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The investigators studied the efficiency of Macintosh laryngoscope and the King Vision video laryngoscope in adult patients scheduled for general anesthesia. Best Cormack-Lehane score obtained, glottic view time, intubation time, time to ventilation, correlation between the Mallampati classification and the Cormack-Lehane grades, and complications related to laryngoscopy and intubation has been investigated.
Securing the airway is essential in general anesthesia. Anesthetic problems related to airway management constitute 17% of closed claims, difficult intubation being the most common one with an occurrence rate of 5%. Problems like delayed intubation, misplaced tracheal tube, or airway trauma are frequently seen in outpatient settings and end up with either death or hypoxic brain damage. Therefore, preoperative visit should include detailed assessment of the airways according to clues of difficult intubation.Several studies compared the King Vision video laryngoscope with other laryngoscopes in manikins simulating difficult airway scenarios, and reported better glottic views. The investigators aimed to study the correlation between the Mallampati classification and the glottic views (Cormack-Lehane grade) obtained with Macintosh laryngoscopy, and the King Vision video laryngoscopy in adult patients scheduled for general anesthesia. Secondary outcomes will be successful intubation rate, time to obtain the best view, time to successful intubation, and complications related to laryngoscopy will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macintosh | Active Comparator | Patients scheduled for general anesthesia during the study period, who had been intubated with Macintosh laryngoscope first and then with KingVision videolaryngoscope. |
|
| KingVision | Active Comparator | Patients scheduled for general anesthesia during the study period, who had been intubated with King Vision videolaryngoscope first and then with Macintosh laryngoscope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macintosh laryngoscope | Device | Using a Macintosh laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Success Rate | Endotracheal intubation attempt is defined as entrance of the endotracheal tube into the patient's mouth. Any major change in the alignment of the laryngoscope is defined as another intubation attempt. Successful endotracheal intubation is defined as the endotracheal cuff passing through the patient's vocal cords. Intubation success rate is defined as: 1 / [the number of attempts]. | less than 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Time | Successful endotracheal intubation is defined as the endotracheal cuff passing the patient's vocal cords. Time to intubation with each laryngoscope is recorded. | less than 24 hours |
| Glottic View Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BaÅŸar Erdivanli, Asst. Prof. | Recep Tayyip Erdogan Univeristy, Medical Faculty, Department of Anesthesiology and Reanimation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recep Tayyip Erdogan University | Rize | 53100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21550550 | Background | Metzner J, Posner KL, Lam MS, Domino KB. Closed claims' analysis. Best Pract Res Clin Anaesthesiol. 2011 Jun;25(2):263-76. doi: 10.1016/j.bpa.2011.02.007. | |
| Background | Woodall NM, Benger JR, Harper JS, Cook TM. Airway management complications during anaesthesia, in intensive care units and in emergency departments in the UK". Trends in Anaesthesia and Critical Care 2(2): 58-64, 2012. | ||
| 11871945 |
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None of the 388 patients enrolled between January 2014 and July 2014 were excluded from the trial.
This study enrolled adult patients scheduled for general anesthesia with intubation in Recep Tayyip Erdogan University Education and Research Hospital. The last patient completed in July 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Macintosh First, Then King Vision | The patients has been intubated first with a Macintosh, then with a King Vision video laryngoscope. |
| FG001 | King Vision First, Then Macintosh | The patients has been intubated first with a King Vision video laryngoscope, then with a Macintosh laryngoscope. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adult patients scheduled for general anesthesia with endotracheal intubation.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Each patient were intubated with both Macintosh and King Vision video laryngoscope sequentially. The order of the laryngoscopes was randomized by flipping a coin. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intubation Success Rate | Endotracheal intubation attempt is defined as entrance of the endotracheal tube into the patient's mouth. Any major change in the alignment of the laryngoscope is defined as another intubation attempt. Successful endotracheal intubation is defined as the endotracheal cuff passing through the patient's vocal cords. Intubation success rate is defined as: 1 / [the number of attempts]. | Posted | Number | participants | less than 24 hours |
|
6 months
Patients were supervised and observed for adverse events during the period they spent in the operating room, and post anesthetic care unit, by the attending anesthesiologist and anesthesia technician.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | King Vision First, Then Macintosh | These patients had been intubated with a King Vision video laryngoscope first, and then with a Macintosh laryngoscope. Airway complications related to the laryngoscopy and intubation (cuts, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%) had been recorded. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Situation of "can't intubate, can't ventilate" | Respiratory, thoracic and mediastinal disorders | Emergency | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cuts on lips | Skin and subcutaneous tissue disorders | Cuts | Systematic Assessment | Minor cuts on lips occurring due to manipulations and pressure of the laryngoscope, mostly the blade. |
Sample size estimation according to small number of participants; sequential intubation with both laryngoscopes providing an advantage to the second laryngoscope.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Başar Erdivanlı | Recep Tayyip Erdogan University School of Medicine | +904642130491 | 2128 | berdivanli@gmail.com |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Patients scheduled for general anesthesia with endotracheal intubation will be randomized to either intubation with Macintosh laryngoscope first or King Vision videolaryngoscope first. All patients will be intubated with both laryngoscopes.
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| King Vision video laryngoscope | Device | Using a King Vision video laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded. |
|
Glottic view time (as defined when the laryngoscopist declared the best Cormack-Lehane score) with each laryngoscope is recorded.
Cormack-Lehane score is obtained by directly assessing the distance between the base of the tongue and the roof of the mouth to predict how difficult an intubation will be.
