IntubationNCT00983229
Comparison of CTrach, Intubating Laryngeal Mask Airway (ILMA) and I-gel for Tracheal Intubation
A study testing Tracheal intubation in people with Intubation, run by Northern Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
Various supraglottic airways may be used as a dedicated airway for insertion of intubating fibrescope and tracheal intubation in the patients with difficult to manage airways (Difficult Airway Society Guidelines). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Intubation
- What is being tested?
- Tracheal intubation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Sep 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III patients
- Age 18-89 years, males and females
- Elective surgical patients needing tracheal intubation
Who cannot join
- ASA IV or V patients
- Emergency surgical procedures
- Patients at increased risk of aspiration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Position of Supraglottic Airway as a Conduit for Tracheal Intubation - A Comparison of CTrach, Intubating LMA and I-gel Supraglottic Airway
Various supraglottic airways may be used as a dedicated airway for insertion of intubating fibrescope and tracheal intubation in the patients with difficult to manage airways (Difficult Airway Society Guidelines).
The investigators aim to compare three different types of supraglottic device as a conduit for tracheal intubation - CTrach optical laryngeal mask, Intubating laryngeal mask airway and I-gel supraglottic airway. Null hypothesis for this study is that all three devices will perform without statistical difference in the means of success rate and time needed for their insertion and tracheal intubation.
Read the detailed description
Supraglottic airway devices such as I-LMa, Igel and LMA Ctrach are designed to create a "dedicated" airway which safely allows both spontaneous and controlled ventilation. The use of supraglottic airways can allow planned fibreoptic intubations in expected difficult cases and can provide an emergency airway in cases of unexpected difficult airway.
The ILMA (Intavent Orthofix Ltd.,Wokingham, UK) has been designed for either blind or fibrescope-guided tracheal intubation, in patients with expected and unexpected difficult airway. Since its development in 1997, it has been used for both blind and fibrescope-guided tracheal intubations in the patients with difficult airway. The ILMA is currently a 'gold standard' in supraglottic airways used for tracheal intubation.
The I-gel (Intersurgical Ltd., Wokingham, UK) is a newer dedicated airway device, which with its wide bore allows direct passage of a tracheal tube.
The CTrach (The Laryngeal Mask Company,Singapore) is a newer device for airway management. It has special optical fibres built-in inside its bowl and a liquid crystal display which allows views of the larynx while the endotracheal tube is being placed.
With reference to these supraglottic airway devices, only a small number of case reports detail tracheal intubation through an I-gel in patients with difficult airways. There have been manikin studies comparing ILMA and CTrach, and some descriptive studies on the use of CTrach in patients with predicted difficult airways- but no studies comparing the performance of these devices in clinical practice.
- Conditions
- Intubation
- Being tested
- Tracheal intubation
- Keywords
- difficult airway, fibreoptic intubation, supraglottic airways, laryngeal mask airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal intubationProcedure or surgery
Also called intubation, insertion of tracheal tube
Insertion of a plastic tube under direct vision (built-in camera, intubating fibrescope) into trachea.
| Study group | Role | What they receive |
|---|---|---|
| CTrach | Active comparator | 1. Induction to GA with 1mcg/kg fentanyl, and 1-3 mg/kg of propofol to loss of verbal contact and neuromuscular relaxation with 0.5 mg/kg of atracurium.
2. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification.
3. Insertion of CTrach (sizes 3,4 or 5), establishment of ventilation.
4. Direct evaluation of laryngeal view through CTrach
5. Tracheal intubation through CTrach LMA
6. Maintenance of anaesthesia with 02, air and sevoflurane 1-2 MAC and positive pressure ventilation
7. At the end of surgery patient will be awoken as normal. Any sign of trauma to the oral cavity and airways and gastric fluid in trachea will be noted. Receives: Procedure: Tracheal intubation |
| Intubating Laryngeal Mask Airway (ILMA) | Active comparator | 1. Induction to GA with 1mcg/kg fentanyl, and 1-3 mg/kg of propofol to loss of verbal contact and neuromuscular relaxation with 0.5 mg/kg of atracurium.
2. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification.
3. Insertion of ILMA (sizes 3,4 or 5), establishment of ventilation.
4. Evaluation of laryngeal view through ILMA using fibrescope
5. Tracheal intubation through ILMA using fibrescope.
6. Maintenance of anaesthesia with 02, air and sevoflurane 1-2 MAC and positive pressure ventilation
7. At the end of surgery patient will be awoken as normal. Any sign of trauma to the oral cavity and airways and gastric fluid in trachea will be noted. Receives: Procedure: Tracheal intubation |
| I-gel | Active comparator | 1. Induction to GA with 1mcg/kg fentanyl, and 1-3 mg/kg of propofol to loss of verbal contact and neuromuscular relaxation with 0.5 mg/kg of atracurium.
2. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification.
3. Insertion of I-gel (sizes 3,4 or 5), establishment of ventilation.
4. Evaluation of laryngeal view through I-gel using fibrescope
5. Tracheal intubation through I-gel using fibrescope
6. Maintenance of anaesthesia with 02, air and sevoflurane 1-2 MAC and positive pressure ventilation
7. At the end of surgery patient will be awoken as normal. Any sign of trauma to the oral cavity and airways and gastric fluid in trachea will be noted. Receives: Procedure: Tracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Total time needed for successful tracheal intubation through a device
Measured: After insertion
Fibreoptic view following to supraglottic device insertion
Measured: After insertion of SGA
Complication rate - sore throat, difficulty swallowing, hoarseness, numb tongue, nausea
Measured: at 1 h after operation, at 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies 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, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Health and Social Care Trust
- Sponsor type
- Other government
- Investigators
- Pavel Michalek, MD,PhD,DESA, Principal investigator, Northern HSC Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983229
- Sponsor's protocol ID
- 09/NIR03/44
- Status last verified
- Oct 2010
- First submitted
- 23 Sep 2009
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Campbell J, Michalek P, Deighan M. I-gel supraglottic airway for rescue airway management and as a conduit for tracheal intubation in a patient with acute respiratory failure. Resuscitation. 2009 Aug;80(8):963. doi: 10.1016/j.resuscitation.2009.04.037. Epub 2009 Jun 10. No abstract available.
PubMed 19520483Michalek P, Hodgkinson P, Donaldson W. Fiberoptic intubation through an I-gel supraglottic airway in two patients with predicted difficult airway and intellectual disability. Anesth Analg. 2008 May;106(5):1501-4, table of contents. doi: 10.1213/ane.0b013e31816f22f6.
PubMed 18420867Sreevathsa S, Nathan PL, John B, Danha RF, Mendonca C. Comparison of fibreoptic-guided intubation through ILMA versus intubation through LMA-CTrach. Anaesthesia. 2008 Jul;63(7):734-7. doi: 10.1111/j.1365-2044.2008.05481.x.
PubMed 18582259Ferson DZ, Rosenblatt WH, Johansen MJ, Osborn I, Ovassapian A. Use of the intubating LMA-Fastrach in 254 patients with difficult-to-manage airways. Anesthesiology. 2001 Nov;95(5):1175-81. doi: 10.1097/00000542-200111000-00022.
PubMed 11684987Charters P, O'Sullivan E. The 'dedicated airway': a review of the concept and an update of current practice. Anaesthesia. 1999 Aug;54(8):778-86. doi: 10.1046/j.1365-2044.1999.00888.x.
PubMed 10460531Pandit JJ, MacLachlan K, Dravid RM, Popat MT. Comparison of times to achieve tracheal intubation with three techniques using the laryngeal or intubating laryngeal mask airway. Anaesthesia. 2002 Feb;57(2):128-32. doi: 10.1046/j.0003-2409.2001.02401.x.
PubMed 11871949Joo HS, Kapoor S, Rose DK, Naik VN. The intubating laryngeal mask airway after induction of general anesthesia versus awake fiberoptic intubation in patients with difficult airways. Anesth Analg. 2001 May;92(5):1342-6. doi: 10.1097/00000539-200105000-00050.
PubMed 11323374Ng BS, Goy RW, Bain JA, Chen FG, Liu EH. The impact of manual in-line stabilisation on ventilation and visualisation of the glottis with the LMA CTrach: a randomised crossover trial. Anaesthesia. 2009 Aug;64(8):894-8. doi: 10.1111/j.1365-2044.2009.05935.x.
PubMed 19604194Liu EH, Goy RW, Lim Y, Chen FG. Success of tracheal intubation with intubating laryngeal mask airways: a randomized trial of the LMA Fastrach and LMA CTrach. Anesthesiology. 2008 Apr;108(4):621-6. doi: 10.1097/ALN.0b013e318167af61.
PubMed 18362593Liu EH, Goy RW, Chen FG. An evaluation of poor LMA CTrach views with a fibreoptic laryngoscope and the effectiveness of corrective measures. Br J Anaesth. 2006 Dec;97(6):878-82. doi: 10.1093/bja/ael252. Epub 2006 Sep 19.
