NCT03378154

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

November 8, 2017

Last Update Submit

April 14, 2019

Conditions

Orotracheal Intubation in Infants Requiring General Anaesthesia for Surgery

Keywords

King visionDifficult airwayVideolaryngoscopePaediatric intubation

Outcome Measures

Primary Outcomes (1)

  • 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.

    0 - 15 minutes

Secondary Outcomes (4)

  • Cormack-Lehane grading (CL grade)

    0 - 15 minutes

  • Percentage of glottic opening score (POGO score)

    0 - 15 minutes

  • Ease of insertion

    0 - 15 minutes

  • Mean intubation time

    0 - 15 minutes

Study Arms (2)

Tracheal Intubation in infants using Macintosh laryngoscopes

EXPERIMENTAL

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

Tracheal Intubation in infants using King vision

EXPERIMENTAL

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

Interventions

Orotracheal intubation in infants with MacintoshPROCEDURE

Orotracheal intubation in infants using Macintosh laryngoscope

Tracheal Intubation in infants using Macintosh laryngoscopes
Orotracheal intubation in infants with King visionPROCEDURE

Orotracheal intubation in infants with King vision videolaryngoscope

Tracheal Intubation in infants using King vision

Eligibility Criteria

Age1 Day - 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JIPMER

Puducherry, 605006, India

Location

Related Publications (3)

  • 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.

    PMID: 28217398BACKGROUND

  • 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.

    PMID: 27293429BACKGROUND

  • 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.

    PMID: 19128325BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 8, 2017

First Posted

December 19, 2017

Study Start

January 1, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)