- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02482870
Efficiency of the King Vision Video Laryngoscope
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rize, Turkey, 53100
- Recep Tayyip Erdogan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Macintosh
Patients scheduled for general anesthesia during the study period, who had been intubated with Macintosh laryngoscope first and then with KingVision videolaryngoscope.
|
Using a Macintosh laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
Using a King Vision video laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
|
Active Comparator: KingVision
Patients scheduled for general anesthesia during the study period, who had been intubated with King Vision videolaryngoscope first and then with Macintosh laryngoscope.
|
Using a Macintosh laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
Using a King Vision video laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intubation Success Rate
Time Frame: less than 24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intubation Time
Time Frame: less than 24 hours
|
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
|
Cormack-Lehane Score
Time Frame: less than 24 hours
|
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
Time Frame: The participants' will be followed for the duration of hospital stay, an expected average of 2 days
|
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
|
Glottic View Time
Time Frame: less than 24 hours
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Başar Erdivanli, Asst. Prof., Recep Tayyip Erdogan Univeristy, Medical Faculty, Department of Anesthesiology and Reanimation
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Respiratory Failure
-
Poitiers University HospitalRecruitingAcute Respiratory Failure | Hypoxemic Respiratory FailureFrance
-
Catholic University of the Sacred HeartFisher and Paykel HealthcareCompletedWeaning Failure | Acute Respiratory FailureFrance, Greece, Italy, Spain
-
Hemovent GmbHMAXIS Medical, LLCActive, not recruitingRespiratory Failure | Cardiac Failure | Cardio-Respiratory FailureGermany
-
UPECLIN HC FM Botucatu UnespUnknownExtubation Failure | Acute Respiratory Failure Post ExtubationBrazil
-
Hospital Clinic of BarcelonaCompletedHypercapnic Respiratory Failure | Hypoxemic Respiratory FailureSpain
-
Efficacy Care R&D LtdMemorial Hermann Hospital; CRG Medical, Inc.UnknownShock | Shock, Septic | Respiratory Failure | Respiratory Distress Syndrome | Shock, Cardiogenic | Acute Cardiac Failure | Acute Respiratory Failure | Acute Kidney Failure | Multi Organ Failure | Respiratory Arrest | Acute Respiratory Failure With Hypoxia | Acute Respiratory Failure Requiring Reintubation | Acute... and other conditionsUnited States
-
University Hospital, AngersNot yet recruitingCardio-Respiratory FailureFrance
-
University Hospital, MotolCompletedRefractory Respiratory FailureCzechia
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedDevelopment of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery RoomNeonatal Respiratory FailureTurkey
-
Siriraj HospitalRecruitingAcute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory FailureThailand
Clinical Trials on Macintosh laryngoscope
-
Indonesia UniversityCompleted
-
Manuel Ángel Gómez-RíosCompletedNasotracheal IntubationSpain
-
The University of Texas Health Science Center,...KARL STORZ Endoscopy-America, Inc.CompletedIntubation, EndotrachealUnited States
-
General Hospital LinzCompleted
-
Alexandria UniversityCompletedTo Evaluate the Clinical Outcome (Complications) of Emergency Endotracheal Intubation in Non-traumatic PatientsEgypt
-
The University of Texas Health Science Center,...Completed
-
Ankara UniversityCompletedAll the Pediatric Patients Needed Intubation for SurgeryTurkey
-
Government Medical College, HaldwaniCompletedIntubation; Difficult
-
Aga Khan UniversityRecruitingThoracic Neoplasms | Thoracic Diseases | Thoracic EmpyemaPakistan
-
Van Bölge Eğitim ve Araştırma HastanesiCompleted