Respiratory Failure Clinical Trial
Official title:
Comparison of King Vision Video Laryngoscope and Macintosh Laryngoscope in Terms of First Pass Intubation Success Rate, Intubation Time, Glottic View Time, and Complications Related to Laryngoscopy
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 |
Verified date | December 2023 |
Source | Recep Tayyip Erdogan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Recep Tayyip Erdogan University | Rize |
Lead Sponsor | Collaborator |
---|---|
Recep Tayyip Erdogan University |
Turkey,
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
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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