Comparison of two airway devices named I-gel and Proseal LMA used to give anesthesia in children in different head and neck positions

Comparison of I-Gelâ?¢ Airway with laryngeal mask airway prosealâ?¢ in different head and neck positions in paralysed children â??prospective,randomized trial.

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/09/006155

Enrollment

Registered

2015-09-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Igel: Measuring OPLP, Fiberoptic grading,Ventilatory parameters in different head and neck positions with Igelafter 3 minutes of insertion of the device. Control Intervention1: Proseal

Eligibility

Inclusion criteria

Inclusion criteria: children scheduled to undergo elective lower abdominal surgeries and urological procedures in supine position requiring general anaesthesia will be included in the study.

Exclusion criteria

Exclusion criteria: Upper respiratory tract infection (cough, fever, rhinorrhea) at the day of surgery,Respiratory tract pathology ( oropharynx, larynx ),Anticipated difficult airway,Children at increased risk of aspiration - Gastro esophageal reflux disease, non fasting status,Hiatus hernia,Lung diseases,Cardiorespiratory or cerebrovascular disease and Limited head and neck movements.

Design outcomes

Primary

Measure	Time frame
To compare the oropharyngeal leak pressure of I gel with LMA Proseal in different head and neck positions i.e. neutral, maximum flexion, maximum extension.Timepoint: After 2 minutes of each position change namely after flexion,extension and neutral.	—

Secondary

Measure	Time frame
â?¢ We will also compare ease of insertion, insertion attempts, manoeuvres required, failed attempt and the hemodynamic response to insertion of the device. The ventilation scoring, Fiberoptic grading and passage of gastric tube in neural, maximum flexion and maximum extension with both the study devices will also be comparedTimepoint: ease of insertion, insertion attempts, manoeuvres required, failed attempt-Just after insertion of the device Hemodynamic response- every minute after intubation till 10 minutes of insertion of the device	—

Measure

Time frame

â?¢ We will also compare ease of insertion, insertion attempts, manoeuvres required, failed attempt and the hemodynamic response to insertion of the device. The ventilation scoring, Fiberoptic grading and passage of gastric tube in neural, maximum flexion and maximum extension with both the study devices will also be comparedTimepoint: ease of insertion, insertion attempts, manoeuvres required, failed attempt-Just after insertion of the device Hemodynamic response- every minute after intubation till 10 minutes of insertion of the device

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Countries

India

Contacts

Public ContactDr Divya Jain

PGIMER

jaindivya77@rediffmail.com

Outcome results