Study of two devices for management of airway during anaesthesia in children

Recruiting

Registration Number: CTRI/2020/01/022970

Lead Sponsor: Llady hardinge medical college

Brief Summary: Supraglottic airway device (SAD) is commonly used in adults and children to secure airway during general anaesthesia. Different types of SAD are used. I-gel and laryngeal mask airway supreme (LMA supreme) are 2nd generation single use SADs with an integral bite block, the difference being the cuff. Whereas the LMA supreme has an inflatable cuff, i-gel is made from medical grade thermoplastc elastomer.

I-gel has been designed to create a non-inflatable, anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding compression trauma.

LMA supreme has two seals: first seals the oropharynx and second the upper esophageal sphincter. The importance of the second seal is significant: it can minimize gastric insufflation and reduce the risk of aspiration.

A drain tube in both devices, which lies over the top of the oesophagus when the SAD is correctly positioned, may be used to: assist insertion, enable access to the stomach, alert the user to presence of regurgitation and enable gastric contents to safely bypass the oropharynx and exit the patient.

Optimal placement of SADs may be confirmed by oropharyngeal leak pressures (OLP) and fiberoptic view.

SADs are manufactured to conform to the anatomy of adult larynx, but paediatric larynx is different anatomically from the adult. The paediatric sizes of SADs are miniaturized versions of the adult device and may not conform to the paediatric anatomy thus resulting in suboptimal ventilation.

Several studies have compared the i-gel and LMA supreme in adults. However, in children (less than or equal to 10kg) there is paucity of literature regarding which SAD provides the best fit as evidenced by OLP.

Hence the present study will be undertaken to compare the oropharyngeal leak pressure (OLP) of i-gel and LMA supreme in the airway management of children

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 80

Inclusion Criteria

1.Either sex 2.less than or equal to 10kg of body weight 3.ASA grade I & II 4.Adequate nutritional status ( -2 to +2 z scores for weight for age).

Exclusion Criteria

1.Congenital airway abnormality 2.Anticipated difficult airway 3.Upper respiratory infections 4.Risk of aspiration (gastrointestinal obstruction, pyloric stenosis).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Â± SD of Oropharyngeal leak pressure (OLP) in i-gel and LMA supreme.	after successful insertion of device

Secondary Outcome Measures

Name	Time	Method
Proportion of patients in whom device could be inserted easily in both groups	After successful insertion of device
Proportion of successful insertion at 1st attempt in both groups	After successful insertion of device
Proportion of number of manipulations in both groups	After successful insertion of device
Proportion of number of insertion attempts in both groups	After successful insertion of device
Mean Â± SD of insertion time (seconds) in both groups	After successful insertion of device
Fiberoptic view of larynx grading in both groups	After successful insertion of device
Proportion of perioperative complications in both groups	After successful removal of device

Trial Locations

Locations (1): Operation theatre in lady Hardinge medical college and associate hospitals
🇮🇳
Central, DELHI, India
Operation theatre in lady Hardinge medical college and associate hospitals
🇮🇳Central, DELHI, India
ashutosh singh
Principal investigator
9990999198
ASHUTOSHSINGHRAJAWAT@GMAIL.COM