PubMed 16984953
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Position of Supraglottic Airway as a Conduit for Tracheal Intubation - A Comparison of CTrach, Intubating LMA and I-gel Supraglottic Airway
- ClinicalTrials.gov ID
- NCT00983229
- Acronym / sponsor ID
- 09/NIR03/44
- Conditions
- Intubation
- Keywords
- difficult airway, fibreoptic intubation, supraglottic airways, laryngeal mask airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Northern Health and Social Care TrustOther government
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Sep 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.
Various supraglottic airways may be used as a dedicated airway for insertion of intubating fibrescope and tracheal intubation in the patients with difficult to manage airways (Difficult Airway Society Guidelines).
The investigators aim to compare three different types of supraglottic device as a conduit for tracheal intubation - CTrach optical laryngeal mask, Intubating laryngeal mask airway and I-gel supraglottic airway. Null hypothesis for this study is that all three devices will perform without statistical difference in the means of success rate and time needed for their insertion and tracheal intubation.
Detailed description
Supraglottic airway devices such as I-LMa, Igel and LMA Ctrach are designed to create a "dedicated" airway which safely allows both spontaneous and controlled ventilation. The use of supraglottic airways can allow planned fibreoptic intubations in expected difficult cases and can provide an emergency airway in cases of unexpected difficult airway.
The ILMA (Intavent Orthofix Ltd.,Wokingham, UK) has been designed for either blind or fibrescope-guided tracheal intubation, in patients with expected and unexpected difficult airway. Since its development in 1997, it has been used for both blind and fibrescope-guided tracheal intubations in the patients with difficult airway. The ILMA is currently a 'gold standard' in supraglottic airways used for tracheal intubation.
The I-gel (Intersurgical Ltd., Wokingham, UK) is a newer dedicated airway device, which with its wide bore allows direct passage of a tracheal tube.
The CTrach (The Laryngeal Mask Company,Singapore) is a newer device for airway management. It has special optical fibres built-in inside its bowl and a liquid crystal display which allows views of the larynx while the endotracheal tube is being placed.
With reference to these supraglottic airway devices, only a small number of case reports detail tracheal intubation through an I-gel in patients with difficult airways. There have been manikin studies comparing ILMA and CTrach, and some descriptive studies on the use of CTrach in patients with predicted difficult airways- but no studies comparing the performance of these devices in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CTrach | Active comparator | Procedure: Tracheal intubation1. Induction to GA with 1mcg/kg fentanyl, and 1-3 mg/kg of propofol to loss of verbal contact and neuromuscular relaxation with 0.5 mg/kg of atracurium. 2. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification. 3. Insertion of CTrach (sizes 3,4 or 5), establishment of ventilation. 4. Direct evaluation of laryngeal view through CTrach 5. Tracheal intubation through CTrach LMA 6. Maintenance of anaesthesia with 02, air and sevoflurane 1-2 MAC and positive pressure ventilation 7. At the end of surgery patient will be awoken as normal. Any sign of trauma to the oral cavity and airways and gastric fluid in trachea will be noted. |
| Intubating Laryngeal Mask Airway (ILMA) | Active comparator | Procedure: Tracheal intubation1. Induction to GA with 1mcg/kg fentanyl, and 1-3 mg/kg of propofol to loss of verbal contact and neuromuscular relaxation with 0.5 mg/kg of atracurium. 2. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification. 3. Insertion of ILMA (sizes 3,4 or 5), establishment of ventilation. 4. Evaluation of laryngeal view through ILMA using fibrescope 5. Tracheal intubation through ILMA using fibrescope. 6. Maintenance of anaesthesia with 02, air and sevoflurane 1-2 MAC and positive pressure ventilation 7. At the end of surgery patient will be awoken as normal. Any sign of trauma to the oral cavity and airways and gastric fluid in trachea will be noted. |
| I-gel | Active comparator | Procedure: Tracheal intubation1. Induction to GA with 1mcg/kg fentanyl, and 1-3 mg/kg of propofol to loss of verbal contact and neuromuscular relaxation with 0.5 mg/kg of atracurium. 2. Direct laryngoscopy, evaluation of laryngeal view grade according to Cormack-Lehane classification. 3. Insertion of I-gel (sizes 3,4 or 5), establishment of ventilation. 4. Evaluation of laryngeal view through I-gel using fibrescope 5. Tracheal intubation through I-gel using fibrescope 6. Maintenance of anaesthesia with 02, air and sevoflurane 1-2 MAC and positive pressure ventilation 7. At the end of surgery patient will be awoken as normal. Any sign of trauma to the oral cavity and airways and gastric fluid in trachea will be noted. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III patients
- Age 18-89 years, males and females
- Elective surgical patients needing tracheal intubation
Key exclusion criteria (3 listed)
- ASA IV or V patients
- Emergency surgical procedures
- Patients at increased risk of aspiration
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 intubationAlso: intubation, insertion of tracheal tubeInsertion of a plastic tube under direct vision (built-in camera, intubating fibrescope) into trachea. | Procedure or surgery | CTrach, I-gel, Intubating Laryngeal Mask Airway (ILMA) |
Primary outcome
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
Total time needed for successful tracheal intubation through a device
Time frame: After insertion
Fibreoptic view following to supraglottic device insertion
Time frame: After insertion of SGA
Complication rate - sore throat, difficulty swallowing, hoarseness, numb tongue, nausea
Time frame: at 1 h after operation, at 24 h
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 15 Nov 2010.
