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A study comparing two second generation supraglottic Airway devices, the VBM intubating laryngeal tube and the I-Gel.
This is a study comparing the use of a newer generation laryngeal mask to the 2nd generation widely used at present. The company responsible for the manufacture of this product is VBM Medizintechnik GmBH, Germany. The recent difficult airway society guidelines recommend the use of these newer generation devices and this has been the incentive to conduct this project. These newer generation supraglottic devices have an additional feature which is an extension of the mask with a balloon that sits in the oesophagus. The trial is investigating ease of placement of these devices, ventilatory pressures, leak pressure and ease of intubation through the VBM device compared to I-Gel. The position of the supraglottic device on insertion and the position of the endotracheal tube will be confirmed with a fibrescope. A follow up will take place on the same day and after 24 hours for symptoms of a sore throat postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VBM Intubating Laryngeal Tube | Active Comparator | Device: VBM Intubating Laryngeal Tube Intervention: VBM Intubating Laryngeal Tube insertion, seal pressure, endotracheal intubation |
|
| I-Gel | Active Comparator | Device: I-Gel Intervention: I-Gel insertion, seal pressure, endotracheal intubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VBM Intubating Laryngeal Tube | Device | The position of the VBM Intubating Laryngeal Tube will be assessed using a fibreoptic scope following balloon inflation of the cuff. Seal pressure will be assessed with the presence of the inflated cuff. Endotracheal intubation through the intubating laryngeal tube with a size 7 VBM reinforced tube will be assessed using a fiberoptic scope. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in seconds required for placement of supraglottic device | Time from device first enters mouth and appearance of end-tidal CO2 | Through study completion, an average of 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Seal pressure measured in cmH2O | Peak seal pressure when manual ventilation is commenced | Through study completion, an average of 30 minutes |
| Successful endotracheal intubation through the supraglottic airway, end tidal carbon dioxide monitoring in kilopascals |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imran Ahmad, MBBS | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26385673 | Result | Miller DM. Third generation supraglottic airways: is a new classification needed? Br J Anaesth. 2015 Oct;115(4):634-5. doi: 10.1093/bja/aev310. No abstract available. |
| Label | URL |
|---|---|
| Link to correspondence relating to the article | View source |
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No individual participant data will be made available
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| I-Gel | Device | The position of the I-Gel will be assessed using a fibreoptic scope. The seal pressure will be assessed with the specified design of the I-Gel in the absence of a cuff. Endotracheal intubation through the I-Gel with a size 7 reinforced endotracheal tube will be assessed using a fiberoptic scope. |
|
This is performed with the endotracheal tube mounted onto the fibreoptic scope and placed through the supraglottic device. The patients will be extubated immediately following the end of the surgical procedure which may take an average of approximately 2 hours. |
| Through study completion, an average of 30minutes |