Airway Management
Conditions
Keywords
Supraglottic device, Fibre optic scope, Endotracheal intubation
Brief summary
A study comparing two second generation supraglottic Airway devices, the VBM intubating laryngeal tube and the I-Gel.
Detailed description
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.
Interventions
DEVICEI-Gel
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.
DEVICEVBM Intubating Laryngeal Tube
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.
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Any patient between the age of 18 - 70 2. Any patient having the capacity to consent 3. Any patient requiring general anaesthesia but not endotracheal intubation immediately after induction of anaesthesia.
Exclusion criteria
1. Patient refusal 2. Patients involved in another research project 3. Patients who require endotracheal intubation immediately after induction of anaesthesia 4. Patients who are systemically unwell/unstable 5. Patients at risk of aspiration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in seconds required for placement of supraglottic device | Through study completion, an average of 30 minutes | Time from device first enters mouth and appearance of end-tidal CO2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seal pressure measured in cmH2O | Through study completion, an average of 30 minutes | Peak seal pressure when manual ventilation is commenced |
| Successful endotracheal intubation through the supraglottic airway, end tidal carbon dioxide monitoring in kilopascals | Through study completion, an average of 30minutes | 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. |
Countries
United Kingdom
Outcome results
None listed