Comparison of laryngeal mask airway supremeTM as non-inflatable cuff device and self-pressurized air-QTM in children: Randomized controlled non-inferiority study.
Medicine (Baltimore)
; 98(10): e14746, 2019 Mar.
Article
em En
| MEDLINE
| ID: mdl-30855468
ABSTRACT
BACKGROUND:
Supraglottic airway (SGA) device with non-inflatable cuff reduce the airway complications associated with cuff hyperinflation. The aim of the study is to determine whether the default setting of Supreme is as effective as the non-inflatable cuff devices. The oropharyngeal leak pressure was measured and compared between the Supreme and Air-Q, a typical non-inflatable cuff device. We hypothesized that the default setting of Supreme is non-inferior to the the Air-Q self-pressurized (SP) in respect to the oropharyngeal leak pressure.METHODS:
Eighty-four patients aged 1 to 7 years who were scheduled for general anesthesia, participated in the study. The patients were randomly assigned to Supreme group (nâ=â41) or Air-Q SP group (nâ=â43). We considered that the primary outcome, oropharyngeal leak pressure of Supreme group would be non-inferior to the Air-Q SP group, within 3âcmH2O. Other outcomes included tidal volume loss, difficulty of insertion, insertion time, and complications.RESULTS:
The oropharyngeal leak pressure of the Supreme and Air-Q SP was 19.9â±â4.1âcm H2O and 17.4â±â2.9âcm H2O, respectively. The mean differences of 2 devices (Air-Q SP-Supreme) were -2.5âcm H2O, (95% confidence interval [-4.0 to -0.9], Pâ=â.002). The upper CI was smaller than the non-inferiorty margin (3âcm H2O). This result suggested that the default setting of Supreme was superior to the Air-Q SP with respect to the oropharyngeal leak pressure. However, there were no significant differences in tidal volume loss over time, ease of device insertion score, insertion time, and complications.CONCLUSIONS:
The Supreme can be used in the default setting in pediatric patients accordingly in terms of tolerable leak pressure and the stability for mechanical ventilation compared with Air-Q SP.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Respiração Artificial
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Máscaras Laríngeas
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Manuseio das Vias Aéreas
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Complicações Intraoperatórias
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Anestesia Geral
Tipo de estudo:
Clinical_trials
/
Etiology_studies
Limite:
Child
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Child, preschool
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Female
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Humans
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Infant
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Male
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article