Comparing the Efficacy of King Vision in Infants

Not Applicable

Completed

• Conditions: Orotracheal Intubation in Infants Requiring General Anaesthesia for Surgery
• Interventions: Procedure: Orotracheal intubation in infants with King vision; Procedure: Orotracheal intubation in infants with Macintosh

• Registration Number: NCT03378154
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education & Research

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.

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-12-17
• Study First Posted: 2017-12-19
• Study Start: 2018-01-01
• Status Verified: 2019-04
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Last Update Submitted: 2019-04-14
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tracheal Intubation in infants using King vision	Orotracheal intubation in infants with King vision	Children \< 1 year of age posted for elective or emergency surgical procedure will be administered general anaesthesia by means of orotracheal intubation with the help of the King vision videolaryngoscope
Tracheal Intubation in infants using Macintosh laryngoscopes	Orotracheal intubation in infants with Macintosh	Children \< 1 year of age posted for elective or emergency surgical procedure will be administered general anaesthesia by means of orotracheal intubation with the help of the Macintosh laryngoscope

Primary Outcome Measures

Name	Time	Method
First attempt intubation success rate	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 Outcome Measures

Name	Time	Method
Percentage of glottic opening score (POGO score)	0 - 15 minutes	Comparison of POGO scoring(with and without BURP manuever) using King vision and Macintosh laryngoscope will done in he study
Mean intubation time	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.
Ease of insertion	0 - 15 minutes	Comparison of ease of insertion of King vision and Macintosh laryngoscope will be done based on a 5 point Likert scale.
Cormack-Lehane grading (CL grade)	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.

Trial Locations

Locations (1)

JIPMER; 🇮🇳 Pondicherry, India