IntubationNCT01265862
Does the Use of the GlideRite® Endotracheal Tube in Combination With the I-gel® Improve Intubation Success Rate?
A study testing Tracheal intubation through LMA-Fastrach® and Tracheal intubation through I-gel® in people with Intubation and 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. The investigators hypothesis is that the use of the I-gel® supraglottic airway device associated with a GlideRite® endotracheal tube will result in an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, General Anesthesia
- What is being tested?
- Tracheal intubation through LMA-Fastrach® and Tracheal intubation through I-gel®
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation
Who cannot join
- American Society of Anesthesiologists (ASA) classification ≥ 4
- Contraindications to muscle relaxation
- Mouth opening less than 2 cm
- Patients at increased risk of regurgitation
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
About this study
Official title: Comparison of LMA-Fastrach® and I-gel® for Tracheal Intubation: Does the Use of the GlideRite® Endotracheal Tube in Combination With the I-gel® Improve Success Rate?
The investigators aim to compare two different types of supraglottic devices for tracheal intubation in patients undergoing elective surgery under general anesthesia.
The investigators hypothesis is that the use of the I-gel® supraglottic airway device associated with a GlideRite® endotracheal tube will result in an equal success rate of fiberoptic tracheal intubation when compared to the LMA-Fastrach® associated with a GlideRite® endotracheal tube. Time to intubate with the I-gel® device should also be shorter.
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 fiberscopically 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. A recent study conducted in our center compared the LMA-Fastrach® to the I-gel® supraglottic airway device. Our results showed a lower success intubation rate in the I-gel® group. We noticed that there was a tendency for the endotracheal tube to impinge on the posterior and lateral aspect of the larynx. The endotracheal tube used for intubation in our study was a standard polyvinyl chloride (PVC) tube. We believe that an endotracheal tube with a flexible tip(GlideRite®) would increase the intubation success rate through the I-gel® device. However, based on our clinical experience with the GlideRite® tube, blind tracheal intubation through the I-gel® airway device may be associated with a low success rate related to a lack of rigidity of its tip. Its use in combination with a fibrescope could compensate for this weakness. A recent study performed on mannequins showed a comparable success intubation rate of 99% for the I-gel® and LMA-Fastrach® when associated to a fibrescope.
In this prospective randomized study, we will compare the performance of the LMA-Fastrach® and the I-gel® associated with a GlideRite® endotracheal tube for fiberoptic tracheal intubation in patients undergoing elective surgery under general anesthesia.
- Conditions
- Intubation, General Anesthesia
- Being tested
- Tracheal intubation through LMA-Fastrach®, Tracheal intubation through I-gel®
- Keywords
- Tracheal intubation, Supraglottic airway devices, Patients undergoing general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal intubation through LMA-Fastrach®Procedure or surgery
Tracheal intubation through a supraglottic airway device (LMA-Fastrach®) using a GlideRite® endotracheal tube
Tracheal intubation through I-gel®Procedure or surgery
Tracheal intubation through a supraglottic airway device (I-gel®) using a GlideRite® endotracheal tube
| Study group | Role | What they receive |
|---|---|---|
| LMA-Fastrach® and GlideRite® tube | 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®, establishment of ventilation
* Evaluation of glottic view through LMA-Fastrach® using fibrescope
* Tracheal intubation with the GlideRite® tube through the LMA-Fastrach®
* With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device Receives: Procedure: Tracheal intubation through LMA-Fastrach® |
| I-gel® and GlideRite® tube | Experimental | * 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®, establishment of ventilation
* Evaluation of glottic view through I-gel® using fibrescope
* Tracheal intubation with the GlideRite® endotracheal tube through the I-gel®
* With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device Receives: Procedure: Tracheal intubation through I-gel® |
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 before the beginning of surgery
Secondary outcomes (5)
Time needed for successful insertion of a supraglottic device
Measured: After insertion of the device before the beginning of surgery
Time needed to obtain successful tracheal intubation
Measured: After tracheal intubation before the beginning of surgery
First attempt success rate of supraglottic device insertion
Measured: After insertion of the device before the beginning of surgery
Global success rate of supraglottic device insertion
Measured: After insertion of the device before the beginning of surgery
Fibreoptic view following the supraglottic device insertion
Measured: After insertion of the device before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startApr 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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
- 120 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
- NCT01265862
- Sponsor's protocol ID
- NM2011-001
- Status last verified
- Aug 2012
- First submitted
- 21 Dec 2010
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of LMA-Fastrach® and I-gel® for Tracheal Intubation: Does the Use of the GlideRite® Endotracheal Tube in Combination With the I-gel® Improve Success Rate?
