Comparing the Efficacy of King Vision in Infants

NCT ID: NCT03378154

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-04-01

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.

Conditions

Orotracheal Intubation in Infants Requiring General Anaesthesia for Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tracheal Intubation in infants using Macintosh laryngoscopes

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

Group Type: EXPERIMENTAL

Orotracheal intubation in infants with Macintosh

Intervention Type: PROCEDURE

Orotracheal intubation in infants using Macintosh laryngoscope

Tracheal Intubation in infants using 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

Group Type: EXPERIMENTAL

Orotracheal intubation in infants with King vision

Intervention Type: PROCEDURE

Orotracheal intubation in infants with King vision videolaryngoscope

Interventions

Orotracheal intubation in infants with Macintosh

Orotracheal intubation in infants using Macintosh laryngoscope

Intervention Type: PROCEDURE

Orotracheal intubation in infants with King vision

Orotracheal intubation in infants with King vision videolaryngoscope

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jawaharlal Institute of Postgraduate Medical Education & Research

OTHER_GOV

Sponsor Role: lead

Responsible Party

M Manov

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

JIPMER

Puducherry, , India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 28217398 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27293429 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19128325 (View on PubMed)

Other Identifiers

JIP/IEC/2017/0273

Identifier Type: -

Identifier Source: org_study_id