A Comparison of the VBM Intubating Laryngeal Tube and the I-Gel

• Sponsor: Guy's and St Thomas' NHS Foundation Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT03067246
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 29.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Airway Management	Device: VBM Intubating Laryngeal Tube; Device: I-Gel	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: A Comparison of Two Supraglottic Devices, the VBM Intubating Laryngeal Tube and I-Gel
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jun 5, 2019
• Actual Study Completion Date: Jun 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: VBM Intubating Laryngeal Tube Device: VBM Intubating Laryngeal Tube Intervention: VBM Intubating Laryngeal Tube insertion, seal pressure, endotracheal intubation	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.
Active Comparator: I-Gel Device: I-Gel Intervention: I-Gel insertion, seal pressure, endotracheal intubation	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Seal pressure measured in cmH2O [Through study completion, an average of 30 minutes]

   Peak seal pressure when manual ventilation is commenced

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guy's and St Thomas NHS Foundation Trust	London		United Kingdom	SE1 9RT

Sponsors and Collaborators

• Guy's and St Thomas' NHS Foundation Trust

Investigators

• Principal Investigator: Imran Ahmad, MBBS, Guy's and St Thomas' NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Link to correspondence relating to the article

Publications

None provided.

• Responsible Party: Guy's and St Thomas' NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT03067246
• Other Study ID Numbers: 16LO1210
• First Posted: Mar 1, 2017
• Last Update Posted: Jul 31, 2019
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Guy's and St Thomas' NHS Foundation Trust: Supraglottic device; Fibre optic scope; Endotracheal intubation

Study Results

No Results Posted as of Jul 31, 2019