Airway Complication of AnaesthesiaPhase 4NCT01491984
Effectiveness and Safety of the Levitan Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway
A Phase 4 study testing Laryngoscopy order: 1) MAC, 2) Levitan and Laryngoscopy order: 1) Levitan, 2) MAC in people with Airway Complication of Anaesthesia, run by IWK Health Centre.
Trial summary
A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called… Read more about this study
- Who is it for?
- Ages 16 to 75 years, women only
- Conditions the study is for
- Airway Complication of Anaesthesia
- What is being tested?
- Laryngoscopy order: 1) MAC, 2) Levitan and Laryngoscopy order: 1) Levitan, 2) MAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jul 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I or II (healthy or mild systemic disease, ex. asthma, high blood pressure)
- Elective surgery requiring endotracheal intubation
- English speaking
- Age 16 - 75 years
Who cannot join
- Significant gastroesophageal reflux disease (GERD) that may require alternate induction/intubation techniques
- Prior history of a difficult intubation requiring an awake tracheal intubation
- Clinical predictors of a potentially difficult intubation requiring an awake intubation
- BMI > 45 kg/m2 (Obesity is a common and important risk factor for difficult intubation)
About this study
Official title: Effectiveness and Safety of the Levitan FPS Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway in Surgical Subjects Under General Anesthesia
A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation.
Read the detailed description
A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation. The placement of a breathing tube into the windpipe is a skill that is not easily mastered. In fact, the placement is difficult or impossible using the usual technique in 1-3 of every 100 patients. The ease of placing this breathing tube depends in part on how easily and how much of the vocal cords are able to be seen directly using a laryngoscope.
In a small number of patients, the Levitan First Pass Success (FPS) Scope has been shown to be more effective and easier to insert even in patients who have difficult airways. This study will evaluate the use of the LFS compared to the other conventional laryngoscope in subjects with a simulated difficult airway. The goal of this study is to determine the effectiveness and safety of the LFS in a large number of patients with simulated airway difficulties.
The results obtained during the study may provide useful information to health care providers who cannot place a breathing tube in patients that are either in operating rooms or in emergency situations requiring intubation by paramedics. An example would be a trauma situation where a paramedic is having difficulty attempting an intubation when a patients c-spine is being protected from any movements.
The LFS is an affordable and transportable device, which makes this an attractive asset for health providers in smaller community settings or in paramedic vehicles which may not have the capacity to stock or ability to afford a variety of different scopes and must choose a more limited selection.
- Conditions
- Airway Complication of Anaesthesia
- Being tested
- Laryngoscopy order: 1) MAC, 2) Levitan, Laryngoscopy order: 1) Levitan, 2) MAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngoscopy order: 1) MAC, 2) LevitanDevice
Laryngoscopy with MAC, then Levitan
Laryngoscopy order: 1) Levitan, 2) MACDevice
Laryngoscopy with Levitan, then MAC
| Study group | Role | What they receive |
|---|---|---|
| Laryngoscopy order: 1) MAC, 2) Levitan | Experimental | Levitan FPS Intubation Receives: Device: Laryngoscopy order: 1) MAC, 2) Levitan; Device: Laryngoscopy order: 1) Levitan, 2) MAC |
| Laryngoscopy order: 1) Levitan, 2) MAC | Experimental | Macintosh Intubation Receives: Device: Laryngoscopy order: 1) MAC, 2) Levitan; Device: Laryngoscopy order: 1) Levitan, 2) MAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack-Lehane Grade
The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale.
Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen
Measured: intraoperative
Secondary outcomes (3)
Number of Intubation Attempts
Number of intubation attempts was recorded after intubation was completed.
Measured: intraoperative
Operator Rating of Difficulty
The attending anesthesiologist rated the difficulty in using each technique to intubate the larynx using an 11-point numeric rating scale and a 4-point visual rating scale.
