Airway Management Clinical Trial
Official title:
A Comparison of Two Supraglottic Devices, the VBM Intubating Laryngeal Tube and I-Gel
NCT number | NCT03067246 |
Other study ID # | 16LO1210 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | June 5, 2019 |
Verified date | February 2018 |
Source | Guy's and St Thomas' NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A study comparing two second generation supraglottic Airway devices, the VBM intubating laryngeal tube and the I-Gel.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 5, 2019 |
Est. primary completion date | June 5, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guy's and St Thomas NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Seal pressure measured in cmH2O | Peak seal pressure when manual ventilation is commenced | Through study completion, an average of 30 minutes | |
Secondary | Successful endotracheal intubation through the supraglottic airway, end tidal carbon dioxide monitoring in kilopascals | 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 |
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