Difficult Intubation
Conditions
Keywords
Intubation
Brief summary
The investigators plan to conduct a randomized trial comparing the efficacy of intubating the tracheal using an Aintree intubation catheter through either the LMA-S or I-gel supraglottic devices
Detailed description
With the proposal, the investigators are comparing two different types of supraglottic devices. One is the LMA Supreme (laryngeal mask airway) and the other is the I-gel. The study is designed to use the supraglottic airway device as an adjunct to tracheal intubation, not as the definitive airway. The investigators will be utilizing the Aintree intubation catheter over the fiberoptic bronchoscope in an effort to secure the airway. This technique has been well described in the literature and has been proven effective and safe.
Interventions
DEVICELMA-Supreme supraglottic device
The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
DEVICEI-gel supraglottic device
The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects that will require routine endotracheal intubation for general anesthesia as part of their surgery. * Age \>18 years old. * Can provide informed consent.
Exclusion criteria
* Subjects that require rapid sequence induction for endotracheal intubation; i.e., parturients, or any subject that is at high risk for aspirating gastric contents into the airway. * Subjects that have an allergy to Propofol or eggs. * Subjects that have an allergy to rocuronium. * Subjects with a history of oropharyngeal or laryngeal surgery, or subjects undergoing oropharyngeal or laryngeal surgery. * Subjects with congenital or anatomical airway anomalies. * Subjects with anticipated reduced functional residual capacity as predicted by a body mass index ≥40. * Currently enrolled in another research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Successful Tracheal Intubation | Up to 10 minutes | This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Placement of the Supra Glottic Device | Up to 10 minutes | This measure of time begins with the handling of the supra glottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide |
| Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device | Up to 10 minutes | Percent of subjects who required 0, 1, 2, and 3 airway manipulations for the placement of the supraglottic device |
| Time to Placement of the Aintree Airway Intubation Catheter | Up to 10 minutes | This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down |
| Time to Placement of the Endotrotracheal Tube | Up to 10 minutes | Time to the appropriate placement of the endotracheal tube. |
| Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube | Up to 10 minutes | Percent of subjects with 0, 1, 2 and 3 airway manipulations required for placement of endotrachial tube |
| Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | Up to 10 minutes | Percent of subjects who required 0, 1, 2, 3 and 6 airway manipulations for the placement of the Aintree. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visualization Score | Up to 10 minutes | The visualization of each of the following structures provides one point, for a maximum score of 7. 1. Right true vocal cord. 2. Left true vocal cord. 3. Right false vocal cord. 4. Left false vocal cord. 5. Right posterior cartilage 6. Left posterior cartilage 7. Epiglottis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LMA-Supreme Supraglottic Device The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. | 19 |
| I-gel Supraglottic Device The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway. | 20 |
| Total | 39 |
Baseline characteristics
| Characteristic | LMA-Supreme Supraglottic Device | I-gel Supraglottic Device | Total |
|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 15 | 58 years STANDARD_DEVIATION 14 | 56 years STANDARD_DEVIATION 14 |
| Body Mass Index (BMI) | 28.3 kg/m2 STANDARD_DEVIATION 8 | 27.3 kg/m2 STANDARD_DEVIATION 8.3 | 27.7 kg/m2 STANDARD_DEVIATION 8.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 1 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
Time to Successful Tracheal Intubation
This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide.
Time frame: Up to 10 minutes
Population: unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-gel Supraglottic Device | Time to Successful Tracheal Intubation | 197 seconds | Standard Deviation 93 |
| LMA-Supreme Supraglottic Device | Time to Successful Tracheal Intubation | 304 seconds | Standard Deviation 173 |
Secondary
Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.
Percent of subjects who required 0, 1, 2, 3 and 6 airway manipulations for the placement of the Aintree.
