Supreme Versus Proseal Laryngeal Mask Airways in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-27

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgery Infant Conditions Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Infants, who were scheduled to undergo lower abdominal surgery and to receive anaesthesia

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ProSeal group

This group received the ProSeal LMA for supraglottic airway intubation and ventilation during anaesthesia.

Group Type ACTIVE_COMPARATOR

supraglottic airway intubation

Intervention Type DEVICE

Supreme group

This group received the Supreme LMA for supraglottic airway intubation and ventilation during anaesthesia.

Group Type ACTIVE_COMPARATOR

supraglottic airway intubation

Intervention Type DEVICE

Interventions

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supraglottic airway intubation

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes