Staff AnaesthesiologistsNCT02640196
Videolaryngoscopes for Double Lumen Tube Intubations in Simulated Easy and Difficult Airway
A study testing Macintosh, GlideScope and Airtraq in people with Staff Anaesthesiologists and Limited Experience in Using Videolaryngoscopes, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
The investigators hypothesized that the use of the King Vision™ and the Airtraq® VL would reduce the time to DLT intubation compared with the GlideScope® and Macintosh in simulated easy and difficult airways. Read more about this study
- Who is it for?
- Ages 23 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Staff Anaesthesiologists, Limited Experience in Using Videolaryngoscopes
- What is being tested?
- Macintosh, GlideScope and Airtraq
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2015to Jun 2015
- 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 23 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Staff anesthesiologists
- Signed consent
- Limited experience in using videolaryngoscopes for inserting double lumen tubes
Who cannot join
- Decline to sign the consent
- Non receiving the prior training demonstration
- Non practicing once with each device tested on each simulator scenario
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Three Videolaryngoscopes for Double-lumen Tubes Intubation in Simulated Easy and Difficult Airways
The investigators hypothesized that the use of the King Vision™ and the Airtraq® VL would reduce the time to DLT intubation compared with the GlideScope® and Macintosh in simulated easy and difficult airways. The investigators have considered to assess the efficacy of each device in manikins before considering to evaluate them in patients undergoing thoracic procedures.
Twenty-one staff anaesthesiologists who had limited prior experience in using the VLs for DLT intubation participated in this randomised crossover study. Following a brief demonstration and two practice attempts, participants were volunteered to insert a DLT using the Macintosh, GlideScope®, Airtraq®, and King Vision™ on two high-fidelity easy and difficult airway simulators in a computer-generated randomized sequence. The primary endpoint, time to DLT intubation, as well as, the views obtained at laryngoscopy, ease of intubation, numbers of laryngoscopy attempts and optimisation manoeuvers, and failure to intubation; defined as an attempt took longer than 150 seconds, were recorded.
Read the detailed description
Several regional surveys demonstrated that most thoracic anesthesiologists are using the double-lumen endobronchial tubes (DLT) as the first-choice lung separation technique. DLT, when compared with single lumen tracheal tube, can be more difficult to insert in patients with difficult airways. The videolaryngoscopes (VL) have the potential to facilitate the placement of the DLTs for lung separation in patients with predicted or unanticipated difficult airway.
The use of GlideScope® (Verathon Inc., Bothell, WA, USA), a VL with an angulated blade, has been associated with variable times to DLT intubation according to the prior experience of the operators, despite superior visualization of the glottis The channeled Airtraq® (Prodol Meditec S.A., Vizcaya, Spain) and standard non-channeled blade of the King Vision™ (Ambu, Ballerup, Copenhagen, Denmark), may offer additional benefits for DLT intubation in patients with limited mouth opening or restricted neck movement, in whom the use of traditional VL like as the Glidescope® could be difficult. This is because of the larger outer diameter, the distal curvature and the increased rigidity of the DLT. Of note, the longer times to DLT intubation with the use of different VL could be shortened with building up the operator's experience.
To the best of the investigators knowledge, the comparison of the effects of the Macintosh, GlideScope®, Airtraq®, and King Vision™ VL on the time to DLT intubation in simulated easy and difficult airways has not yet been studied.
Two high-fidelity simulators (Airway Management Trainer, model AA-3100, Laerdal, Kent, UK) were prepared to simulate easy and difficult airway situations, as described by Marshall et al. and Wang et al. The "easy" airway was established with the manikin in a neutral position. The "difficult" airway setting was obtained by placing an Oasis Elite™ Prone Head Rest, Adult (140 mm in height) (Covidien, Mansfield, MA) under the occiput and securing the head position with adhesive tape, object to replicate cervical-collar use. Positioning was confirmed after each attempt to ensure consistency.
