Intubation; Difficult or Failed, Laryngeal Masks, Airway Management
Conditions
Keywords
intubation, tracheal, airway device, supra-glottic airway device, fibreoptic scope
Brief summary
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.
Detailed description
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.
Interventions
DEVICEI-gel
Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.
DEVICELMA Protector
Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* Patients who are do not wish to take part * Patients with class II obesity (BMI \>40) * Patients below 18 years of age * American Society of Anaesthesiologists (ASA 3, 4 and 5) * Patients with mouth opening of less than 3 cm * Patients deemed to require awake intubation * Surgery involving head and neck region * Surgery requiring prone position
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Intubation Time to Perform Fibreoptic Intubation | less than 3 minutes | Time form insertion of bronchoscope through the supraglottic airway device to obtaining the capnography trace |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts at the SAD Placement | less than 2 minutes | Number of attempts taken to successfully place the supraglottic airway device in the oropharynx |
| Number of Participants With Ease of Placement of the SAD | less than 2 minutes | 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 |
| Number of Participants With First and Second Attempt at Tracheal Intubation | less than 3 minutes | Number of attempts at tracheal intubation. A new attempt is defined as re-insertion of the fibreoptic bronchoscope through the SAD. |
| SAD Insertion Time | less than 1 minute | Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained |
| Time to Carinal View | less than 1 minute | The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina. |
| Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation, | less than 3 minutes | The number of tube rotations performed during tracheal intubation |
| Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD | less than 3 minutes | 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) |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 90 |
| 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. | 86 |
| Total | 176 |
Baseline characteristics
| Characteristic | LMA Protector | Total | I-gel |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 64 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 112 Participants | 57 Participants |
| Age, Continuous | 54.7 years STANDARD_DEVIATION 17 | 55 years STANDARD_DEVIATION 15 | 55.7 years STANDARD_DEVIATION 15 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 86 participants | 176 participants | 90 participants |
| Sex: Female, Male Female | 35 Participants | 74 Participants | 39 Participants |
| Sex: Female, Male Male | 51 Participants | 102 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 86 |
| other Total, other adverse events | 0 / 92 | 0 / 86 |
| serious Total, serious adverse events | 0 / 92 | 0 / 86 |
Outcome results
Primary
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
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-gel | Total Intubation Time to Perform Fibreoptic Intubation | 54.3 seconds | Standard Deviation 13.8 |
| LMA Protector | Total Intubation Time to Perform Fibreoptic Intubation | 52.0 seconds | Standard Deviation 13 |
Secondary
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
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: 1. \- Easy 2. \- Moderate Difficulty 3- Severe Difficulty 4 - Failure
Time frame: less than 2 minutes
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| I-gel | Number of Participants With Ease of Placement of the SAD | Easy | 86 participants |
| I-gel | Number of Participants With Ease of Placement of the SAD | Moderate Resistance | 6 participants |
| I-gel | Number of Participants With Ease of Placement of the SAD | Severe Resistance | 0 participants |
| I-gel | Number of Participants With Ease of Placement of the SAD | Failure | 0 participants |
| LMA Protector | Number of Participants With Ease of Placement of the SAD | Failure | 0 participants |
| LMA Protector | Number of Participants With Ease of Placement of the SAD | Easy | 37 participants |
| LMA Protector | Number of Participants With Ease of Placement of the SAD | Severe Resistance | 5 participants |
| LMA Protector | Number of Participants With Ease of Placement of the SAD | Moderate Resistance | 44 participants |
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.
Time frame: less than 3 minutes
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| I-gel | Number of Participants With First and Second Attempt at Tracheal Intubation | First Attempt | 90 Participants |
| I-gel | Number of Participants With First and Second Attempt at Tracheal Intubation | Second Attempt | 2 Participants |
| LMA Protector | Number of Participants With First and Second Attempt at Tracheal Intubation | First Attempt | 84 Participants |
| LMA Protector | Number of Participants With First and Second Attempt at Tracheal Intubation | Second Attempt | 2 Participants |
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)
Time frame: less than 3 minutes
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| I-gel | Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD | Grade 1 | 71 Participants |
| I-gel | Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD | Grade 2 | 20 Participants |
| I-gel | Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD | Grade 3 | 1 Participants |
| LMA Protector | Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD | Grade 1 | 72 Participants |
| LMA Protector | Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD | Grade 2 | 14 Participants |
| LMA Protector | Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD | Grade 3 | 0 Participants |
Secondary
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
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| I-gel | Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation, | Tube impingement (Yes) | 38 Participants |
| I-gel | Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation, | Tube impingement (No) | 54 Participants |
| LMA Protector | Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation, | Tube impingement (Yes) | 23 Participants |
| LMA Protector | Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation, | Tube impingement (No) | 63 Participants |
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
Time frame: less than 1 minute
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-gel | SAD Insertion Time | 19.4 seconds | Standard Deviation 5.6 |
| LMA Protector | SAD Insertion Time | 25.4 seconds | Standard Deviation 7.9 |
Secondary
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
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-gel | Time to Carinal View | 23.4 seconds | Standard Deviation 10 |
| LMA Protector | Time to Carinal View | 21.9 seconds | Standard Deviation 8.3 |