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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

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

Clinical Trial Summary

A study comparing two second generation supraglottic Airway devices, the VBM intubating laryngeal tube and the I-Gel.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
VBM 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.
I-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.

Locations

Country Name City State
United Kingdom Guy's and St Thomas NHS Foundation Trust London

Sponsors (1)

Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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

Outcome

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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