An interventional study of I-gel and LMA Protector in Intubation; Difficult or Failed, Laryngeal Masks and Airway Management, sponsored by University Hospitals Coventry and Warwickshire NHS Trust. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-09.
Sponsored by University Hospitals Coventry and Warwickshire NHS Trust · Not applicable, Interventional, and Treatment
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.
University Hospitals Coventry and Warwickshire NHS Trust is the lead sponsor of 54 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fibreoptic guided tracheal intubation through I-gel
Device: I-gel
Fibreoptic guided tracheal intubation through Protector
Device: LMA Protector
Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.
Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Total Intubation Time to Perform Fibreoptic Intubation
Time form insertion of bronchoscope through the supraglottic airway device to obtaining the capnography trace
Time frame: less than 3 minutes
SAD Insertion Time
Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained
Time frame: less than 1 minute
Number of Attempts at the SAD Placement
Number of attempts taken to successfully place the supraglottic airway device in the oropharynx
Time frame: 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: 1. - Easy 2. - Moderate Difficulty 3- Severe Difficulty 4 - Failure
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: less than 3 minutes
| Milestone | I-gel | LMA Protector |
|---|---|---|
| Started | 90 | 90 |
| Treated | 2 | 0 |
| Failed | 0 | 4 |
| Completed | 90 | 86 |
| Not completed | 0 | 4 |
Time form insertion of bronchoscope through the supraglottic airway device to obtaining the capnography trace
| seconds | I-gel | LMA Protector |
|---|---|---|
| Total Intubation Time to Perform Fibreoptic Intubation | 54.3 ± 13.8 | 52.0 ± 13 |
Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained
| seconds | I-gel | LMA Protector |
|---|---|---|
| SAD Insertion Time | 19.4 ± 5.6 | 25.4 ± 7.9 |
Number of attempts taken to successfully place the supraglottic airway device in the oropharynx
Results for this outcome have not been posted.
The ease of placement of the SAD assessed by the investigator on a four point scale: 1. - Easy 2. - Moderate Difficulty 3- Severe Difficulty 4 - Failure
| participants | I-gel | LMA Protector |
|---|---|---|
| Easy | 86 | 37 |
| Moderate Resistance | 6 | 44 |
| Severe Resistance | 0 | 5 |
| Failure | 0 | 0 |
Number of attempts at tracheal intubation. A new attempt is defined as re-insertion of the fibreoptic bronchoscope through the SAD.
| Participants | I-gel | LMA Protector |
|---|---|---|
| First Attempt | 90 | 84 |
| Second Attempt | 2 | 2 |
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)
| Participants | I-gel | LMA Protector |
|---|---|---|
| Grade 1 | 71 | 72 |
| Grade 2 | 20 | 14 |
| Grade 3 | 1 | 0 |
The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina.
| seconds | I-gel | LMA Protector |
|---|---|---|
| Time to Carinal View | 23.4 ± 10 | 21.9 ± 8.3 |
The number of tube rotations performed during tracheal intubation
| Participants | I-gel | LMA Protector |
|---|---|---|
| Tube impingement (Yes) | 38 | 23 |
| Tube impingement (No) | 54 | 63 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| I-gel | 0/92 (0%) | 0/92 (0%) | 0/92 (0%) |
| LMA Protector | 0/86 (0%) | 0/86 (0%) | 0/86 (0%) |
| Age, Categorical(Participants) | I-gel | LMA Protector | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 57 | 55 | 112 |
| >=65 years | 33 | 31 | 64 |
| Age, Continuous(years) | I-gel | LMA Protector | Total |
|---|---|---|---|
| Mean | 55.7 ± 15 | 54.7 ± 17 | 55 ± 15 |
| Sex: Female, Male(Participants) | I-gel | LMA Protector | Total |
|---|---|---|---|
| Female | 39 | 35 | 74 |
| Male | 51 | 51 | 102 |
| Race and Ethnicity Not Collected(Participants) | I-gel | LMA Protector | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | I-gel | LMA Protector | Total |
|---|---|---|---|
| United Kingdom | 90 | 86 | 176 |
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University Hospitals Coventry and Warwickshire NHS Trust