Measured: intraoperative
Time to Successful Intubation
Time to successful intubation was documented during the second laryngoscopy and defined as the time from the insertion of the Macintosh laryngoscope into the oral cavity to its removal.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Airway Complication of AnaesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald George, IWK Health Centre
- Investigators
- Ronald B George, MD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491984
- Sponsor's protocol ID
- IWK-4668-2009
- Other IDs
- IWK REB 4668
- Status last verified
- Feb 2015
- First submitted
- 12 Dec 2011
- Last updated
- 10 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of the Levitan FPS Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway in Surgical Subjects Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01491984
- Acronym / sponsor ID
- IWK-4668-2009
- Conditions
- Airway Complication of Anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Posted 10 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation.
Detailed description
A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation. The placement of a breathing tube into the windpipe is a skill that is not easily mastered. In fact, the placement is difficult or impossible using the usual technique in 1-3 of every 100 patients. The ease of placing this breathing tube depends in part on how easily and how much of the vocal cords are able to be seen directly using a laryngoscope.
In a small number of patients, the Levitan First Pass Success (FPS) Scope has been shown to be more effective and easier to insert even in patients who have difficult airways. This study will evaluate the use of the LFS compared to the other conventional laryngoscope in subjects with a simulated difficult airway. The goal of this study is to determine the effectiveness and safety of the LFS in a large number of patients with simulated airway difficulties.
The results obtained during the study may provide useful information to health care providers who cannot place a breathing tube in patients that are either in operating rooms or in emergency situations requiring intubation by paramedics. An example would be a trauma situation where a paramedic is having difficulty attempting an intubation when a patients c-spine is being protected from any movements.
The LFS is an affordable and transportable device, which makes this an attractive asset for health providers in smaller community settings or in paramedic vehicles which may not have the capacity to stock or ability to afford a variety of different scopes and must choose a more limited selection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngoscopy order: 1) MAC, 2) Levitan | Experimental | Device: Laryngoscopy order: 1) MAC, 2) Levitan, Device: Laryngoscopy order: 1) Levitan, 2) MACLevitan FPS Intubation |
| Laryngoscopy order: 1) Levitan, 2) MAC | Experimental | Device: Laryngoscopy order: 1) MAC, 2) Levitan, Device: Laryngoscopy order: 1) Levitan, 2) MACMacintosh Intubation |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status I or II (healthy or mild systemic disease, ex. asthma, high blood pressure)
- Elective surgery requiring endotracheal intubation
- English speaking
- Age 16 - 75 years
Key exclusion criteria (4 listed)
- Significant gastroesophageal reflux disease (GERD) that may require alternate induction/intubation techniques
- Prior history of a difficult intubation requiring an awake tracheal intubation
- Clinical predictors of a potentially difficult intubation requiring an awake intubation
- BMI > 45 kg/m2 (Obesity is a common and important risk factor for difficult intubation)
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 |
|---|---|---|
| Laryngoscopy order: 1) MAC, 2) LevitanLaryngoscopy with MAC, then Levitan | Device | Laryngoscopy order: 1) Levitan, 2) MAC, Laryngoscopy order: 1) MAC, 2) Levitan |
| Laryngoscopy order: 1) Levitan, 2) MACLaryngoscopy with Levitan, then MAC | Device | Laryngoscopy order: 1) Levitan, 2) MAC, Laryngoscopy order: 1) MAC, 2) Levitan |
Primary outcome
Cormack-Lehane Grade
Time frame: intraoperative
The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale. Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen
3 secondary outcomes
Number of Intubation Attempts
Time frame: intraoperative
Operator Rating of Difficulty
Time frame: intraoperative
Time to Successful Intubation
Time frame: intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ronald B George, MD principal investigator
IWK Health Centre
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laryngoscopy order: 1) MAC, 2) Levitan and Laryngoscopy order: 1) Levitan, 2) MAC in people with Airway Complication of Anaesthesia, run by IWK Health Centre.
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 4 inclusion and 4 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 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cormack-Lehane Grade (time frame: intraoperative). 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 10 Mar 2015.