- Being tested
- Macintosh, GlideScope, Airtraq, King Vision
- Keywords
- Laryngoscope, Macintosh, Glidescope, King Vision, Airtraq, Double Lumen Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacintoshDevice
The participants intubated the easy airway simulator with a double lumen tube using the Macintosh laryngoscope followed with intubating the difficult airway simulator
GlideScopeDevice
The participants intubated the easy airway simulator with a double lumen tube using the GlideScope followed with intubating the difficult airway simulator
AirtraqDevice
The participants intubated the easy airway simulator with a double lumen tube using the Airtraq followed with intubating the difficult airway simulator
King VisionDevice
The participants intubated the easy airway simulator with a double lumen tube using the King Vision followed with intubating the difficult airway simulator
| Study group | Role | What they receive |
|---|---|---|
| Macintosh | Placebo comparator | The participants intubated the easy airway simulator with a double lumen tube using the Macintosh laryngoscope followed with intubating the difficult airway simulator Receives: Device: Macintosh |
| GlideScope | Placebo comparator | The participants intubated the easy airway simulator with a double lumen tube using the GlideScope laryngoscope followed with intubating the difficult airway simulator Receives: Device: GlideScope |
| Airtraq | Active comparator | The participants intubated the easy airway simulator with a double lumen tube using the Airtraq laryngoscope followed with intubating the difficult airway simulator Receives: Device: Airtraq |
| King Vision | Active comparator | The participants intubated the easy airway simulator with a double lumen tube using the King Vision followed with intubating the difficult airway simulator Receives: Device: King Vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve successful double lumen tube intubation
defined as the time when the investigated laryngoscope passed the central incisors to when the tip of the bronchial lumen passed through the glottis, as confirmed visually by the operator (in the Macintosh group) or by the investigator, thanks to remote screens (in the VLs groups).
Measured: for 6 min after using each device
Secondary outcomes (4)
Best view during laryngoscopy using the classification described by Cormack and Lehane
using the classification described by Cormack and Lehane
Measured: for 1 min after laryngoscopy
Difficulty of intubation using a Visual Analog Scale (VAS)
The difficulty of intubation was evaluated using a visual analog scale (VAS) (ranging from 0: extremely easy, to 100: extremely difficult) expressed by the anesthesiologists after the DLT intubation
Measured: for 6 min after using each device
Number of first-pass success
first-pass success calculated as number of first-attempt successes/number of patients with an intubation attempt
Measured: for 3 min after using each device
Number of the required optimisation manoeuvers
When the anaesthesiologists encountered difficulty in visualising vocal cords or placing the tube, they were allowed to use any manoeuver they would normally use to navigate the tube into the trachea including readjustment of the blade or tube or to ask the supervising investigator to help solve the problem, and gave suggestions or instructions
Measured: for 6 min after using each device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staff AnaesthesiologistsStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed R El Tahan, MD, Principal investigator, Anesthesiology Department, Dammam University, Dammam, Saudi ArabiaAbdulmohsen A Al Ghamdi, MD, Study director, Anesthesiology Department, Dammam University, Dammam, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640196
- Sponsor's protocol ID
- ANESTH-03-15
- Status last verified
- Dec 2015
- First submitted
- 22 Dec 2015
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Three Videolaryngoscopes for Double-lumen Tubes Intubation in Simulated Easy and Difficult Airways
- ClinicalTrials.gov ID
- NCT02640196
- Acronym / sponsor ID
- ANESTH-03-15
- Keywords
- Laryngoscope, Macintosh, Glidescope, King Vision, Airtraq, Double Lumen Tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Dec 2015 (estimated)
- 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.
The investigators hypothesized that the use of the King Vision™ and the Airtraq® VL would reduce the time to DLT intubation compared with the GlideScope® and Macintosh in simulated easy and difficult airways. The investigators have considered to assess the efficacy of each device in manikins before considering to evaluate them in patients undergoing thoracic procedures.
Twenty-one staff anaesthesiologists who had limited prior experience in using the VLs for DLT intubation participated in this randomised crossover study. Following a brief demonstration and two practice attempts, participants were volunteered to insert a DLT using the Macintosh, GlideScope®, Airtraq®, and King Vision™ on two high-fidelity easy and difficult airway simulators in a computer-generated randomized sequence. The primary endpoint, time to DLT intubation, as well as, the views obtained at laryngoscopy, ease of intubation, numbers of laryngoscopy attempts and optimisation manoeuvers, and failure to intubation; defined as an attempt took longer than 150 seconds, were recorded.
Detailed description
Several regional surveys demonstrated that most thoracic anesthesiologists are using the double-lumen endobronchial tubes (DLT) as the first-choice lung separation technique. DLT, when compared with single lumen tracheal tube, can be more difficult to insert in patients with difficult airways. The videolaryngoscopes (VL) have the potential to facilitate the placement of the DLTs for lung separation in patients with predicted or unanticipated difficult airway.
The use of GlideScope® (Verathon Inc., Bothell, WA, USA), a VL with an angulated blade, has been associated with variable times to DLT intubation according to the prior experience of the operators, despite superior visualization of the glottis The channeled Airtraq® (Prodol Meditec S.A., Vizcaya, Spain) and standard non-channeled blade of the King Vision™ (Ambu, Ballerup, Copenhagen, Denmark), may offer additional benefits for DLT intubation in patients with limited mouth opening or restricted neck movement, in whom the use of traditional VL like as the Glidescope® could be difficult. This is because of the larger outer diameter, the distal curvature and the increased rigidity of the DLT. Of note, the longer times to DLT intubation with the use of different VL could be shortened with building up the operator's experience.
To the best of the investigators knowledge, the comparison of the effects of the Macintosh, GlideScope®, Airtraq®, and King Vision™ VL on the time to DLT intubation in simulated easy and difficult airways has not yet been studied.
Two high-fidelity simulators (Airway Management Trainer, model AA-3100, Laerdal, Kent, UK) were prepared to simulate easy and difficult airway situations, as described by Marshall et al. and Wang et al. The "easy" airway was established with the manikin in a neutral position. The "difficult" airway setting was obtained by placing an Oasis Elite™ Prone Head Rest, Adult (140 mm in height) (Covidien, Mansfield, MA) under the occiput and securing the head position with adhesive tape, object to replicate cervical-collar use. Positioning was confirmed after each attempt to ensure consistency.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Macintosh | Placebo comparator | Device: MacintoshThe participants intubated the easy airway simulator with a double lumen tube using the Macintosh laryngoscope followed with intubating the difficult airway simulator |
| GlideScope | Placebo comparator | Device: GlideScopeThe participants intubated the easy airway simulator with a double lumen tube using the GlideScope laryngoscope followed with intubating the difficult airway simulator |
| Airtraq | Active comparator | Device: AirtraqThe participants intubated the easy airway simulator with a double lumen tube using the Airtraq laryngoscope followed with intubating the difficult airway simulator |
| King Vision | Active comparator | Device: King VisionThe participants intubated the easy airway simulator with a double lumen tube using the King Vision followed with intubating the difficult airway simulator |
Who may qualify
- Ages
- 23 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Staff anesthesiologists
- Signed consent
- Limited experience in using videolaryngoscopes for inserting double lumen tubes
Key exclusion criteria (3 listed)
- Decline to sign the consent
- Non receiving the prior training demonstration
- Non practicing once with each device tested on each simulator scenario
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 |
|---|---|---|
| MacintoshThe participants intubated the easy airway simulator with a double lumen tube using the Macintosh laryngoscope followed with intubating the difficult airway simulator | Device | Macintosh |
| GlideScopeThe participants intubated the easy airway simulator with a double lumen tube using the GlideScope followed with intubating the difficult airway simulator | Device | GlideScope |
| AirtraqThe participants intubated the easy airway simulator with a double lumen tube using the Airtraq followed with intubating the difficult airway simulator | Device | Airtraq |
| King VisionThe participants intubated the easy airway simulator with a double lumen tube using the King Vision followed with intubating the difficult airway simulator | Device | King Vision |
Primary outcome
Time to achieve successful double lumen tube intubation
Time frame: for 6 min after using each device
defined as the time when the investigated laryngoscope passed the central incisors to when the tip of the bronchial lumen passed through the glottis, as confirmed visually by the operator (in the Macintosh group) or by the investigator, thanks to remote screens (in the VLs groups).
4 secondary outcomes
Best view during laryngoscopy using the classification described by Cormack and Lehane
Time frame: for 1 min after laryngoscopy
Difficulty of intubation using a Visual Analog Scale (VAS)
Time frame: for 6 min after using each device
Number of first-pass success
Time frame: for 3 min after using each device
Number of the required optimisation manoeuvers
Time frame: for 6 min after using each device
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 28 Dec 2015.
- Individual participant dataSharing planned: No
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.
Mohamed R El Tahan, MD principal investigator
Anesthesiology Department, Dammam University, Dammam, Saudi Arabia
Abdulmohsen A Al Ghamdi, MD study director
Anesthesiology Department, Dammam University, Dammam, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh, GlideScope and Airtraq in people with Staff Anaesthesiologists and Limited Experience in Using Videolaryngoscopes, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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 3 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 28 Dec 2015. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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 to achieve successful double lumen tube intubation (time frame: for 6 min after using each device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2015.