An interventional study of Orotracheal intubation in infants with Macintosh and Orotracheal intubation in infants with King vision in Orotracheal Intubation in Infants Requiring General Anaesthesia for Surgery, sponsored by Jawaharlal Institute of Postgraduate Medical Education & Research. Completed at 1 site in India. Open to participants aged 1 Day to 1 Year, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Jawaharlal Institute of Postgraduate Medical Education & Research · Not applicable, Interventional, and Treatment
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?
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.
Jawaharlal Institute of Postgraduate Medical Education & Research is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
Procedure: 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 King vision videolaryngoscope
Procedure: Orotracheal intubation in infants with King vision
Orotracheal intubation in infants using Macintosh laryngoscope
Orotracheal intubation in infants with King vision videolaryngoscope
First attempt intubation success rate
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.
Time frame: 0 - 15 minutes
Cormack-Lehane grading (CL grade)
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.
Time frame: 0 - 15 minutes
Percentage of glottic opening score (POGO score)
Comparison of POGO scoring(with and without BURP manuever) using King vision and Macintosh laryngoscope will done in he study
Time frame: 0 - 15 minutes
Ease of insertion
Comparison of ease of insertion of King vision and Macintosh laryngoscope will be done based on a 5 point Likert scale.
Time frame: 0 - 15 minutes
Mean intubation time
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.
Time frame: 0 - 15 minutes
Plan to share: No
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Jawaharlal Institute of Postgraduate Medical Education & Research