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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02482870
Other study ID # 2014/109
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date November 2014

Study information

Verified date December 2023
Source Recep Tayyip Erdogan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 388
Est. completion date November 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - scheduled for general anesthesia - age higher than 18 years - age lower than 60 years Exclusion Criteria: - emergency surgery - mouth opening less than 2 cm - American Society of Anesthesiologists (ASA) score higher than 2 - oropharyngeal anomaly - glottic or supraglottic mass - history of surgery due to oropharyngeal anomaly, glottic or supraglottic mass

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Macintosh laryngoscope
Using a Macintosh laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
King Vision video laryngoscope
Using a King Vision video laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.

Locations

Country Name City State
Turkey Recep Tayyip Erdogan University Rize

Sponsors (1)

Lead Sponsor Collaborator
Recep Tayyip Erdogan University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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]. less than 24 hours
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. 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:
full view of glottis (difficult intubation unlikely)
partial view of glottis (~5% risk of difficult intubation)
partial view of epiglottis, none of glottis seen (~90% risk of difficult intubation)
neither glottis nor epiglottis seen (difficult intubation very likely)
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):
full view of glottis (difficult intubation unlikely)
partial view of glottis (~5% risk of difficult intubation)
partial view of epiglottis, none of glottis seen (~90% risk of difficult intubation)
neither glottis nor epiglottis seen (difficult intubation very likely)
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. The participants' will be followed for the duration of hospital stay, an expected average of 2 days
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