It consists of 4 grades:
| less than 24 hours |
| Cormack-Lehane Score | Best Cormack-Lehane score (as declared by the laryngoscopist) obtained with both laryngoscopes is recorded. Cormack-Lehane score is graded according to the following criteria (1 is best, and 4 is worst):
| less than 24 hours |
| Airway Complications | Any complication related to the laryngoscopy and intubation, such as cut, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%, is recorded. | The participants' will be followed for the duration of hospital stay, an expected average of 2 days |
| Background |
| Yentis SM. Predicting difficult intubation--worthwhile exercise or pointless ritual? Anaesthesia. 2002 Feb;57(2):105-9. doi: 10.1046/j.0003-2409.2001.02515.x. No abstract available. |
| 23812581 | Background | Akihisa Y, Maruyama K, Koyama Y, Yamada R, Ogura A, Andoh T. Comparison of intubation performance between the King Vision and Macintosh laryngoscopes in novice personnel: a randomized, crossover manikin study. J Anesth. 2014 Feb;28(1):51-7. doi: 10.1007/s00540-013-1666-9. Epub 2013 Jun 30. |
| 24742495 | Background | Murphy LD, Kovacs GJ, Reardon PM, Law JA. Comparison of the king vision video laryngoscope with the macintosh laryngoscope. J Emerg Med. 2014 Aug;47(2):239-46. doi: 10.1016/j.jemermed.2014.02.008. Epub 2014 Apr 16. |
| 24460509 | Background | Yun BJ, Brown CA 3rd, Grazioso CJ, Pozner CN, Raja AS. Comparison of video, optical, and direct laryngoscopy by experienced tactical paramedics. Prehosp Emerg Care. 2014 Jul-Sep;18(3):442-5. doi: 10.3109/10903127.2013.864356. Epub 2014 Jan 24. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height, Continuous | Median | Inter-Quartile Range | cm |
|
| Weight, Continuous | Median | Inter-Quartile Range | kg |
|
| Body mass index, Continuous | Median | Inter-Quartile Range | kg/m^2 |
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| History of obstructive sleep apnea, Categorical | Count of Participants | Participants |
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| History of snoring, Categorical | Count of Participants | Participants |
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| Mallampati class, Categorical | Mallampati class is used to indirectly assess the distance between the base of the tongue and the roof of the mouth, to predict how difficult an intubation will be. | Count of Participants | Participants |
|
| American Society of Anesthesiologists score, Categorical | "American Society of Anesthesiologists score" is a widely used grading system for preoperative health of the surgical patients. It is based on five classes (I to V): I-a completely healthy fit patient. II-patient has mild systemic disease. III-patient has severe systemic disease that is not incapacitating. IV-patient has incapacitating disease that is a constant threat to life. V-a moribund patient, not expected to live 24 hour w/out surgery. E-designates emergency surgery (added after roman literal like "IIE"). | Count of Participants | Participants |
|
| Thyromental distance, Continuous | Median | Inter-Quartile Range | cm |
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| Sternomental distance, Continuous | Median | Inter-Quartile Range | cm |
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| Interincisor distance, Continuous | Median | Inter-Quartile Range | cm |
|
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|
|
| Secondary | Intubation Time | Successful endotracheal intubation is defined as the endotracheal cuff passing the patient's vocal cords. Time to intubation with each laryngoscope is recorded. | Posted | Median | Inter-Quartile Range | seconds | less than 24 hours |
|
|
|
|
| Secondary | Glottic View Time | Glottic view time (as defined when the laryngoscopist declared the best Cormack-Lehane score) with each laryngoscope is recorded. Cormack-Lehane score is obtained by directly assessing the distance between the base of the tongue and the roof of the mouth to predict how difficult an intubation will be. It consists of 4 grades:
| Posted | Median | Inter-Quartile Range | seconds | less than 24 hours |
|
|
|
|
| Secondary | Cormack-Lehane Score | Best Cormack-Lehane score (as declared by the laryngoscopist) obtained with both laryngoscopes is recorded. Cormack-Lehane score is graded according to the following criteria (1 is best, and 4 is worst):
| Posted | Number | participants | less than 24 hours |
|
|
|
|
| Secondary | Airway Complications | Any complication related to the laryngoscopy and intubation, such as cut, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%, is recorded. | Posted | Number | participants | The participants' will be followed for the duration of hospital stay, an expected average of 2 days |
|
|
|
|
| 6 |
| 202 |
| 0 |
| 202 |
| 3 |
| 202 |
| EG001 | Macintosh First, Then King Vision | These patients had been intubated with a Macintosh laryngoscope first, and then with a King Vision video laryngoscope. Airway complications related to the laryngoscopy and intubation (cuts, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%) had been recorded. | 4 | 186 | 0 | 186 | 3 | 186 |
| Laryngospasm/Bronchospasm | Respiratory, thoracic and mediastinal disorders | Bronchospasm | Systematic Assessment |
|
| Desaturation below 90% | Respiratory, thoracic and mediastinal disorders | Desaturation | Systematic Assessment | Fall of saturation of peripheral oxygen below 90% |
|
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| Dental damage | Surgical and medical procedures | Teeth | Systematic Assessment | Any kind of dental damage, such as enamel fracture or avulsion during laryngoscopy, were recorded. |
|
| Sore throat | Skin and subcutaneous tissue disorders | SoreThroat | Systematic Assessment | Any case of painful or swollen throat were questioned at the entrance to and exit from the postanesthetic care unit by the anesthesia technician, and in the surgical ward by the nurse. |
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| 3 - Only the epiglottis is visible |
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| 4 - No laryngeal structures are visible |
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| Superiority or Other (legacy) |