Supreme Versus Proseal Laryngeal Mask Airways in Infants

Sisli Hamidiye Etfal Training and Research Hospital

Status: Completed

Conditions: Surgery; Infant Conditions; Anesthesia

Treatments: Device: supraglottic airway intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT03251105

SEEAH/26.04.2016/659

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

ProSeal group

Active Comparator group

Description:

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

Treatment:

Device: supraglottic airway intubation

Supreme group

Active Comparator group

Description:

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

Treatment:

Device: supraglottic airway intubation