Airway ManagementNCT03067246
A Comparison of the VBM Intubating Laryngeal Tube and the I-Gel
A study testing VBM Intubating Laryngeal Tube and I-Gel in people with Airway Management, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A study comparing two second generation supraglottic Airway devices, the VBM intubating laryngeal tube and the I-Gel. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- What is being tested?
- VBM Intubating Laryngeal Tube and I-Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to 5 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient between the age of 18 - 70
- Any patient having the capacity to consent
- Any patient requiring general anaesthesia but not endotracheal intubation immediately after induction of anaesthesia.
Who cannot join
- Patient refusal
- Patients involved in another research project
- Patients who require endotracheal intubation immediately after induction of anaesthesia
- Patients who are systemically unwell/unstable
- Patients at risk of aspiration
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas NHS Foundation Trust
London, SE1 9RT
About this study
Official title: A Comparison of Two Supraglottic Devices, the VBM Intubating Laryngeal Tube and I-Gel
A study comparing two second generation supraglottic Airway devices, the VBM intubating laryngeal tube and the I-Gel.
Read the 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.
- Conditions
- Airway Management
- Being tested
- VBM Intubating Laryngeal Tube, I-Gel
- Keywords
- Supraglottic device, Fibre optic scope, Endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBM Intubating Laryngeal TubeDevice
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-GelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| VBM Intubating Laryngeal Tube | Active comparator | Device: VBM Intubating Laryngeal Tube Intervention: VBM Intubating Laryngeal Tube insertion, seal pressure, endotracheal intubation Receives: Device: VBM Intubating Laryngeal Tube |
| I-Gel | Active comparator | Device: I-Gel Intervention: I-Gel insertion, seal pressure, endotracheal intubation Receives: Device: I-Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in seconds required for placement of supraglottic device
Time from device first enters mouth and appearance of end-tidal CO2
Measured: Through study completion, an average of 30 minutes
Secondary outcomes (2)
Seal pressure measured in cmH2O
Peak seal pressure when manual ventilation is commenced
Measured: Through study completion, an average of 30 minutes
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.
Measured: Through study completion, an average of 30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study startJan 2017
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Ahmad, MBBS, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067246
- Sponsor's protocol ID
- 16LO1210
- Status last verified
- Feb 2018
- First submitted
- 16 Dec 2016
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No individual participant data will be made available
Publications
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.
PubMed 26385673
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Supraglottic Devices, the VBM Intubating Laryngeal Tube and I-Gel
- ClinicalTrials.gov ID
- NCT03067246
- Acronym / sponsor ID
- 16LO1210
- Conditions
- Airway Management
- Keywords
- Supraglottic device, Fibre optic scope, Endotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VBM Intubating Laryngeal Tube | Active comparator | Device: VBM Intubating Laryngeal TubeDevice: VBM Intubating Laryngeal Tube Intervention: VBM Intubating Laryngeal Tube insertion, seal pressure, endotracheal intubation |
| I-Gel | Active comparator | Device: I-GelDevice: I-Gel Intervention: I-Gel insertion, seal pressure, endotracheal intubation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient between the age of 18 - 70
- Any patient having the capacity to consent
- Any patient requiring general anaesthesia but not endotracheal intubation immediately after induction of anaesthesia.
Key exclusion criteria (5 listed)
- Patient refusal
- Patients involved in another research project
- Patients who require endotracheal intubation immediately after induction of anaesthesia
- Patients who are systemically unwell/unstable
- Patients at risk of aspiration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VBM Intubating Laryngeal TubeThe 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. | Device | VBM Intubating Laryngeal Tube |
| I-GelThe 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. | Device | I-Gel |
Primary outcome
Time in seconds required for placement of supraglottic device
Time frame: Through study completion, an average of 30 minutes
Time from device first enters mouth and appearance of end-tidal CO2
2 secondary outcomes
Seal pressure measured in cmH2O
Time frame: Through study completion, an average of 30 minutes
Successful endotracheal intubation through the supraglottic airway, end tidal carbon dioxide monitoring in kilopascals
Time frame: Through study completion, an average of 30minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Results publication: PubMed 26385673Miller 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.
- Link to correspondence relating to the articleLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual participant data will be made available
Related trials for Airway Management
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Not yet recruitingObservational study
Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients
Frailty, Suboptimal Mask Ventilation
Not yet recruitingPhase 2
A Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imran Ahmad, MBBS principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VBM Intubating Laryngeal Tube and I-Gel in people with Airway Management, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in seconds required for placement of supraglottic device (time frame: Through study completion, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03067246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.