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A study to assess ease of intubation with or without intubation pillow in paediatric age group.

Not yet recruiting
Conditions
Encounter for other plastic and reconstructive surgery following medical procedure or healed injury,
Registration Number
CTRI/2020/01/022942
Lead Sponsor
CMC vellore
Brief Summary

The study aimsto assess the role of intubation pillow versus no pillow in paediatricintubation by assessing the Cormack and Lehane Laryngoscopy grade. This will bea randomized controlled study where children between 5 to 12years of age whoare undergoing elective surgery requiring endotracheal intubation, who consentfor the study will be randomized into two groups. The laryngoscopy will be doneusing an intubation pillow in group 1 and without intubation pillow in group 2.

 Thelaryngoscopy will be performed by primary investigator, an anaesthetist, whohas done at least 50 paediatric intubations along with consultant who hasexperience in paediatric anaesthesia. The scopies will be compared and studywill be started if the scopies are similar 75% of the time.

 The child willbe premedicated with syrup Trichloryl 75mg/kg one hour before the start ofanaesthesia. A silicon teeth guard will be used to cover the teeth. The childwill be induced in theatre with Sevoflurane (MAC intubation of 1.3), Fentanyl 1to 2 microgram per kilogram, and atracurium 0.5 milligram per kilogram.  In children who allow an intravenous line,Propofol 1.5 to 2.5 milligram per kilogram will be used for induction of anaesthesiainstead of sevoflurane. Sevoflurane will be used to maintain anaesthesia.Laryngoscopy will be done using Macintosh Blade five minutes afteradministration of the muscle relaxant. The primary investigator will compareCormack and Lehane grade. For children between 5 to 9 years of age a 4 cmpillow will be used and for age group between 10 and 12, a 6cm pillow will beused.  This data will be thenanalyzed.  The study hypothesizes that ahead elevation using the intubation pillow will facilitate a betterlaryngoscopy grade when compared to the traditional head neutral technique.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
68
Inclusion Criteria
  • All children between age group of 5 to 12 years.
  • 2.ASA I and II 3.Normal neck movement.
Exclusion Criteria
  • 1.No parental consent.
  • 2.Children less than 5 years of age or more than 12-year-old.
  • 3.ASA III or more 4.GCS less than 15 5.Limited neck extension 6.Craniofacial anomalies.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary Outcome: Assessment of Cormack and Lehane grade of laryngoscopyOctober 2020
Secondary Outcome Measures
NameTimeMethod
1.Assessment of BURP (Backwards Upwards Rightwards Pressure) maneuver to improve laryngoscopy grade.2.Assessment of POGO score (Percentage Of Glottic Opening)

Trial Locations

Locations (1)

cmc vellore ,Main Theatre complex, Peadiatric theatre- OR- 1,OR- 2, 2A, 3, 3A, ENT- OR

🇮🇳

Chennai, TAMIL NADU, India

cmc vellore ,Main Theatre complex, Peadiatric theatre- OR- 1,OR- 2, 2A, 3, 3A, ENT- OR
🇮🇳Chennai, TAMIL NADU, India
SONYA SUSAN GEORGE
Principal investigator
7868062130
sonyasusangeorge14@rediffmail.com

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