Skip to main content
OpenTrials
Completed

NCT Number: NCT03378154

Comparing the Efficacy of King Vision in Infants

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?

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JIPMER

Puducherry, 605006, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orotracheal intubation in infants with Macintosh

Procedure

Orotracheal intubation in infants using Macintosh laryngoscope

Orotracheal intubation in infants with King vision

Procedure

Orotracheal intubation in infants with King vision videolaryngoscope

Primary outcomes

  1. First attempt intubation success rate

    Time frame: 0 - 15 minutes

    Comparison of first attempt intubation success rate of King vision videolaryngoscope and the Macintosh laryngoscope in children < 1 year. A total of two laryngoscopy attempts each lasting not more than 60 secs will be allowed. Inability to secure the airway by means of successful orotracheal intubation within the 2 attempts will be taken as a failure. Success rates of both the devices will be compared in the study.

Secondary outcomes

  1. Cormack-Lehane grading (CL grade)

    Time frame: 0 - 15 minutes

    Comparison of Cormack-Lehane grading using King vision and Macintosh laryngoscope. CL grading is a 4 point grading system used to classify the glottic view obtained while performing laryngoscopy (CL 1,2,3,4). A better CL grade obtained is associated with a higher success rate. CL grade obtained with both the devices will be compared in the study.

  2. Percentage of glottic opening score (POGO score)

    Time frame: 0 - 15 minutes

    Comparison of POGO scoring(with and without BURP manuever) using King vision and Macintosh laryngoscope will done in he study

  3. Ease of insertion

    Time frame: 0 - 15 minutes

    Comparison of ease of insertion of King vision and Macintosh laryngoscope will be done based on a 5 point Likert scale.

  4. Mean intubation time

    Time frame: 0 - 15 minutes

    Comparison of Mean intubation time of King vision video laryngoscope and Macintosh laryngoscope in children< 1 year of age. Mean intubation time will be taken as the time between the scope passing the teeth to the appearance of the first end tidal Co2(EtCo2) curve.

Sponsors and collaborators

Lead sponsor

Jawaharlal Institute of Postgraduate Medical Education & Research

Other Gov

Registry information

Official study title

Intubation Success and Glottis Visualization With King Vision Video Laryngoscope as Compared to Conventional Laryngoscopes in Children < 1 Years: A Randomized Control Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.