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The study aims to establish which of the two second generation Supraglottic Airway Devices, the I-gel or the the laryngeal ask airway (LMA) Protector, is best suited to be used as a conduit to fibreoptic bronchoscope assisted tracheal intubation. The primary outcome of this will be the time to complete the tracheal intubation.
Tracheal intubation through a supraglottic airway device (SAD) is a well-established technique in the management of patients with a difficult airway. The technique can be used in patients in whom difficult intubation is expected, or in situations when tracheal intubation using another method was not possible. It is now recommended that tracheal intubation through the SAD should be performed using a fibreoptic scope (a camera device) to minimise the risk of trauma to the airway, and that second generation SADs are used to minimise the risk of aspiration of gastric contents.
There are two second generation SADs currently available which allow tracheal intubation: the I-gel and the LMA protector.
The I-gel is a second generation supraglottic airway device widely used in anaesthesia and resuscitation. Fibreoptic intubation through the I-gel has been evaluated in a recent prospective study (1), with the first attempt success rate of 91.4%. In another study (2) of patients with predicted difficult airway, the success rate of the procedure at first attempt was 96%.
LMA Protector is a recently introduced, improved version the LMA supreme - another second generation SAD. LMA supreme has been used in clinical practice for more than 10 years, however, tracheal intubation through the device was extremely difficult because of the small size of the breathing channel. The LMA Protector, has a larger breathing channel allowing the passage of an endotracheal tube. Compared to the I-gel, is has also got a larger gastric drainage tube. This allows easy suction in the event of regurgitation. Therefore, it appears to be superior to the I-gel in preventing the aspiration. But there are no studies comparing the ease of intubation through I-gel and LMA Protector
The aim of this study is to compare the ease of performing the fibreoptic guided tracheal intubation through these two devices. Our hypothesis is that intubation through the I-gel is easier and quicker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-gel | Active Comparator | Fibreoptic guided tracheal intubation through I-gel |
|
| LMA Protector | Active Comparator | Fibreoptic guided tracheal intubation through Protector |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-gel | Device | Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Intubation Time to Perform Fibreoptic Intubation | Time form insertion of bronchoscope through the supraglottic airway device to obtaining the capnography trace | less than 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| SAD Insertion Time | Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained | less than 1 minute |
| Number of Attempts at the SAD Placement |
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Inclusion Criteria:
• All patients aged above 18, presenting for elective surgical procedure, where a supraglottic airway device can be used and left in place throughout the duration of surgery and requiring tracheal intubation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cyprian Mendonca, Prof. | University Hospitals Coventry & Warwickshire NHS Trust, Clifford Bridge Road, Coventry CV2 2DX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Coventry & Warwickshire NHS Trust | Coventry | West Midlands | CV2 2DX | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26556848 | Background | Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10. | |
| 21652616 |
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| ID | Title | Description |
|---|---|---|
| FG000 | I-gel | Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway. |
| FG001 | LMA Protector | Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | I-gel | Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway. |
| BG001 | LMA Protector |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Intubation Time to Perform Fibreoptic Intubation | Time form insertion of bronchoscope through the supraglottic airway device to obtaining the capnography trace | In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation | Posted | Mean | Standard Deviation | seconds | less than 3 minutes |
|
1 year
In two patients randomly allocated to the LMA protector group, due to failed insertion of LMA protector the I-GEL was used instead In two patients allocated to the LMA protector group, due to failed intubation direct laryngoscopy was performed.