Time frame: Up to 10 minutes
Population: 2 participants in I-gel arm were excluded from analysis because times to established safety cutoff for airway establishment(10 minutes) was exceeded. 3 participants in LMA-Supreme arm were excluded in analysis because study was aborted at request of attending or times to established safety cutoff for airway establishment (10 minutes) was exceeded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| I-gel Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | 0 manipulations | 67 percent of participants |
| I-gel Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | 2 manipulations | 0 percent of participants |
| I-gel Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | 1 manipulations | 33 percent of participants |
| I-gel Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | 3 manipulations | 0 percent of participants |
| I-gel Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | 6 manipulations | 0 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | 3 manipulations | 12 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | 6 manipulations | 6 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | 0 manipulations | 25 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | 1 manipulations | 25 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree. | 2 manipulations | 31 percent of participants |
Secondary
Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device
Percent of subjects who required 0, 1, 2, and 3 airway manipulations for the placement of the supraglottic device
Time frame: Up to 10 minutes
Population: 4 participants in the LMA-Supreme arm were not included in analysis because the study was aborted at the request of the attending or the times to established safety cutoff for airway establishment (10 minutes) was exceeded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| I-gel Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device | 0 manipulations | 80 percent of participants |
| I-gel Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device | 1 manipulations | 10 percent of participants |
| I-gel Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device | 2 manipulations | 5 percent of participants |
| I-gel Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device | 3 manipulations | 5 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device | 3 manipulations | 0 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device | 0 manipulations | 80 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device | 2 manipulations | 7 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device | 1 manipulations | 13 percent of participants |
Secondary
Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube
Percent of subjects with 0, 1, 2 and 3 airway manipulations required for placement of endotrachial tube
Time frame: Up to 10 minutes
Population: 2 participants in I-gel arm were excluded from analysis because times to established safety cutoff for airway establishment(10 minutes) was exceeded. 5 participants in LMA-Supreme arm were excluded in analysis because study was aborted at request of attending or times to established safety cutoff for airway establishment (10 minutes) was exceeded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| I-gel Supraglottic Device | Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube | 1 manipulations | 17 percent of participants |
| I-gel Supraglottic Device | Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube | 2 manipulations | 11 percent of participants |
| I-gel Supraglottic Device | Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube | 0 manipulations | 67 percent of participants |
| I-gel Supraglottic Device | Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube | 3 manipulations | 6 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube | 2 manipulations | 0 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube | 1 manipulations | 43 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube | 0 manipulations | 57 percent of participants |
| LMA-Supreme Supraglottic Device | Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube | 3 manipulations | 0 percent of participants |
Secondary
Time to Placement of the Aintree Airway Intubation Catheter
This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down
Time frame: Up to 10 minutes
Population: unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-gel Supraglottic Device | Time to Placement of the Aintree Airway Intubation Catheter | 155 seconds | Standard Deviation 182 |
| LMA-Supreme Supraglottic Device | Time to Placement of the Aintree Airway Intubation Catheter | 301 seconds | Standard Deviation 246 |
Secondary
Time to Placement of the Endotrotracheal Tube
Time to the appropriate placement of the endotracheal tube.
Time frame: Up to 10 minutes
Population: unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-gel Supraglottic Device | Time to Placement of the Endotrotracheal Tube | 81 second | Standard Deviation 71 |
| LMA-Supreme Supraglottic Device | Time to Placement of the Endotrotracheal Tube | 96 second | Standard Deviation 117 |
Secondary
Time to Placement of the Supra Glottic Device
This measure of time begins with the handling of the supra glottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide
Time frame: Up to 10 minutes
Population: unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-gel Supraglottic Device | Time to Placement of the Supra Glottic Device | 155 seconds | Standard Deviation 182 |
| LMA-Supreme Supraglottic Device | Time to Placement of the Supra Glottic Device | 301 seconds | Standard Deviation 246 |
Other Pre-specified
Visualization Score
The visualization of each of the following structures provides one point, for a maximum score of 7. 1. Right true vocal cord. 2. Left true vocal cord. 3. Right false vocal cord. 4. Left false vocal cord. 5. Right posterior cartilage 6. Left posterior cartilage 7. Epiglottis
Time frame: Up to 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| I-gel Supraglottic Device | Visualization Score | 6.0 units on a scale | Standard Deviation 1.3 |
| LMA-Supreme Supraglottic Device | Visualization Score | 3.4 units on a scale | Standard Deviation 2.9 |