Clinical trial NCT03378154: Comparing the Efficacy of King Vision in Infants
Official title: Intubation Success and Glottis Visualization With King Vision Video Laryngoscope as Compared to Conventional Laryngoscopes in Children < 1 Years: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orotracheal Intubation in Infants Requiring General Anaesthesia for Surgery
Keywords: King vision
Difficult airway
Videolaryngoscope
Paediatric intubation
Lead sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research
Sponsor class: OTHER_GOV
First posted: 2017-12-19
Enrollment: 78
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to find out whether the intubation success rates of Kingvision video laryngoscope is better than that of the conventional laryngoscopes in children \< 1 year of age?

Detailed description: Securing the airway by tracheal intubation is one of the most critical steps during administration of general anesthesia to infants. Failure or a delay in tracheal intubation leads to severe hypoxic insult to infants as the oxygen consumption is high in them when compared to adults.Smaller caliber of the pediatric airway, relatively large tongue, anteriorly located larynx, floppy and relatively large epiglottis predispose young children to airway obstruction during Anaesthesia. In addition, the large occiput of the infant places the head and neck in the flexed position when the patient is placed recumbent, further exacerbating airway obstruction

Direct laryngoscopy requires a direct line of sight for proper glottis visualization which is achieved by proper alignment of airway axes (oral-pharyngeal-laryngeal). These manipulations can lead to significant hemodynamic disturbance, cervical instability, injury to oral and pharyngeal tissues and dental damage. In contrast to direct laryngoscopy, video laryngoscope utilizes indirect laryngoscopy via its camera and helps improve glottic visualization, thereby minimizing complications

New age videolaryngoscopes with their unique design provide better glottis visualization without the requirement of proper alignment of oral-pharyngeal-laryngeal axes, thereby minimizing the complications associated with excessive manipulation and hence provide a decent edge over the conventional indirect laryngoscopes routinely used. With the above mentioned advantages these videolaryngoscopes can be efficiently used in both elective as well as emergencysettings in infants for intubation The investigators in this study will be evaluating the efficacy of King vision video laryngoscope when compared to the conventional laryngoscopes in routine use for infants.

Eligibility criteria: Inclusion Criteria

* Patients of the age group 0-1 years undergoing elective or emergency surgeries belonging to American Society ofAnaesthesiologists(ASA) physical status classification 1-2 and requiring administration of General Anaesthesia with orotracheal intubation

Exclusion Criteria:

* Patients with anticipated difficult airways
* Patients with aspiration risk or requiring Rapid sequence induction (RSI)
* Patients with laryngeal or tracheal pathologies
* Cervical spine injury
* Active respiratory infection or lung disease

Primary outcomes:
measure: First attempt intubation success rate
timeFrame: 0 - 15 minutes
Secondary outcomes:
measure: Cormack-Lehane grading (CL grade)
timeFrame: 0 - 15 minutes
measure: Percentage of glottic opening score (POGO score)
timeFrame: 0 - 15 minutes
measure: Ease of insertion
timeFrame: 0 - 15 minutes
measure: Mean intubation time
timeFrame: 0 - 15 minutes
Other outcomes:
Locations:
city: Pondicherry
country: India
facility: JIPMER
Study officials:
References:
citation: Shravanalakshmi D, Bidkar PU, Narmadalakshmi K, Lata S, Mishra SK, Adinarayanan S. Comparison of intubation success and glottic visualization using King Vision and C-MAC videolaryngoscopes in patients with cervical spine injuries with cervical immobilization: A randomized clinical trial. Surg Neurol Int. 2017 Feb 6;8:19. doi: 10.4103/2152-7806.199560. eCollection 2017.
citation: Sinha R, Sharma A, Ray BR, Kumar Pandey R, Darlong V, Punj J, Chandralekha C, Upadhyay AD. Comparison of the Success of Two Techniques for the Endotracheal Intubation with C-MAC Video Laryngoscope Miller Blade in Children: A Prospective Randomized Study. Anesthesiol Res Pract. 2016;2016:4196813. doi: 10.1155/2016/4196813. Epub 2016 May 15.
citation: Holm-Knudsen RJ, Rasmussen LS. Paediatric airway management: basic aspects. Acta Anaesthesiol Scand. 2009 Jan;53(1):1-9. doi: 10.1111/j.1399-6576.2008.01794.x.