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Supreme Versus Proseal Laryngeal Mask Airways in Infants

Comparison of the Supreme™ And Proseal™ Laryngeal Mask Airways in Infants: A Prospective Randomised Clinical Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03251105
Enrollment
120
Registered
2017-08-16
Start date
2016-04-27
Completion date
2017-01-31
Last updated
2017-08-16

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

Conditions

Anesthesia, Infant Conditions, Surgery

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.

Interventions

DEVICEsupraglottic airway intubation

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
performance characteristicsoperation durationinsertion time in minutes

Secondary

MeasureTime frameDescription
haemodynamicsoperation durationend tidal CO2 (EtCO2) in mmHg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026