Therefore; the final number in I-GEL group is 92 and LMA Protector Group is 86(2 were allocated to I-GEL and 2 completely failed)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | I-gel | Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Cyprian Mendonca | University Hospitals Coventry & Warwickshire NHS Trust | 02476964000 | 25871 | cyprian.mendonca@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2017 | Aug 15, 2018 | Prot_SAP_000.pdf |
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| LMA Protector | Device | Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway. |
|
Number of attempts taken to successfully place the supraglottic airway device in the oropharynx
| less than 2 minutes |
| Number of Participants With Ease of Placement of the SAD | The ease of placement of the SAD assessed by the investigator on a four point scale:
4 - Failure | less than 2 minutes |
| Number of Participants With First and Second Attempt at Tracheal Intubation | Number of attempts at tracheal intubation. A new attempt is defined as re-insertion of the fibreoptic bronchoscope through the SAD. | less than 3 minutes |
| Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD | The quality of the view of the vocal cords seen through the SAD. It will be assessed, according to the previously published system, as: grade I - full view of the vocal cord, II - partial view of the vocal cords including arytenoids, III - epiglottis only, IV - other (SAD cuff, pharynx, others) | less than 3 minutes |
| Time to Carinal View | The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina. | less than 1 minute |
| Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation, | The number of tube rotations performed during tracheal intubation | less than 3 minutes |
| Oxford University Hospitals |
| Oxford |
| OX3 7LE |
| United Kingdom |
| Kleine-Brueggeney M, Theiler L, Urwyler N, Vogt A, Greif R. Randomized trial comparing the i-gel and Magill tracheal tube with the single-use ILMA and ILMA tracheal tube for fibreoptic-guided intubation in anaesthetized patients with a predicted difficult airway. Br J Anaesth. 2011 Aug;107(2):251-7. doi: 10.1093/bja/aer103. Epub 2011 Jun 7. |
| Background | El-Ganzouri, A. R., Marzouk, S., Abdelalem, N., & Yousef, M. (2011). Blind versus fiberoptic laryngoscopic intubation through air Q laryngeal mask airway. Egyptian Journal of Anaesthesia, 27(4), 213-218. |
| Background | Taxak, S., Vashisht, K., Kaur, K. P., Ahlawat, G., & Bhardwaj, M. (2013). A study to evaluate fibreoptic-guided intubation through the i-gel. Southern African Journal of Anaesthesia and Analgesia, 19(2), 120-123. |
| Background | Samir, E. M., & Sakr, S. A. (2012). The air-Q as a conduit for fiberoptic aided tracheal intubation in adult patients undergoing cervical spine fixation: A prospective randomized study. Egyptian Journal of Anaesthesia, 28(2), 133-137. |
| 25537736 | Background | Jagannathan N, Sohn L, Ramsey M, Huang A, Sawardekar A, Sequera-Ramos L, Kromrey L, De Oliveira GS. A randomized comparison between the i-gel and the air-Q supraglottic airways when used by anesthesiology trainees as conduits for tracheal intubation in children. Can J Anaesth. 2015 Jun;62(6):587-94. doi: 10.1007/s12630-014-0304-9. Epub 2014 Dec 24. |
| 22050948 | Background | Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3. |
| 23860341 | Background | Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available. |
| 21375088 | Background | Joffe AM, Liew EC, Galgon RE, Viernes D, Treggiari MM. The second-generation air-Q intubating laryngeal mask for airway maintenance during anaesthesia in adults: a report of the first 70 uses. Anaesth Intensive Care. 2011 Jan;39(1):40-5. doi: 10.1177/0310057X1103900106. |
Fibreoptic guided tracheal intubation through Protector
LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| LMA Protector |
Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway. |
|
|
| Secondary | SAD Insertion Time | Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained | In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation | Posted | Mean | Standard Deviation | seconds | less than 1 minute |
|
|
|
| Secondary | Number of Attempts at the SAD Placement | Number of attempts taken to successfully place the supraglottic airway device in the oropharynx | Not Posted | less than 2 minutes | Participants |
| Secondary | Number of Participants With Ease of Placement of the SAD | The ease of placement of the SAD assessed by the investigator on a four point scale:
4 - Failure | In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation | Posted | Number | participants | less than 2 minutes |
|
|
|
| Secondary | Number of Participants With First and Second Attempt at Tracheal Intubation | Number of attempts at tracheal intubation. A new attempt is defined as re-insertion of the fibreoptic bronchoscope through the SAD. | IIn 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation | Posted | Count of Participants | Participants | less than 3 minutes |
|
|
|
| Secondary | Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD | The quality of the view of the vocal cords seen through the SAD. It will be assessed, according to the previously published system, as: grade I - full view of the vocal cord, II - partial view of the vocal cords including arytenoids, III - epiglottis only, IV - other (SAD cuff, pharynx, others) | In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation | Posted | Count of Participants | Participants | less than 3 minutes |
|
|
|
| Secondary | Time to Carinal View | The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina. | In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation | Posted | Mean | Standard Deviation | seconds | less than 1 minute |
|
|
|
| Secondary | Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation, | The number of tube rotations performed during tracheal intubation | In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation | Posted | Count of Participants | Participants | less than 3 minutes |
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| 0 |
| 92 |
| EG001 | LMA Protector | Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway. | 0 | 86 | 0 | 86 | 0 | 86 |
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| Severe Resistance |
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| Failure |
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| Grade 3 |
|