- Background: PubMed 19520483Campbell J, Michalek P, Deighan M. I-gel supraglottic airway for rescue airway management and as a conduit for tracheal intubation in a patient with acute respiratory failure. Resuscitation. 2009 Aug;80(8):963. doi: 10.1016/j.resuscitation.2009.04.037. Epub 2009 Jun 10. No abstract available.
- Background: PubMed 18420867Michalek P, Hodgkinson P, Donaldson W. Fiberoptic intubation through an I-gel supraglottic airway in two patients with predicted difficult airway and intellectual disability. Anesth Analg. 2008 May;106(5):1501-4, table of contents. doi: 10.1213/ane.0b013e31816f22f6.
- Background: PubMed 18582259Sreevathsa S, Nathan PL, John B, Danha RF, Mendonca C. Comparison of fibreoptic-guided intubation through ILMA versus intubation through LMA-CTrach. Anaesthesia. 2008 Jul;63(7):734-7. doi: 10.1111/j.1365-2044.2008.05481.x.
- Background: PubMed 11684987Ferson DZ, Rosenblatt WH, Johansen MJ, Osborn I, Ovassapian A. Use of the intubating LMA-Fastrach in 254 patients with difficult-to-manage airways. Anesthesiology. 2001 Nov;95(5):1175-81. doi: 10.1097/00000542-200111000-00022.
- Background: PubMed 10460531Charters P, O'Sullivan E. The 'dedicated airway': a review of the concept and an update of current practice. Anaesthesia. 1999 Aug;54(8):778-86. doi: 10.1046/j.1365-2044.1999.00888.x.
- Background: PubMed 11871949Pandit JJ, MacLachlan K, Dravid RM, Popat MT. Comparison of times to achieve tracheal intubation with three techniques using the laryngeal or intubating laryngeal mask airway. Anaesthesia. 2002 Feb;57(2):128-32. doi: 10.1046/j.0003-2409.2001.02401.x.
- Background: PubMed 11323374Joo HS, Kapoor S, Rose DK, Naik VN. The intubating laryngeal mask airway after induction of general anesthesia versus awake fiberoptic intubation in patients with difficult airways. Anesth Analg. 2001 May;92(5):1342-6. doi: 10.1097/00000539-200105000-00050.
- Background: PubMed 19604194Ng BS, Goy RW, Bain JA, Chen FG, Liu EH. The impact of manual in-line stabilisation on ventilation and visualisation of the glottis with the LMA CTrach: a randomised crossover trial. Anaesthesia. 2009 Aug;64(8):894-8. doi: 10.1111/j.1365-2044.2009.05935.x.
- Background: PubMed 18362593Liu EH, Goy RW, Lim Y, Chen FG. Success of tracheal intubation with intubating laryngeal mask airways: a randomized trial of the LMA Fastrach and LMA CTrach. Anesthesiology. 2008 Apr;108(4):621-6. doi: 10.1097/ALN.0b013e318167af61.
- Background: PubMed 16984953Liu EH, Goy RW, Chen FG. An evaluation of poor LMA CTrach views with a fibreoptic laryngoscope and the effectiveness of corrective measures. Br J Anaesth. 2006 Dec;97(6):878-82. doi: 10.1093/bja/ael252. Epub 2006 Sep 19.
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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.
Pavel Michalek, MD,PhD,DESA principal investigator
Northern HSC Trust
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 Intubation, run by Northern Health and Social Care Trust at 1 site in United Kingdom.
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 3 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 15 Nov 2010. 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 United Kingdom. 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?
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?
On the ClinicalTrials.gov record for NCT00983229, which also lists 10 linked publications.
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 15 Nov 2010.