- ClinicalTrials.gov ID
- NCT01265862
- Acronym / sponsor ID
- NM2011-001
- Conditions
- Intubation, General Anesthesia
- Keywords
- Tracheal intubation, Supraglottic airway devices, Patients undergoing general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Apr 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Dec 2010 (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.
The investigators hypothesis is that the use of the I-gel® supraglottic airway device associated with a GlideRite® endotracheal tube will result in an equal success rate of fiberoptic tracheal intubation when compared to the LMA-Fastrach® associated with a GlideRite® endotracheal tube. Time to intubate with the I-gel® device should also be shorter.
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 fiberscopically 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. A recent study conducted in our center compared the LMA-Fastrach® to the I-gel® supraglottic airway device. Our results showed a lower success intubation rate in the I-gel® group. We noticed that there was a tendency for the endotracheal tube to impinge on the posterior and lateral aspect of the larynx. The endotracheal tube used for intubation in our study was a standard polyvinyl chloride (PVC) tube. We believe that an endotracheal tube with a flexible tip(GlideRite®) would increase the intubation success rate through the I-gel® device. However, based on our clinical experience with the GlideRite® tube, blind tracheal intubation through the I-gel® airway device may be associated with a low success rate related to a lack of rigidity of its tip. Its use in combination with a fibrescope could compensate for this weakness. A recent study performed on mannequins showed a comparable success intubation rate of 99% for the I-gel® and LMA-Fastrach® when associated to a fibrescope.
In this prospective randomized study, we will compare the performance of the LMA-Fastrach® and the I-gel® associated with a GlideRite® endotracheal tube for fiberoptic 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® and GlideRite® tube | Active comparator | Procedure: Tracheal intubation through LMA-Fastrach®* 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®, establishment of ventilation * Evaluation of glottic view through LMA-Fastrach® using fibrescope * Tracheal intubation with the GlideRite® tube through the LMA-Fastrach® * With the endotracheal tube in place, the anaesthesiologist will proceed to the removal of supraglottic device |
| I-gel® and GlideRite® tube | Experimental | Procedure: Tracheal intubation through I-gel®* 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®, establishment of ventilation * Evaluation of glottic view through I-gel® using fibrescope * Tracheal intubation with the GlideRite® endotracheal tube 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 (2 listed)
- Age 18 and older
- Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation
Key exclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) classification ≥ 4
- Contraindications to muscle relaxation
- Mouth opening less than 2 cm
- Patients at increased risk of regurgitation
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 intubation through LMA-Fastrach®Tracheal intubation through a supraglottic airway device (LMA-Fastrach®) using a GlideRite® endotracheal tube | Procedure or surgery | LMA-Fastrach® and GlideRite® tube |
| Tracheal intubation through I-gel®Tracheal intubation through a supraglottic airway device (I-gel®) using a GlideRite® endotracheal tube | Procedure or surgery | I-gel® and GlideRite® tube |
Primary outcome
First attempt success rate of tracheal intubation
Time frame: After successful insertion of tracheal tube before the beginning of surgery
5 secondary outcomes
Time needed for successful insertion of a supraglottic device
Time frame: After insertion of the device before the beginning of surgery
Time needed to obtain successful tracheal intubation
Time frame: After tracheal intubation before the beginning of surgery
First attempt success rate of supraglottic device insertion
Time frame: After insertion of the device before the beginning of surgery
Global success rate of supraglottic device insertion
Time frame: After insertion of the device before the beginning of surgery
Fibreoptic view following the supraglottic device insertion
Time frame: After insertion of the device before surgery
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 23 Aug 2012.
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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 through LMA-Fastrach® and Tracheal intubation through I-gel® in people with Intubation and 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 2 inclusion and 4 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 23 Aug 2012. 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 before the beginning of surgery). 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 23 Aug 2012.