Supreme Versus Proseal Laryngeal Mask Airways in Infants

Not Applicable

Completed

• Conditions: Anesthesia; Infant Conditions; Surgery

• Registration Number: NCT03251105
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary

In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.

Detailed Description

Both the Supreme™ and ProSeal™ laryngeal mask airways (LMAs) are widely used for paediatric anaesthesia; however, LMA use in infants is limited, as many anaesthesiologists prefer to use tracheal intubation in infants.

In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.

Infants of ASA physical status I who were scheduled for elective, minor, lower abdominal surgery were divided into two groups: the Supreme LMA group and the ProSeal LMA group. Heart rate (HR), oxygen saturation and end tidal carbon dioxide values were recorded both before and after LMA insertion, as well as both before and after extubation. After extubation, complications and adverse effects were noted.

Demographics and surgical data were similar between the two groups. LMA insertion times for the ProSeal group were shorter, the leakage pressure for the ProSeal group was statistically higher. The ProSeal LMA is superior to the Supreme LMA for use in infants, due to its ease of insertion, high oropharyngeal leakage pressure and fewer induced changes in hemodynamics.

Study Timeline

• Study Start: 2016-04-27
• Primary Completion: 2016-12-31
• Study Completion: 2017-01-31
• Status Verified: 2017-08
• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-11
• Last Update Submitted: 2017-08-11
• Study First Posted: 2017-08-16
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• scheduled for elective, minor (<1 hour duration), lower abdominal surgery, including unilateral herniorrhaphy and unilateral orchidopexy

Exclusion Criteria

• premature birth, potentially difficult airway, clinically significant upper respiratory tract infection and risk of aspiration, such as gastro-oesophageal reflux disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
performance characteristics	operation duration	insertion time in minutes

Secondary Outcome Measures

Name	Time	Method
haemodynamics	operation duration	end tidal CO2 (EtCO2) in mmHg