compare two different types of supraglottic devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.
Our hypothesis is that the use of the I-gel supraglottic airway will result in a higher first attempt success rate of blind tracheal intubation.
Detailed description
Supraglottic airway devices such as LMA-Fastrach and I-gel provide patent airways during general anesthesia.
The LMA-Fastrach is designed to provide a conduit for blind or fiberoptically guided tracheal intubations. However, the success rate of tracheal intubation on the first attempt through this device varies between 50 and 87%.
The I-gel is a newer device for airway management which, with its wide bore, allows direct passage of a tracheal tube. Recent studies suggest that the I-gel is easy to insert and that limited experience is needed before a high success insertion rate is obtained.
In this prospective and randomized study, we will evaluate the performance of both devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA-Fastrach | Active comparator | Procedure: Tracheal intubation* Induction of general anesthesia with 1,5-2,5 mg/kg propofol and 1-3 mcg/kg fentanyl and neuromuscular relaxation with 0,6 mg/kg of rocuronium. * Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification * Insertion of LMA-Fastrach (sizes 3,4 or 5), establishment of ventilation * Evaluation of glottic view through LMA-Fastrach using fibrescope (one out of ten patients) * Tracheal intubation through the LMA-Fastrach * With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device |
| I-gel | Active comparator | Procedure: Tracheal intubation* Induction of general anesthesia with 1,5-2,5 mg/kg propofol and 1-3 mcg/kg fentanyl and neuromuscular relaxation with 0,6 mg/kg of rocuronium. * Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification * Insertion of I-gel (sizes 3,4 or 5), establishment of ventilation * Evaluation of glottic view through I-gel using fibrescope (one out of ten patients) * Tracheal intubation through the I-gel * With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and older
- ASA physical status 1-3
- Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation
Key exclusion criteria (5 listed)
- ASA physical status 4-5
- Contraindications to muscle relaxation
- Anticipated or known difficult intubation or ventilation
- Patients with limited mouth opening (less than 2 cm)
- Patients at increased risk of aspiration, or having an history of symptomatic gastroesophageal reflux or hiatal hernia.
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 |
|---|---|---|
| Tracheal intubationTracheal intubation through a supraglottic airway device(LMA-Fastrach). | Procedure or surgery | LMA-Fastrach |
| Tracheal intubationTracheal intubation through a supraglottic airway device(I-gel). | Procedure or surgery | I-gel |
Primary outcome
First attempt success rate of tracheal intubation.
Time frame: After successful insertion of tracheal tube
4 secondary outcomes
Time needed for successful insertion of a supraglottic device.
Time frame: After insertion
First and total attempt success rate of supraglottic device insertion.
Time frame: After insertion
Total time and number of attempts needed to obtain successful tracheal intubation.
Time frame: After tracheal intubation
Fiberoptic view following the supraglottic device insertion.
Time frame: After insertion of the device
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 3 Aug 2017.
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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.
Nathalie Massicotte, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheal intubation in people with General Anesthesia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 3 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 3 Aug 2017. 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 Canada. 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?
First attempt success rate of tracheal intubation. (time frame: After successful insertion of tracheal tube). 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 3 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.